Page 1

Issue 4 - Autumn/ Winter - December 2016/2017

www.ipimedia.com International Pharmaceutical Industry

Supporting the industry through communication

IPI – International Pharmaceutical Industry www.ipimedia.com

Outsourcing & Innovation Supplement 2016/2017


NEW SCHOTT perfeXionTM

The New Era of Quality Processing has already started! The transition from statistical quality control to 100 % realtime inspection of each individual FIOLAXŽ tube enables our customers to tailor dimensional and cosmetic quality of glass tubing to specific packaging requirements. What‘s your next milestone?

www.schott.com/perfexion

Pharmapack Paris, Hall 4 H89 Speech Dr. Folker Steden: Feb 1st 2017, 4.00 - 4.30 pm

SCHOTT AG, Tubing, info.tubing@schott.com, Phone +49 (0)9633/80-0


19 - 19 OWEN MUMFORD

CLINICAL RESEARCH

02 – 03 EUROFINS

International Pharmaceutical Industry

Supporting the industry through communication

Outsourcing & Innovation Supplement 2016/2017 DIRECTORS: Martin Wright Mark A. Barker

20 - 21 PRESSPART CDMO/CMO

04 – 05 ABBVIE

EDITOR: Orsolya Balogh orsolya@pharmapubs.com EDITORIAL ASSISTANT Emoke Karasz Emi@pharmapubs.com

22 - 23 SCHOTT 06 – 07 AJA PHARMA

BOOK MANAGER: Anthony Stewart anthony@ipimedia.com BUSINESS DEVELOPMENT: John Fritzgeral john@ipimedia.com DESIGN DIRECTOR: Fiona Cleland

LOGISTICS & SUPPLY CHAIN

8 - 9 GERRESHEIMER

24 - 25 BRUSSELS AIRPORT

CIRCULATION MANAGER: Dorothy Brooks dorothy@pharmapubs.com FINANCE DEPARTMENT: Martin Wright martin@ipimedia.com

10 - 11 THERAPURE Gerresheimer is a Leading Global Partner

RESEARCH & CIRCULATION: Heather Bayran Heather@pharmapubs.com … to the pharma and healthcare industry. With our specialityPUBLISHED glass and plastic BY: products, we con­ tribute to health andPublications wellbeing. We have world­ Pharma

wide operations and our Unit J413, The11,000 Biscuitemployees Factory Bridge Business Complexclose manufactureTower our products in local markets, 100 Clements to our customers. With overRoad, 40 plants in Europe, London SE16 4DG and Asia, we North America, South America

generate revenues of (0)20 approximately EUR 1.4 billion. Tel: +44 7237 2036 Our comprehensive portfolio includes Fax: +44product (0)01 480 247 5316 pharmaceutical packaging and products for the Email: info@ipimedia.com safe, simple www.ipimedia.com administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, All rights reserved. No part of this ampoules, bottles and containers liquid and publication may be for reproduced, solid medicines with closure and systems as duplicated, stored in safety any retrieval systemfor or the transmitted any form well as packaging cosmeticsin industry.

or by any means without prior written permission of the Publishers. The next supplement of IPI will be published in Autumn 2017

This publication is protected by copyright.

26 - 27 TURKISH CARGO

Therapure Biomanufacturing, a division of Therapure Biopharma, Inc. 2585 Meadowpine Blvd. Mississauga, Ontario, L5N 8H9, Canada Tel: 905-286-6206 Fax: 905-286-6300 Email: busdev@therapurebio.com Web: www.therapurebio.com/CDMO

12 - 13 VETTER

28 - 29 UPS

VITAL STATISTICS

MAJOR MARKETS

Year Founded: 2008

• North America

Number of Employees: 300

• European Union

Key Personnel: Nicholas Green, President and Chief Executive Officer; Dirk Alkema, Vice President, Operations; David N. Bell, Vice President, Drug Development and Chief Scientific Officer; Peter Dans, Chief Financial Officer

• Development: Cell Lines, Analytical Methods, Upstream and Downstream Processes

WHO WE ARE Plastics & Devices

Contract manufacturing of biologics is more than having superior technology—it’s having experienced people who are passionate, responsive and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated Contract Development and Manufacturing Organization (CDMO), Therapure Biomanufacturing, a division of Therapure Biopharma Inc., has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical and commercial). Our 136,000 ft2 (12,600m2) cGMP manufacturing facility meets FDA, EMA and HPFB regulatory standards and includes flexible clinical and commercial production suites.

SERVICES OFFERED

• cGMP Biomanufacturing From a Variety of Biological Sources Including Mammalian Cell Culture, Plasma, Transgenic Sources

• Aseptic Fill/Finish – Vials, Prefilled Syringes & The product portfolio of the Plastics & Devices Division Lyophilization includes complex, customer­specific products DELIVERY for the PACKAGING & DRUG • Full Range of Quality Control Testing simple and safe administration of medicines, such as insulin pens, inhalers and prefillable syringes. Also WWW.THERAPUREBIO.COM/CDMO included are diagnostics and medical technology products such as lancets and test systems, as well as pharmaceutical plastic containers for liquid and solid medicines with closure and safety systems. For the North American prescription retail market a complete line of regulatory compliant prescription containers for medication dispensing is available.

14 - 15 NEMERA

PRODUCTS AND EQUIPMENT

30 - 31 MIKRON

16 - 17 PCI

2016/2017 PHARMA PUBLICATIONS IPI - OUTSOURCING & INNOVATION

Our SUPPLEMENT products are important 2016/2017

186 Contract Pharma

Corporate Capabilities

therapureCPM1215.indd 186

contractpharma.com

11/4/15 10:38 AM

and convenient

Primary Packaging Glass www.ipimedia.com solutions for everyday life.

The Primary Packaging Glass Division produces glass primary packaging for medicines and cosmetics, such as pharma jars, ampoules, injection vials, cartridges, perfume flacons and cream jars.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 1


Clinical Research

Global BioPharma Product Testing Within Your Reach As the largest international network of harmonised GMP product testing labs, Eurofins BioPharma Product Testing delivers a true local service experience with the most complete range of testing services, harmonised quality systems and LIMS to more than 2000 pharmaceutical and biopharmaceutical companies worldwide. In Our World, Global Is Local Our local presence ensures personal service backed by a unique global breadth of harmonised capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation and quality control. With a global capacity of more than 65,000 square metres and 25 facilities located in Australia, Belgium, Canada,Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, UK and the US, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. Experience Our Expertise We offer complete CMC testing services for the bio/ pharmaceutical industry, including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular and cell biology, virology, chemistry and microbiology. International Presence Means Global Regulatory Compliance Operating under the same strict quality procedures, our laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopeia (EP), United States Pharmacopeia (USP) and Japanese Pharmacopeia (JP), as well as specific customer methods. Collaboration Drives Cost-effectiveness Our fundamental philosophy is to help clients efficiently allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs. As your project progresses to further enhance open dialogue and assist your decision-making, we provide timely and secure access to comprehensive laboratory information through our innovative, 24-hour online data access tool, LabAccess.com. Comprehensive Services We offer the flexibility to manage your testing programmes more efficiently through your choice of three unique service models, including our award-winning Professional Scientific Services® (PSS), full time equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals. Our breadth of services include: •

Method establishment, including method development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods

2 INTERNATIONAL PHARMACEUTICAL INDUSTRY

• • • • • •

• •

Comprehensive stability and release programmes for clinical and marketed products Complete biochemical and chemical characterisation and microbial identification Raw material and excipient testing (USP/NF, EP, JP) Production and non-production cell banking, including full characterisation Lot release/unprocessed bulk testing Process/facilities validation, including viral clearance, residual impurities testing, extractables and leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection Consulting/protocol writing GMP manufacturing

PSS Insourcing Solutions® Eurofins BioPharma Product Testing PSS Insourcing Solutions® (PSS) is our award-winning service model that places our people at your site dedicated to running and managing your laboratory services while eliminating headcount, co-employment and project-management worries. With more than 1400 employees worldwide, our PSS programme provides services at more than 65 sites in over 13 countries throughout North America and Europe, and is part of Eurofins BioPharma Product Testing, which operates 24 laboratory locations, totalling more than 700,000 ft2 across 12 countries worldwide. Eurofins BioPharma Product Testing PSS Insourcing Solutions® employs and manages full-time employees and provides a comprehensive benefits package, as well as training, development and career advancement opportunities. Offering these additional benefits allows us to attract, retain and motivate high-calibre employees to serve you. Our on-site dedicated leaders manage our full-time employees and provide you with scientific insourced services free from co-employment. PSS also solves the challenges associated with the EU Temporary Agency’s Workers Directive 2008/104. Eurofins BioPharma Product Testing pharma@eurofins.com www.Eurofins.com/Biopharma IPI Outsourcing & Innovation Supplement 2016


The Largest Global Footprint of Harmonized Testing Labs...

