“Discovery consists of seeing what everyone has seen and thinking what nobody has thought”
PHARM Connect Congress Warsaw | 17-18 May 2022 | Warsaw Marriott Hotel
Albert Szent-Györgyi (1893-1986), Biochemist & Nobel Prize Winner for Medicine in 1937
2022
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CONTENT
17 - 18 May 2022 | www.pharmconnect.eu
Content Welcome Letter Floor Plan Conference Programme Speaker Biographies Plant Excursion Vendor Profiles Product Listing Media Partners CEE Pharmaceutical Manufacturing Excellence Award
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SPONSORS & PARTNERS OF PHARM CONNECT 2022
AMBER SPONSOR
COFFEE SPONSOR
PL ANT EXCURSION PARTNER
Organiser
The Events Group (TEG) is one of Europe’s leading business information providers. With two main services, business-to-business congresses, and professional trainings, we primarily focus on the key emerging markets in Central & Eastern Europe. Our unique business-to-business congresses bring together senior-level executives from Europe’s largest organisations with a select and diverse group of cutting-edge suppliers. Strictly operating on an invitation-only basis guarantees the highest level of delegate is present. www.tegevents.eu | info@tegevents.eu
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EXCELLENCE SOLUTIONS
Welcome to the World of Process Analytics
ORP
Cond
DO TCD
Cell Density VCD
Hamilton Bonaduz AG CH-7402 Bonaduz, Switzerland contact.pa.ch@hamilton.ch www.hamiltoncompany.com
pH
CO2
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WELCOME
17 - 18 May 2022 | www.pharmconnect.eu
Welcome ... to the PHARM Connect Congress 2022! On behalf of TEG, we welcome you to the annual PHARM Connect Congress 2022, one of the largest pharmaceutical and biotechnology manufacturing events and the only regional one for Central and Eastern Europe in 2022. The quality of the Congress is a direct result of its exclusivity. We have worked closely together with our programme advisory committee, leading local and regional associations and well-respected European and international media partners to ensure the event is of the highest quality and to guarantee its regional scope. The Congress has been tailor-made for senior industry professionals to provide them with a platform which offers the most up-to-date market insights into R&D, production, engineering, logistics, purchasing and quality management-related topics along with innovative product and service presentations offered by leading local and international solution providers. We are confident that our focused and targeted congress model will be a catalyst for your business success in one of the fastest-growing European regions in the pharmaceutical and biotechnology industries. Furthermore, we trust the PHARM Connect Congress will offer you the ideal networking opportunity to catch up on the latest developments and trends in your industry. The TEG team wishes you a rewarding and fulfilling two days at the PHARM Connect Congress 2022 in Warsaw and we look forward to seeing you again at future TEG events.
Dennis Lantos
Katy Säurich
Managing Director The Events Group
Head of Operations & Production The Events Group
PHARM Connect Congress 2022
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17 - 18 May 2022 | www.pharmconnect.eu
3rd floor – Conference Area 7th Central & Eastern European Pharmaceutical Manufacturing Excellence Award Ceremony 17th May 2022 | 17:15
Lifts
Terrace
Lunch Area Conference Room Baltic Ballroom Escalator
2nd floor – Exhibition Area
Floor no. 2 Lunch Area
Lifts
Registration
Grand Ballroom Cloakroom
Grand Ballroom Foyer
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EXHIBITION AREA
17 - 18 May 2022 | www.pharmconnect.eu
Exhibiton Area 2nd floor – Grand Ballroom Hamilton Bonaduz
Körber Pharma Software
Raumedic
Veltek Fette Associates Compacting
Selvita
Tive Endress+ Hauser
CRYOPDP
Antares Vision Group
Italvacuum Bonfiglioli Engineering
Röchling Kingspan Medical
B&P
Engineering
Registration
Grand Ballroom
cargopartner
Francelab / Actini / Sofast
Escalator Cloakroom
Registration
Grand Ballroom
Exhibiton Area 2nd floor – Grand Ballroom Foyer
SoftGroup
Coffee Lounge
ZETA
Introl
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Technobis Crystallization VIMACHEM Systems
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CONFERENCE PROGRAMME
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DAY 1 | TUESDAY, MAY 17 th 09:00
Doors open and event registration begins
09:30-09:40
TEG WELCOME ADDRESS:
Katy Säurich, Head of Production & Operations, TEG The Events Group Chairman’s Opening Address: Dr. Marten Ritz, Head of Global Projects | Operational Excellence, Production Networks, Smart Manufacturing at the Institute of Technology Management, University of St.Gallen, Switzerland 09:40-10:20
KEYNOTE OPENING PRESENTATION:
From Quality Metrics to Quality Management Maturity – Insights from the St.Gallen/ US FDA collaboration • How to operationalise Plant Performance and Maturity • Linking OPEX Implementation to Performance • Sustaining OPEX programmes over time • An outlook on the future of regulatory surveillance Dr. Marten Ritz, Head of Global Projects | Operational Excellence, Production Networks, Smart Manufacturing at the Institute of Technology Management, University of St.Gallen, Switzerland 10:20-10:40
Networking and Vendor Viewing
10:40-11:20
CASE-STUDY PRESENTATION:
Smart PAT – Shifting Quality Control to the Shop-Floor • New real-time measurement technologies that overcome the challenges of durability, specificity, and speed to measure PAT Critical Process Parameters and Key Performance Indicators during the process • Progressing digitalization to enable innovative process analytics (soft sensors), advanced process control (e.g. digital twin simulation), preventative maintenance, and asset management Giovanni Campologno, eMBA, Biopharma Segment Manager, Hamilton Bonaduz AG 11:20-11:40
Networking and Vendor Viewing
11:40-12:20
CASE-STUDY PRESENTATION:
The Road to Industry 4.0 in Novartis Technical Operations Poland • Novartis’s path towards Industry 4.0 • Cultural aspects: commitment, curiosity and process of continuous improvement • Long-term strategy in different areas of our company • Example of tools for automation and digitalization in our factory Przemyslaw Wierzbicki, Project Engineer & Head of Continuous Improvement at Packaging Plant, Novartis 12:20-13:20
Lunch and Vendor Viewing
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13:20-14:00
CASE-STUDY PRESENTATION: Live Processes Around Electronic Batch Records (EBR)
Implementation of EBR and the surrounding processes in the production area Key conclusions from the implementation - expectations versus reality Quality assurance