Right In Your Backyard.

With the largest network of harmonized bio/pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing is everywhere you are.

BioPharma Product Testing www.eurofins.com/biopharma

While delivering a true local lab experience, our international presence ensures personal quality service backed by a unique global breadth of harmonized capabilities to solve all your testing challenges. For the most complete range of global testing services, harmonized quality systems and LIMS, you’ll never need to look further than your own backyard.

Facilities

Services Chemistry/Biochemistry

Method Development & Validation

Release Testing

Cell Banking Services

Microbiology

Stability Testing & Storage

Facility & Process Validation

Molecular & Cell Biology

Viral Clearance & Viral Safety

GMP Manufacturing

Raw Materials Testing

Professional Scientific ServicesÂŽ

Australia Belgium Canada Denmark France

Germany Ireland Italy Netherlands Spain

Sweden UK US


CDMO/CMO

Fermentation Technology and Contract/Toll Manufacturing at AbbVie in North Chicago, IL

With over 65 years of experience in chemical and pharmaceutical fermentation, AbbVie Contract Manufacturing is a global leader in microbial fermentation. We offer a broad range of world-class fermentation development services and have a long-standing history of high quality commercial supply. Abbvie Contract Manufacturing has extensive experience and capacity across a wide variety of organisms including streptomycetes, actinomycetes, yeast, fungal, E. coli, and bacillus. Our expertise also includes fermentation with genetically modified organisms. AbbVie also is a multi-product approval facility and can manufacture products for a wide variety of industries, including pharmaceutical, agricultural food, nutriceutical, enzymes and chemical. What sets AbbVie apart is our proven ability to consistently meet delivery commitments thanks to our unparalleled microbial fermentation expertise and know-how, backed by an established site infrastructure to facilitate production on our 70-acre facility in North Chicago, Illinois. Fermentation Development Services When engaging in contract manufacturing projects for our clients, we bring the same level of professionalism, expertise and passion, as we do with our own internal product development and commercialisation. We offer support for products early in development including inoculum, fermentation and downstream process development and optimisation, strain improvement via classical and recombinant techniques, R&D and master cell bank creation and analytical method development and validation. AbbVie also supports later stage products including technical transfer of existing processes and optimisation to AbbVie’s manufacturing assets, analytical method transfer and scale-up to large-scale commercial manufacturing. To aid our customers in cost-efficient fermentation development, our plant includes 88 pilot scale fermenters (30 L working volume) which are an effective means to drive development, transfer and continuous improvement programmes. The pilot plant also has six 750 L fermenters, if a slightly larger scale is required. The pilot plant utilises the same process analytical technology (PAT) and process control systems as at the commercial scale pilot to design, analyse and control the manufacturing processes to ensure smooth scale-up and robust commercial processes.

4 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Fermentation Commercial Services At commercial fermentation scale, we support every aspect of a commercial operation from raw material sourcing through bulk packaging and release testing. Our offering includes over 3000 m3 GMP fermentation capacities that vary in scale from 10m3 to 100 m3 in scale with supporting seed and feed tankage. We have dedicated cell banking services including freezer storage requirements (-80oC) with backup CO2. Our downstream recovery capabilities are very diverse and include harvest options of tangential flow filtration, decantation and disk stack centrifuges, liquid/liquid extraction and filter presses, and we have large-scale purification equipment including chromatography, crystallisation and distillation. Our finishing operations include blender and fluid-bed drying, milling, blending and bulk packaging into a variety of containers. Our site infrastructure includes aerobic and anaerobic wastewater treatment. Large-scale utilities include on-site steam generation, rail access for bulk storage, access to large quantities of cooling water and chillers and dual-sourced electrical supply in case of emergencies. Optional support functions also include sourcing team to identify, qualify, purchase and test raw materials; analytical and microbiological test labs on-site to release testing requirements. Strong Culture of Continuous Improvement Our strong culture of continuous improvement employs LEAN manufacturing principles. We hold ourselves accountable through Oliver Wight Class A Certification and apply key performance indicators (KPIs) to raise the bar on business processes and product metrics. We utilise continuous improvement tools, such as Kaizen, root cause problem-solving (RCPS) methodology, 5S, Six Sigma, and total productive maintenance programme to drive the best quality and cost profile for our clients. We share our client’s goals in striving towards efficiency and continuous improvement, while being environmentally conscious and socially responsible. We implement robust compliance and quality systems that have resulted in an excellent environment, health and safety record. As part of that commitment, we have implemented numerous environment, health and safety (EH&S) programmes to ensure pollution prevention and resource conservation, including water purification through reverse osmosis, on-site hazardous waste management, as well as anaerobic and aerobic basins for pretreatment of waste water. We welcome the opportunity to understand your needs. Please, visit AbbVie’s Contract Manufacturing website for more information at www.abbviecontractmfg.com.

IPI Outsourcing & Innovation Supplement 2016


CONTRACT MANUFACTURING Biologics

|

Potent | Drug Product | Fermentation

Prefilled Syringe | Hot Melt Extrusion | APIs abbviecontractmfg.com

EXPERIENCE UNRIVALED

Fermentation

When it comes to delivering in fermentation, you need a CMO with unique knowledge that comes from 65+ years of sector leadership.


CDMO/CMO

AJA Pharma Your Reliable Partner

AJA Pharmaceutical Industries limited is a newly-established pharmaceutical manufacturing company offering a range of pharmaceutical services from regulatory and contract manufacturing to sales and marketing services to its partners. Having its head office in Riyadh, Saudi Arabia, AJA is a subsidiary of the Saudi Chemical Company (SCC) which is a leading joint stock company in the region. AJA Pharma’s sister company, Saudi International Trading Company (SITCO) is a distributor of pharmaceutical products and represents many global pharmaceutical companies in Saudi Arabia. The state of-the-art manufacturing facility of AJA Pharma is housed in an area of 120,000 square metres in the Hail city of Saudi Arabia, and produces finished dosage forms of oral solids, oral liquids and semisolids, whereas a sterile area with an isolator technology for producing injectables will be commissioned by the end of 2017. Glatt GmbH is the process and engineering consultants and has been with AJA throughout the project execution. The plant is designed in such a way by providing adequate working space to allow orderly and logical placement of equipment, materials and movement of personnel so as to comply with standards of USFDA and EMA requirements and to • • •

Avoid the risk of mix-up between different categories of drugs. Avoid the possibilities of contamination and crosscontamination by providing suitable mechanisms. All the production facilities are illuminated and effectively ventilated with air control facilities that can include temperature and humidity.

6 INTERNATIONAL PHARMACEUTICAL INDUSTRY

• • •

The conditions shall be appropriate to the categories of drugs and nature of operations. Access controls provisions are made wherever necessary to restrict the movement of the personnel and prevention of visitors’ access to operating areas. Design principles or logical workflow is considered with process flow and material flow.

AJA plant is furnished with all the necessary equipment and a qualified staff to cater for the advanced quality system needs. A warehouse with appropriate storage conditions and space is also a hallmark of the plant. AJA Pharma is partnering with leading players in the pharmaceutical industry for various licensing, tech transfer and contract manufacturing services. The company is envisioned to be the leading manufacturer in the region, with the mission to be recognised as producers of quality pharmaceutical products, and a partner of choice for the leading pharma companies. In a short span of time, AJA has been able to attract many global companies as its partners in the region. General queries contact Faisal Bindail Deputy General Manager Business Development-Aja Pharma E-mail: info@ajapharma.com Address: PO Box 2665 Riyadh 11461- Kingdom of Saudi Arabia Tel: +966-11-268 7999 Fax: +966-11-268 7911

IPI Outsourcing & Innovation Supplement 2016


CDMO/CMO

Gerresheimer is a leading global partner … to the pharma and healthcare industry. With our specialty glass and plastic products, we con­ tribute to health and well­being. We have world­ wide operations and our 10,000 employees manufacture our products in local markets, close to our customers. With plants in Europe, North America, South America and Asia, we generate revenues of approximately EUR 1.4 billion. Our comprehensive product portfolio includes pharma­ ceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

Plastics & Devices The product portfolio of the Plastics & Devices Division includes complex, customer­specific products for the simple and safe administration of medicines, such as insulin pens, inhalers and prefillable syringes. Also included are diagnostics and medical technology products such as lancets and test systems, as well as pharmaceutical plastic containers for liquid and solid medicines with closure and safety systems. For the North American prescription retail market a complete line of regulatory compliant prescription containers for medication dispensing is available.

Our products are important and convenient

Primary Packaging Glass solutions for everyday life. 8 INTERNATIONAL PHARMACEUTICAL INDUSTRY

The Primary Packaging Glass Division produces glass primary packaging for medicines and cosmetics, such as pharma jars, ampoules, injection vials, cartridges, perfume flacons and cream jars. IPI Outsourcing & Innovation Supplement 2016


DumaÂŽ Twist-Off Protect US standard container now also available with the Protect features | Reduced moisture vapor transmission | Reduced oxygen permeability | Multiple choices for your needs

www.gerresheimer.com


CDMO/CMO

Therapure Biomanufacturing, a division of Therapure Biopharma, Inc. 2585 Meadowpine Blvd. Mississauga, Ontario, L5N 8H9, Canada Tel: +1905-286-6200 Fax: +1905-286-6300 Email: busdev@therapurebio.com Web: www.therapurebio.com/CDMO

VITAL STATISTICS

MAJOR MARKETS

Year Founded: 2008

• North America

Number of Employees: 400

• European Union

Key Personnel: Nicholas Green, President and Chief Executive Officer; Dirk Alkema, Vice President, Technical Operations; David Long, Chief Financial Officer; David Bell, D rug Development and Chief Scientific Officer ; Peter Dans, Chief Financial Officer; Brian Hadfield, Chief Manufacturing Officer.

WHO WE ARE Contract manufacturing of biologics is more than having superior technology—it’s having experienced people who are passionate, responsive and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated Contract Development and Manufacturing Organization (CDMO), Therapure Biomanufacturing, a division of Therapure Biopharma Inc., has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical and commercial). Our 136,000 ft2 (12,800m2) cGMP manufacturing facility meets FDA, EMA and HPFB regulatory standards and includes flexible clinical and commercial production suites.

10 INTERNATIONAL PHARMACEUTICAL INDUSTRY

SERVICES OFFERED Development: Cell Lines, Analytical Methods, Upstream and Downstream Processes cGMP Biomanufacturing From a Variety of Biological Sources, Including Mammalian Cell Culture, Plasma, Transgenic Sources Aseptic Fill/Finish – Vials, Prefi lled Syringes & Lyophilization Full Range of Quality Control Testing

WWW.THERAPUREBIO.COM/CDMO

IPI Outsourcing & Innovation Supplement 2016


Passion for your Process, Product and Patients

Development Services

cGMP Manufacturing

Aseptic Fill/Finish

Cell Line; Upstream; Downstream; Analytical

Upstream Production; Downstream Purification

Vials; Syringes; Lyophilization

Contract manufacturing of biologics is more than having superior technology – it’s having experienced people who are passionate, responsive and committed to developing and manufacturing your biotherapeutics to improve patient care.

We invite you to feel the difference at Therapure Biomanufacturing, where the client experience is our passion and patient care is our commitment.

Please visit us at

www.therapurebio.com/CDMO Or contact:

Dina Iezzi Director, Marketing & Special Projects Phone: +1 (905) 286-6270 Mobile: +1 (647) 234-3395 Email: diezzi@therapurebio.com Therapure Biomanufacturing, a division of Therapure Biopharma Inc. ©2017 Therapure Biopharma Inc. All rights reserved.


CDMO/CMO

A Strategic Partner Focused on your Success Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges and vials. We are a familyowned, independent company and do not manufacture our own drugs. Our focus is on providing highly skilled support and state-of-the-art manufacturing resources - from the initial phases of clinical development and regulatory approval process through successful product launch, commercial manufacturing, and life cycle management. Vetter Development Service Vetter Development Service helps smooth the path to clinic with dedicated support for development, testing, clinical manufacturing, and regulatory approval. We help you integrate thoughtful, efficient life cycle solutions for long-term growth and success.

Vetter Packaging Solutions There are many factors to consider in the selection of your primary and secondary packaging materials. Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle. We provide: • Customised packaging development • Specialised technologies • Proven platform technologies • Packaging services • Logistic services

We provide: • Formulation support • Process development • Clinical trial manufacturing • Analytical services • Regulatory support Vetter Commercial Manufacturing Vetter Commercial Manufacturing supports your injectable with more than 35 years of expertise in high-quality, state-of-the-art aseptic filling - and experience-based solutions that add value and increase efficiency.

Fast Facts: Vetter-at-a-glance • Headquarters in Ravensburg, Germany • Additional clinical development facility in Chicago, US • A Representative office for Asia Pacific in Singapore and a subsidiary in Japan • Approximately 3,900 employees • Worldwide specialist in the aseptic production of prefilled drug delivery systems • Global experience and expertise with regulatory authorities including FDA, EMA, PMDA(Japan), and RP (Germany), in multiple countries, including Canada, Russia, Brazil, Mexico, and Saudi Arabia • More than 35 customer products with FDA approval • Numerous patents including technologies for protection against tampering and counterfeiting • Lyophilization (freeze-drying) and siliconization specialist Contact For international inquiries please contact +49-751-3700-0 or info@vetter-pharma.com. For US inquiries please contact +1-847-581-6888 or infoUS@vetter-pharma.com. Visit www.vetter-pharma.com for more information.

We provide: • Fill and finish • Analytical services • Regulatory support • Product life cycle management 12 INTERNATIONAL PHARMACEUTICAL INDUSTRY

IPI Outsourcing & Innovation Supplement 2016


Do you know whom to trust with your complex compound? By the time your compound gets to clinical development, you’ve already invested years of painstaking work. Yet the next phase is filled with unpredictability and challenges. So what can you do to help smooth your compound’s path to clinic and beyond? With Vetter, you get the advantages of working with a partner who knows how to take your compound from preclinical to clinical to commercial manufacturing: ■

Expertise in the development of a broad range of drugs, including sensitive biologics

Technology, processes, and resources to achieve developmental milestones

Clinical manufacturing facilities in the US and Germany

When it comes to your injectable compound, turn to the partner trusted by top biopharmaceutical companies. Turn to Vetter.

Answers that work www.vetter-pharma.com US inquiries: infoUS@vetter-pharma.com • Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com • Japan inquiries: infoJapan@vetter-pharma.com • EU and other international inquiries: info@vetter-pharma.com


Chapter Title Packaging & Drug Delivery Nemera is a World Leader in the Design, Development and Manufacturing of Drug Delivery Solutions for Pharmaceutical, Biotechnology and Generics Industries. Nemera’s expertise covers five modes of delivery:

Ophthalmic Nemera offers a multidose closing tip system, Novelia®, which avoids the need for preservatives in the drug and prevents bacterial contamination over the duration of treatment. Novelia® is an innovative, user-friendly, preservative-free multidose eye dropper with a precision blue tip, which is commercialised for both medical devices and prescription drugs. It is recognised and appreciated by patients today across four continents. It is useful for applications for dry eyes, glaucoma, allergies and more. Nasal, Buccal, Auricular Nemera offers an extensive range of metered pumps and valves, compatible with a wide choice of actuators in different shapes and fitments for nasal, buccal and auricular delivery. SP270+ is the new optimised spray pump engine for ear, nose and throat in terms of performance and raw materials. Advancia®* offers a new alternative to improve treatment compliance in an increasingly demanding nasal spray market. Designed to be a step ahead of today’s pumps, Advancia® is based on a new system combining user-independence and anticlogging features in one single system. Parenteral Nemera leverages decades of manufacturing and development experience in the parenteral device segment to offer patients premium products and customers a complete service. Nemera has developed Safe’n’Sound®, a fully passive safety device for prefilled syringes to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medications, and individuals who assist self-injecting patients, from accidental needlesticks. Not only does Safe’n’Sound® improve users’ safety and injection conditions, but also the device complies with the recommendations of the World Health Organization and the EU Council Directive 2010/32/EU.

formulations to challenging dugs (viscous, sustain released, concentrated, in subcutaneous or intramuscular layers, in large volumes…) Dermal and Transdermal Nemera’s dermal delivery devices have been designed to ensure patient compliance thanks to precise and consistent dosing, which is critical, especially when applying formulations for systemic treatments. Sof’Bag® is a high-performing airless pouch system for dermal and transdermal applications. Sof’Airless XS is a protective mini-airless system for small-dose applications and sampling. Sof’Airless XL is a customised dispenser for higher dose applications. Pulmonary Consistency and reliability are critical for respiratory patients. Nemera has a recognised expertise in the development and manufacturing of respiratory drug delivery devices, such as dry powder inhalers (DPIs), pressurised metered dose inhalers (pMDIs) and dose counters. www.nemera.net For more information, contact us: information@nemera.net *The Advancia® innovative project is cofinanced by the European Union. Europe is committed in Normandy with the European Regional Development Fund (ERDF).

Nemera developed also Safelia®, a breakthrough technology of auto-injector. This new generation of two-step auto-injector for fluid and viscous injections has been designed to ease patient self-injection experience and to deliver, in glass syringes, fluid 14 INTERNATIONAL PHARMACEUTICAL INDUSTRY

IPI Outsourcing & Innovation Supplement 2016


Patient-focused drug delivery devices Drug Delivery Devices Innovative developments Customized solutions GMP contract manufacturing

www.nemera.net information@nemera.net Phone: +33 (0)4 74 94 06 54


Packaging & Drug Delivery

Excellence in Clinical Trial Outsourcing It is our molecule-to-market offering that ensures true speed to market for our global customer base. Our Services Include: • Pharmaceutical Manufacturing • Dosage Forms: Solid Oral, Powders, Liquids, Semi-solids, Creams, Gels and Ointments. • Pharmaceutical Development: Formulation Development, Scale-up and Stability Testing, Process Validation, Technology Transfer, Analytical Support Services • Clinical Manufacturing: Xcelodose Delivery for Earlyphase Development, Manufacture of Clinical Trial Supplies, Contained Manufacturing of Highly Potent products, Scaleup • Commercial Manufacturing: Large-scale Commercial Manufacturing, Contained Manufacturing of Highly Potent Products, Support Services Analytical Development Analytical Development and Testing, Stability Testing, Microbiological Testing and Import Testing for EU Requirements

PCI is an integrated full service provider and a trusted partner to leading companies in the global healthcare industry; we offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to commercial launch, delivering speed to market and commercial success for our customers. Core services include: analytical services, formulation development, clinical trial supply, commercial manufacturing and packaging, QP services, supply chain management, storage and distribution. Our customers can choose to use us as a complete development partner or use any of our core services on a stand-alone basis. Our aim is to provide solutions and challenge in a consultative way to identify and predict hurdles before they are reached. To achieve this, we demonstrate passion, energy and commitment to our task, which facilitates speed of customers’ products to market. Outstanding customer care is PCI’s primary goal and we continually strive for excellence in all our processes. Our commitment to investment in expansion and the latest technology has increased our offering and capacity for both current and future customers. Our exemplary regulatory record and export experience has enabled us to become the trusted European partner for many of the world’s top healthcare companies. Our reputation for providing secure and reliable advice on the importation and distribution of clinical trial and commercial products continues to grow, working with the major regulatory bodies in Europe, the USA, South America and Japan. 16 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Clinical Packaging and Labelling Primary Packaging, Secondary Packaging, Parenterals and Injectables Labelling, Device Assembly, Compliance Prompting and Child-resistant Packaging, Kitting, Overlabelling, blinding, randomisation and Expiry Date Extension Clinical Trial Logistics Global Storage and Distribution, Cold Chain and ATMP Management, Returns Management  Clinical Support Services Project Management, Protocol Interpretation, Comparator Product Procurement, Product Blinding, Label and Randomisation Generation, Translation Services, QP Services, Distribution and Logistics Planning, Package Design and Development, IVRS/ IWRS and Web Connectivity Commercial Packaging Primary and Secondary Packaging, Parenteral and Injectable Packaging, Compliance Prompting & Child Resistant Packaging, Kitting, Design and Package Development, Packaging for Highly Potent Products, Serialisation and Anti-Counterfeiting Solutions Working with PCI • Leading customer experience • Trusted and proven partner • Unparalleled expertise • Exemplary regulatory compliance • Best-in-class technologies

IPI Outsourcing & Innovation Supplement 2016


A Trusted Partner Expertise and Care in Clinical Development

PCI Clinical Trial Services Come experience what makes PCI different. We support clients as a true partner and extension of their business, offering expertise and experience guiding products to successful outcomes. With over 50 years experience, an integrated supply network to meet the needs of global studies, and an exemplary regulatory profile, we offer adaptable and innovative services to offer our clients real solutions enabling speed-to-market for their lifesaving medicines.

Expertise

Experience

Partnership

Clinical Services Manufacturing | Packaging & Labeling | Global Storage & Distribution

Commercial Services Manufacturing | Packaging | Serialization

www.pciservices.com Š Copyright 2015 Packaging Coordinators, Inc. All Rights Reserved


Packaging & Drug Delivery

Putting Life Into Technology Vital Stats: Founded in 1952. Employees: 800 Key Personnel: Jarl Severn, Managing Director Global market served. Who we are: Owen Mumford specialises in integrated design and build services from a broad range of self-injection platform devices for the pharmaceutical industry. From the first automatic lancing device to our patented selfinjection devices, with Owen Mumford you have access to unrivalled experience in designing, developing and delivering solutions to help you make adherence easier for patients. Device solutions With more than 30 years experience, your device is in good hands with Owen Mumford. From day one, we will guide you throughout the development process. At every step you will benefit from exceptional project management, quality processes, industrialisation and production for a smooth development and launch. Consultation We listen to your needs to determine the best solution, drawing on our experience of multiple primary containers, formulations and therapies. From simple brands of existing technology to wholly bespoke designs – we can help you achieve your goals. Design A multi-disciplinary team of professionally qualified experts ensures that design concepts meet your exact requirements. The thorough understanding of your end users’ needs includes the incorporation of human factors and ergonomics studies. Develop A close collaboration between design, production and your own team will ensure your device is designed for manufacture while still keeping patient satisfaction in mind. Deliver The production of your device is tailored to your needs – from low-volume hand assembly to high-volume automation. We are also licensed for the final assembly of combination products. Example of our new innovation are shown here...contact us for more information. UniSafe A springless passive safety device for pre-fillable syringes UniSafe is a springless, passive safety device designed to work with standard, pre-fillable syringes. This means nothing that 18 INTERNATIONAL PHARMACEUTICAL INDUSTRY

touches the drug needs to change. UniSafe looks and works like a normal syringe. Key features • UniSafe is designed without a spring, which means that the syringe barrel is unobscured, allowing the user to visually confirm the full dose has been delivered • Improved end-user comfort with a larger, ergonomic plunger head and a smoother, more integrated finger flange resulting in a more integrated look and feel • Prevention of accidental activation which can occur with traditional spring-based auto-injectors • Passive needle retraction means that the device is safe as soon as the plunger is fully depressed • Designed to work with standard, pre-fillable syringes • Autoject® Micro A true auto-injector with automatic needle insertion in a compact body Autoject® Micro is the next generation disposable auto-injector. Its compact design is the result of patented drive mechanism technology allowing true auto-injection in a more discreet package. This is designed to improve adherence by overcoming barriers to self-injection – whilst addressing your cold store and logistics costs. Autoject® Micro is a disposable device, which can either be supplied fully assembled with your prefilled syringe or delivered to you in separate parts ready for final assembly at your facilities. Key features • True auto-injection: needle is inserted and dose delivered at the touch of a button • Concealed needle to reduce injection anxiety • Sharps Injury Prevention: needle is hidden before and after use • Protective cap and locking mechanism prevent accidental activation • Activation button appears when device is unlocked and ready to use • Audible and visual feedback at start and end of dose • Convenient size for storage and portability • Intuitive: use as a press-button or contact-activated device • Large viewing window for easy viewing of syringe • Ergonomic: oval shape and large grip detail on cap Contact: Owen Mumford Ltd, Brook Hill, Woodstock, Oxfordshire OX20 1TU United Kingdom Tel: +44 1993 812021 Email: devicesolutions@owenmumford.com Web: www.omdevicesolutions.com

IPI Outsourcing & Innovation Supplement 2016


The experience we bring to you, matters to TOM

From the first automatic lancing device to our patented self-injection devices, with Owen Mumford you have access to unrivalled experience in designing, developing and delivering solutions to help make adherence easier for your patients... just like Tom. Find out more at omdevicesolutions.com or call +44 (0) 1993 812 021 PUTTING LIFE INTO TECHNOLOGY


Chapter Title Packaging & Drug Delivery

Respiratory Drug Delivery Devices is H&T Presspart’s Plasma Technology for pMDI cans, which enable customers to meet the most challenging requirements for formulations, compatibility and final product performance. The H&T Presspart Plasma Treatment improves the surface energy performance of an MDI canister, thus helping to prevent the active content of a drug formulation sticking to the canister wall. This ensures that the patient receives the prescribed dose and solves an inherent problem present within many of today’s metered dose inhalers. There’s also the added benefit of enhanced drug stability performance, in formulations where interactions with the aluminium substrate can lead to product degradation and reduced shelf life. H&T Presspart Manufacturing is the world’s leading supplier of respiratory drug delivery components, dose counters, dose indicators, and the first market-ready, fully connected MDI. H&T Presspart’s product portfolio includes deep-drawn aluminum and stainless steel metered-dose inhaler cans as well as precision plastic molded metered-dose inhaler actuators, dispensing actuators , multi component sub-assemblies and finished devices, predominantly for the respiratory drug delivery and medical device markets. Both the quality of the active ingredients and the reliability of the packaging and delivery systems are crucial to the health of patients. It’s H&T Presspart’s precision that makes all the difference here and that’s why it’s the company’s most important guiding principle. With more than 40 year’s expereince and a worldwide reputation for competence, quality an innovation in the manufacture of respiratory drug delivery components, it is easy to see why H&T Presspart are the partner of choice for some of the biggest names in the pharmaceutical industry. H&T Presspart’s world class manufacturing capability ensures high quality products to meet rigorous global customer and regulatory demands, as well as cost leadership through improvement programs. H&T Presspart is committed to continuous innovation, providing customers access to leading edge technologies and next generation solutions to meet their needs in an increasingly demanding global market. An example of this innovation 20 INTERNATIONAL PHARMACEUTICAL INDUSTRY

H&T Presspart in partnership with Cohero Health have also launched the first market-ready, intuitive, fully-embedded and connected metered dose inhaler (eMDI) aimed at improving adherence and enabling continually optimized care of patients with asthma and COPD. It is the only eMDI integrated seamlessly with BreatheSmart from Cohero Health, a comprehensive respiratory disease management platform that uniquely enables tracking of both controller and rescue medications, along with clinically accurate lung function measurement, in real-time. H&T Presspart’s has also developed the patented Quantum end of life indicator system for pMDIs. Quantum has been developed to be a low cost, disposable dose indicator solution, ensuring the patient doesn’t run out of their medication when they need it the most. Quantum is built in to the MDI canister by H&T Presspart, and is compatible with current filling and packaging lines. The Quantum dose indicator system also features no moving parts, ensuring the patient has a fail safe, robust and reliable end of life calibration system. As part of its commitment to innovation H&T Presspart have created an Inhalation Technology Centre (IPTC). Inhalation Product Technology Centre will deliver the capabilities to support new product developments, and strategic initiatives with our customers. H&T Presspart has an in depth technical understanding of the products we manufacture as well as assembly. IPTC will enhance those capabilities and deliver a customer focused device development and drug related performance understanding. H&T Presspart have manufacturing facilities in Germany, UK and Spain, and are part of the Heitkamp and Thurman Group, the leading global partners for the supply of world class precision formed components in both metal and plastic. With 19 medium sizes manufacturing companies, the Group performs services for the most demanding customers around the world.

IPI Outsourcing & Innovation Supplement 2016


Quantum Dose Indicator System

Now includes an interactive patient app

H&T Presspart, the world’s leading manufacturer of metered-dose inhaler canisters and actuators, has developed the Quantum end of life indicator system for MDI’s. Quantum has been developed to be a low cost, disposable MDI indicator solution, ensuring patients don’t run out of their medication when they need it most. Quantum also now features an interactive mobile app for patients to use in conjunction with the Quantum system to track their medication usage, even if the patient uses multiple inhalers.


Packaging & Drug Delivery

perfeXion™ The New Era of Quality Processing: Moving towards Zero Defects perfeXion™ The New Era of Quality Processing In quality control, details matter. When it comes to pharmaceutical primary packaging such as vials, cartridges or syringes, fluctuations in tubing dimensions such as the inner diameter or wall thickness can have a significant impact on the container performance – for instance, the filling or dosing accuracy for high potential drugs. Up until now, manufacturers of glass tubing have usually been monitoring quality parameters on a random sample base. SCHOTT, however, has developed a new production quality process called perfeXion™. perfeXion™ stands for the transition from statistical quality control to 100 % inspection of each individual FIOLAX® tube. Various interacting online inspection devices, in combination with integrated data collection and data analysis, allow quality parameters of the original tube to be adapted to the container format (syringe, cartridge, vial or ampoule) and customer specification. With this, SCHOTT aims to contributing to patients’ safety from the very beginning of the value chain. SCHOTT is a leading international technology group in the areas of speciality glass and glass-ceramics. With more than 130 years of outstanding development, materials and technology expertise, we offer a broad portfolio of highquality products and intelligent solutions that contribute to our customers’ success. Glass - The First Choice for Pharmaceutical Packaging Glass has many advantages over other packaging materials used for pharmaceutical primary packaging. It has only a few components, ensuring reliable information on the chemical resistance and protection of the medicines. Glass can be very

easily sterilised, it is absolutely impervious to gas, and has a good temperature resistance and withstands high inner pressure, especially when tubing glass is used for packaging. With a production capacity of more than 140,000 tons and production sites in Europe, South America and Asia, SCHOTT Tubing is one of the world’s leading manufacturers of glass tubes, rods and profiles. Approximately 60 glass types are produced in large external diameters and a variety of lengths based on site-overlapping strategies in development, production and quality assurance. SCHOTT Tubing provides customised products and services for international growth markets such as pharmaceuticals and electronics, as well as industrial and environmental engineering. Otto Schott brought the FIOLAX® glass tubing onto the market for manufacturers of small medicine bottles in 1911. He created a product that still satisfies the highest quality standards today. These provide a safe means of storing sensitive pharmaceuticals, generic drugs and modern biotech medicines, because highquality packaging is the only way to provide people safely with the drugs they need. For more information please contact: SCHOTT AG Erich-Schott-Straße 14 95666 Mitterteich Phone +49 (0)9633 80 0 Email: info.tubing@schott.com www.schott.com/tubing

perfeXion™ The New Era of Quality Processing Our aim: Zero defect. Documented for every single FIOLAX® tube. Seamlessly integrated data network.

100 % in-process-measurement with line scan and area cameras, laser, visible and IR inspection systems Every Single Tube NEW

Production Line

Inspection over entire tube length

Final 100 % Inspected Single Tube

Sorting

Sorting

Dimensional Features

Visual Features

Dimensional Features Visual Features

• • • •

• • • •

• • • •

Outside Diameter Wall Thickness NEW Siding NEW Inside Diameter NEW

Open Airlines NEW Closed Airlines / Seeds Knots Stones

Packing

Specific Area Inspection

NEW

Straightness Circularity Outside Diameter Square Cut

All measured single tube data are used for certification NEW

• Large Particles • Contamination • Tube ends

Quality data per pallet are also available in SCHOTTs e-commerce system

e-com

Process Control and Integrated Data Management System • Integrated network for real time collection and evaluation of all dimensional and visual glass quality and process data

• Storing more than 100.000 real-time data tags per minute

• Operational intelligence: Control and improvement of production process through Cp and CpK data

NEW

• PI database – proven and established in pharmaceutical industry. It is conform to FDA 21CFR Part 11 as well as with the most recently published ISO 15378 (GMP) standard

7Fgb21.11.2017LK

SHU_Grafik_perfeXion_process_englisch_final_v2.indd 2

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30.11.16 14:06

IPI Outsourcing & Innovation Supplement 2016


NEW SCHOTT perfeXionTM

The New Era of Quality Processing has already started! The transition from statistical quality control to 100 % realtime inspection of each individual FIOLAXŽ tube enables our customers to tailor dimensional and cosmetic quality of glass tubing to specific packaging requirements. What‘s your next milestone?

www.schott.com/perfexion

Pharmapack Paris, Hall 4 H89 Speech Dr. Folker Steden: Feb 1st 2017, 4.00 - 4.30 pm

SCHOTT AG, Tubing, info.tubing@schott.com, Phone +49 (0)9633/80-0


Logistics & Supply Chain

The Preferred European Pharma Gateway Belgium’s Key Markets Belgium is well-known for its large share of worldwide export and import for pharmaceuticals, perishables and automotive. Brussels Airport and its partners provide high-quality infrastructure and processes for these important market segments, such as temperature-controlled warehouses and GDP complaint handling procedures. Brussels Airport Located at the crossroads of Europe, Brussels Airport offers fast connections with other major airports and direct access to a dense road network. Central Location and Long Haul Brussels Airport is centrally located in the most important economic area of Europe, where 60% of GDP is done. Next to the existing operation of their full freighter airlines, Brussels Airport has seen fast growth in terms of long-haul flights, resulting in additional direct connections in their network. Major Full-freight and Distribution Hub Brussels Airport is an important cargo hub and a leading gateway for the transportation of pharmaceuticals and other time- and temperature-sensitive goods. Brussels Airport is the most strategic location in Europe, reflected by its role as a valued European distribution hub, an ideal location for storage, handling and shipping of high-value and time-sensitive products. A Trustworthy Operating Base Brussels Airport is characterised by a proven coordinated approach between all involved partners, resulting in an efficient inbound and outbound cargo process. At Brussels Airport, the handling companies provide specialised services for nichemarket handling: • • • • • •

Pharmaceuticals High-value goods Live animals Perishables Dangerous goods Outsized cargo

4 innovations at Brussels Airport: From idea to implementation: 1. World’s First CEIV Pharma-certified Airport Community For reliable and transparent transportation of your pharmaceuticals, Brussels Airport is your ideal partner, with the highest concentration of CEIV Pharma-certified companies and specialised staff in Europe. You have a choice of CEIV Pharmacertified partners and regulator-approved partners at Brussels Airport for fast, reliable, safe and secure handling of your pharmaceuticals.

products between storehouses and aircraft on the tarmac. The “airside pharma transporter” is a trailer on which an insulated cool box is installed. What is really innovative is the technology that allows the temperature and location of the refrigerated transporter to be monitored in real time. 3. A Community-driven Approach Brussels Airport stimulates the cargo community by supporting a platform where all stakeholders at Brussels Airport can lobby, network, organise trainings, etc. This platform, named Air Cargo Belgium, is unique and offers great value to the cargo community and increases the efficiency of the air cargo chain. 4. Cloud-based cargo community platform Brussels Airport is also working on a cloud-based cargo community platform based on big data management: BRUcloud. BRUcloud will offer logistical solutions like statistics, slot and gate management, pharma shipment dashboard via different easy-to-use apps.

2. The Airside Pharma Transporter Bringing the unbroken cool chain to the next level, Brussels Airport has developed the “airside pharma transporter” - an innovative, own invention. This refrigerated transporter is especially designedned for the transport of temperature-sensitive 24 INTERNATIONAL PHARMACEUTICAL INDUSTRY

IPI Outsourcing & Innovation Supplement 2016


Logistics & Supply Chain

Pharmaceutical Transport Taken to New Heights healthcare products shipments. All of our temperature-controlled storage units are monitored for temperature and humidity levels via an online tracking system. All Turkish Cargo staff that are involved in the transporting of cargoes participate in international and in-house training and certification programmes. Such training is carried out in accordance with the regulations established by the Directorate General of Civil Aviation and standards specified in the IATA Airport Handling Manual. In addition to this training provided by related companies, we also provide refresher training. To prevent our cargoes from being exposed to often changing temperatures during flights, we use active temperature-controlled containers. In containers which contain highly-sensitive cargoes such as healthcare products, vaccine, insulin and cancer drugs, we manage to maintain the desired temperatures even during long-distance flights. With our data entry log, we also report to our customers about the changes in temperature of their shipments during the whole transportation process. Thanks to the agreements we’ve made with international container supplier Envirotainer, we can realise shipments between -20°C and +25°C at the demanded circumstance and capacity. Turkish Cargo has been carrying out its operations of transporting and storing drugs and temperature-sensitive healthcare products successfully. We carry out our cargo operations in line with special schedules established for cold chain logistics and ensure the punctual transport of these supplies, sent via passenger or cargo flights, to over 100 countries around the world. Turkish Cargo’s cold chain logistics are prepared specifically in order to protect the contents and prevent them from deterioration. All healthcare products requests made to Turkish Airlines, verbally or on paper, are handled by our offices, general sales agencies and Cargo Reservation Department. In the acceptance stage, cargoes are examined and categorised by our Cargo & Document Acceptance Unit, according to their destinations, types, weight, amount and size. At the acceptance stage, all transportation of drugs and healthcare products are executed in accordance with the IATA Acceptance Checklist. At the reservation stage, the shipments are assessed for safety, portability and packaging in accordance with aircraft type, country regulations, Turkish Airlines embargoes, international regulations, IATA regulations and the IATA Airport Handling Handbook. Later, the cargo that passes these assessments is accepted through special delivery doors dedicated to healthcare products shipments and located close to X-ray scanners. All transportation of healthcare products is executed in accordance with IATA regulations. We offer our customers various services including temperature-controlled active and passive systems. Our new cargo terminal comprises an over3000m2 special storage area and 39 separate special cargo rooms which have high quality standards, including temperaturecontrolled storage units designated for drug, vaccine and 26 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Active container demands of our customers are assessed by our expert teams in our Special Cargo Directorate. On request, our containers are installed with a temperature setting by our certified experts and delivered to our clients ready to be loaded to the plane. After the acceptance of the container, it is carried into the active container storage area at our facility. The temperature and battery charge is monitored in designated periods according to instructions given in Active Container Regulations. The temperature and battery charge of the container is constantly monitored until its delivery to the recipient. IATA CEIV Pharma certification is recognised as one of the important indicators of our process for pharmaceuticals shipments. We have successfully completed the IATA CEIV Pharma Certification at this time. During this period of time, we revised each step of the process in order to ensure high levels of reliability and security throughout shipment. By being certified by IATA CEIV Pharma, Istanbul Cargo Hub is fully compliant with all applicable pharmaceutical standards. At Turkish Cargo, we’ll continue to provide technology-driven logistics solutions to individual customers and major corporations. We’ll work to make Istanbul one of the biggest players in the air cargo trade between East and West, benefitting from its strategic location at the centre of world trade routes.

IPI Outsourcing & Innovation Supplement 2016


Logistics & Supply Chain

Supply Chains in a Digital Age

How the digital revolution changes the way we think about logistics The global economy is witnessing significant and rapid change, thanks to major technological advances over the last decade. The German news portal Spiegel Online noted a societal transformation “that can only be compared with 19th century industrialisation, but it is happening much faster this time . . . the digital revolution isn’t just altering specific sectors of the economy, it is changing the way we think and live.” Ubiquitous mobile connectivity combined with data gathering and analytics will drive the emergence of new services, products and business models in all industries. It’s also changing the way we think about logistics. Indeed, this digital revolution has led to huge growth in areas such as e-commerce, global collaborative research, development and manufacturing, as well as in logistics. There will be more to come – ubiquitous mobile connectivity combined with data gathering and analytics will drive the emergence of new services, products and business models in all industries – including healthcare, energy, finance and government. Dozens of companies are even trying to invent the future too, looking at how to use drones, for data collection, for last mile deliveries, or for other purposes. When it comes to supply chain management, such rapid advances are forcing organisations to constantly re-evaluate their networks, and use digital technology to significantly enhance their services. One driver of this demand for supply chain re-design is e-commerce. In order to meet customers’ growing appetites for online purchasing, retailers look for ways to support e-commerce growth. Customers expect top-class service levels, with same day

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or next day delivery services, so online retailing always needs to look at improving the customer experience. Strategic changes can also trigger the need to review the entire supply chain infrastructure – for example with new company acquisitions or mergers, or market expansion. In some cases, financial and operational demands drive the need for change – if efficiency and cost savings are being sought, or the network might have become too complex, or parts of it become redundant, due to growth or consolidation. When it comes to supply chain management, rapid advances are forcing organisations to constantly re-evaluate their networks. Whatever the case, the organisation needs to analyse its supply chain and move it to an efficient cost versus service level tradeoff – often to reduce or optimise total logistics cost, comprising transportation, service, inventory and facilities. Effective supply chain management can reduce total logistics cost by up to five percent – and also impact profit to the equivalent of up to 30 percent increase in sales, according to a UPS analysis. Criteria for building an optimized network When a company decides to undergo a complete network redesign or an optimisation, the tried and tested approach is to first determine the project scope, with requirements, resources, project plan, and importantly, a timeline. The plan should evaluate the pros and cons between having an owned network versus using a 3PL provider. An in-house network might provide complete freedom and flexibility, but has complexity, cost and risk associated with it; meanwhile a 3PL might help bring scale which one’s own network might never be able to provide, at lower cost and potentially greater service levels.

IPI IPI Outsourcing Outsourcing & & Innovation Innovation Supplement Supplement 2015 2016


Logistics & Supply Chain

percent, while a seven DC scenario the total supply chain cost would be reduced by 39 percent. While one appeared to offer greater cost savings overall, there were trade-offs – in the three DC scenario, 1-day service decreased 22 percent, but 2-day service increased 131 percent; in the seven DC model, 1-day service increased 44 percent and 2-day service increased 42 percent. Both scenarios were better than the baseline in terms of service and cost, but involved trade-offs. In the end, this customer prioritized the tree DC scenario as a 2-day shipping service satisfied the company’s customers service level commitments.

In designing and building an optimised network, the key criteria to consider include sourcing, manufacturing, distribution, delivery, fulfilment and returns. For example, this would include the number of site locations, transportation and alternative modes, warehouse design, route optimisation and business processes. Sustainability and visibility are also important – particularly factors like carbon footprints, carbon neutral shipping, and end-to-end supply chain visibility, web integration and billing solutions. The next step is to analyse the parties that touch the network – the suppliers, the manufacturers, the distribution centres and the customers: • • •

Suppliers – how many raw material suppliers are there? Where are they located? What products are sourced? Manufacturing and distribution – how many manufacturing and distribution facilities are there? Where are they located? Which products are manufactured, in what quantities? Customers – how many customers are there? Where are they located? How are they served and where should they be served from? How do you handle the returns process with high levels of customer satisfaction?

Summary: the importance of adapting to rapid change The dynamics of the modern digital age mean that businesses need to adapt quickly. Logistics and supply chain networks are increasingly being put under pressure to deliver to more complex networks due to globalisation and higher expectations regarding service levels. In order to achieve this cost-effectively, digital technology, smart network design, and optimisation are key to a company’s success in a rapidly changing world.

Let’s look at one specific example. A pharmaceutical company with 19 distribution centres (DC’s), primarily in Western Europe, experienced significant network redundancies as it grew through acquisitions. Additionally, some key markets were underserved and had a high cost to serve. The dynamics of the modern digital age mean that businesses need to adapt quickly. Teaming up with a logistics expert, its network baseline parameters were calculated — looking at service levels, total weight shipped per zone, average distance shipped, operating costs, inventory levels and costs, and total shipping costs for all modes. As part of the network design process and “what if” planning, multiple scenarios were developed. In a three DC scenario, total supply chain cost would be reduced by 42 29 31 INTERNATIONAL INTERNATIONAL PHARMACEUTICAL PHARMACEUTICAL INDUSTRY INDUSTRY

Mark Jackson is Vice President, Contract Logistics Solutions, UPS Europe.

IPI IPI Outsourcing Outsourcing & & Innovation Innovation Supplement Supplement 2016 2015


Products & Equipment

Manufacturer of Assembly and Testing Solution Mikron Automation is a world leader in automation solutions for assembled products you can hold in your hand. Its mission is to deliver the most reliable, precise and productive assembly solutions to keep its customers one step ahead of the competition. Renowned companies around the world place their trust in Mikron – for precision, performance and success. Grown from the same roots as the Swiss watch-making industry, the story of Mikron Automation starts at the beginning of the 20th century with the foundation of Haesler, a company specialising in the construction of machining systems for the watch industry. Following its takeover by Mikron in 1961, the company began producing its first assembly systems back in 1976. Since 1991, the Mikron Automation division has focused completely on assembly automation. It has over 40 years’ experience and 3000 installations, with a long history of delivering successful customised automation solutions and it also has the crucial advantage of being close to its clients, wherever they are. We serve global customers in different markets: Pharma/ medical devices, automotive, electric/electronics, industrial/ building and consumer goods. Mikron Automation: The Assembly Solution for Pharmaceutical and Medical Devices Mikron Automation continuously innovates to supply the best automated assembly and testing solutions for devices such as inhalers, safety syringes, pen injectors, auto-injectors, e-devices, test and diagnostic kits, lancets and pumps. Mikron Automation is a leading manufacturer of customised, highly productive automation solutions for high-precision assembly and testing from the pilot line up to the automatic line. Mikron’s core competencies are the use of highly standardised manual, semi-automatic and fully automatic modules through its Mikron G05 and Mikron EcoLine platforms and its expertise in complex process integration. Mikron adds value with the use of Polyfeed, the flexible feeding system, and the Tray Handler, for loading and unloading parts from trays. The solutions operate at speeds of up to 100 cycles/minute with outputs from four up to 400 parts/minute. The entire family of Mikron products takes into account the special conditions for cleanroom ISO 7 (class 10,000) applications. The basic machine hardware and software is pre-validated to GAMP 5 and 21 CFR 21, part 11 standards. Pharma and Medical Competencies The pharmaceutical and medical device industries are governed by exceptionally stringent regulations and production processes which need to be verified by means of strict procedures. To meet these specific needs, Mikron offers full qualification support in accordance with GAMP-5. Specific emphasis has been put on 30 INTERNATIONAL PHARMACEUTICAL INDUSTRY

ergonomics and cleaning of tooling to meet the GMP norms. Mikron produces a set of documentation to support the customers in their validation process. On each site, Mikron has a dedicated and skilled team with medical project expertise to support the project team from design to delivery. Customer Service After installation, our customised training and production assistance introduces your people to the feel and function of the new system. This accelerates your productivity increases by reducing the personnel learning curve. Our support continues with remote maintenance tools, a service hotline, and the expertise of our technicians who arrive at your site to personally provide support throughout the entire service life of your assembly solution. These Specific Medical Customers Trust Mikron (Due to confidentiality, we cannot show an exhaustive list of our customers.) 3M Health Care, Aerogen, Alere, ARaymond Life, Bausch & Lomb, B. Braun Medical, Bang & Olufsen Medicom, Bespak/ Consort Medical plc, Aptar Group, Eli Lilly and Company, Forteq, Gerresheimer, GlaxoSmithKline, Innovata Biomed, Molex, Novo Nordisk, Nemera, Nypro, Oechsler, Pfizer, Schott, Sanofi, Tech Group, Teva Pharmaceuticals, Vygon, Ypsomed At a Glance • Mikron Automation is a leading global manufacturer of automation solutions for cost-efficient manufacturing of products in high quantities • Worldwide presence to support our clients locally • Facilities in Boudry (Switzerland, headquarters), Berlin (Germany), Denver (USA), Singapore and Shanghai (China) • 580 employees • CHF 116 million in annual sales revenue (2015) • 40 years of experience • 250 customers worldwide • 3000 installed systems • Over 50 projects a year • Four to 12 months delivery time • Every day 150,000,000 components are assembled on Mikron solutions Company Name: Mikron Automation Address: route du Vignoble 17 / 2017 Boudry / Switzerland Tel: +41 32 843 11 11 Fax: +41 32 843 11 12 Web: www.mikron.com/automation Key Contact: Jean-François Bauer / Head of Marketing & Business Development Mikron Automation Email: mbo@mikron.com

IPI Outsourcing & Innovation Supplement 2016


THE AUTOMATION SOLUTION

40 YEARS OF DELIVERING HIGH PERFORMANCE ASSEMBLY AND TESTING SOLUTIONS FOR DISPOSABLE PHARMACEUTICAL AND MEDICAL DEVICES.

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IPI Outsourcing & Innovation Supplement 2016


Outsourcing Overview

Outsourcing Overview This year IPI conducted an Outsourcing Survey, with over 400 professionals from the Pharmaceutical and Contract Services Industry. Forty-two percent of respondents were from pharmaceutical sponsor companies, and the remaining 58% represented service providers. When asked if there is an increasing demand for outsourcing this year, 73% of respondents answered yes. The number one reason for this, according to 41% of respondents, is to focus on core competencies. Pharmaceutical company sponsors say they are also outsourcing more because they are virtual (30%), while a significant number say they lack the capabilities in-house (14%). Sponsors say they are also using contract service providers as secondary suppliers, with 46% saying they are using them for APIs, 39% for commercial supply, 37% for clinical materials. Twenty-three percent say they are not using providers for any secondary supplies. Sponsor companies report they are continuing to take strategic (50%), as well as tactical (50%), or case-by-case, project-toproject approaches to outsourcing. Change is not likely in the wind as most (74%) are planning to continue this approach. In addition, 80% of sponsor company respondents this year say that they view contract relationships as partnerships. Preferred vendor lists have become less important for respondents this year; roughly 33% of sponsor company respondents say that more than half of their outsourcing budget currently goes to preferred vendors, which is down from 38% last year. Mid-sized and big pharma companies were tied, leading the pack in terms of seeking service providers (17%) followed by generic pharma (13%); specialty pharma (11%); consumer/OTC (10%); and big biopharma (9%). Despite growth in outsourcing, both sponsors and service providers point out ongoing challenges in outsourcing relationships. The top issue continues to be communication and culture. One respondent from the sponsor side said, “Only commit to what you can deliver with quality and integrity. Do a good due diligence of the scope of work, maintain transparency and communicate.” Fifty-one percent of respondents this year cited this as the top challenge of the sponsor-contract services relationship, which was down from 46% last year. Hopefully this is not a sign that communication paths are getting cloudier. Documentation and vendor qualification/selection were tied for the next top challenge cited (34%) followed by quality assurance (25%), scale up and scale down (24%), and regulatory issues, quality control and technology (19%). From the service providers’ perspective the top challenges cited when working with pharmaceutical companies are unrealistic deadlines (69%), insufficient information (67%), infrequent communication (41%), incomplete technology platforms (35%), and inadequate tech support (28%). For many drug manufacturers, innovation strategy involves streamlining an increasingly complex manufacturing system. This type of next-generation innovation wades through the growing sea of new ideas and emerges with the strategies that deliver a clear, focused value. How does this play out in pharma in 2016? In the form of targeted acquisitions and partnerships, personalized treatments, efficient outsourcing partners and properly integrated technologies. Consolidation has typically been a dirty word in pharma and rarely appears in the same sentence as innovation. But a handful of forward-thinking companies are recognizing the need to innovate beyond merely acquiring new molecule formulations. Dwindling (though definitely not gone) are the days when pharmaceutical companies would hunt for deals to boost up specific therapeutic areas, aiming to completely dominate that space. Under immense pressure to optimize performance, today’s companies are taking a heavy look at the systems and services behind these new drugs and making strategic acquisitions with an eye toward innovative services and digital technology. The last few years have seen numerous innovative crossovers as pharma looks toward unconventional partnerships, specifically in the tech field. In 2014, Google’s R&D business, Calico, partnered with AbbVie to focus on age-related diseases. Around the same time, Google X Labs teamed with Novartis to develop glucose monitoring, smart contact lenses and early last year, partnered with Biogen to explore wearables technology in multiple sclerosis. As their goal is to serve the unmet needs of the pharmaceutical and biotech industries, contract manufacturing movements are often reflective of the drug industry demands. Like the industries it serves, the contract services market has not been immune to consolidation. About 30 CMOs account for more than half of the industry’s revenues and, in the last three years, there have been 18 acquisitions in the CMO space. Despite a reduction in supplier options, pharmaceutical manufacturers are becoming smarter and more specific when it comes to choosing contract manufacturing partners, expecting a higher degree of flexibility. As pharmaceutical companies ramp up investment in flexible in-house technologies and continue acquiring their own contract services providers, contract manufacturers are understanding the need to specialize — especially surrounding the growth of biologic drugs and biosimilars, including the growing demand for novel therapies. CMOs are increasing their investments in single-use technologies for biopharmaceutical manufacturing and continuous manufacturing processes. Aware of their critical role in an increasingly sophisticated global supply chain, today’s contract manufacturers are innovating to provide high quality, flexible production.

32 INTERNATIONAL PHARMACEUTICAL INDUSTRY

IPI Outsourcing & Innovation Supplement 2016


Do you know whom to trust with your complex compound? By the time your compound gets to clinical development, you’ve already invested years of painstaking work. Yet the next phase is filled with unpredictability and challenges. So what can you do to help smooth your compound’s path to clinic and beyond? With Vetter, you get the advantages of working with a partner who knows how to take your compound from preclinical to clinical to commercial manufacturing: ■

Expertise in the development of a broad range of drugs, including sensitive biologics

Technology, processes, and resources to achieve developmental milestones

Clinical manufacturing facilities in the US and Germany

When it comes to your injectable compound, turn to the partner trusted by top biopharmaceutical companies. Turn to Vetter.

Answers that work www.vetter-pharma.com US inquiries: infoUS@vetter-pharma.com • Asia Pacific inquiries: infoAsiaPacific@vetter-pharma.com • Japan inquiries: infoJapan@vetter-pharma.com • EU and other international inquiries: info@vetter-pharma.com


IPI - Outsourcing Supplement 2016/17  
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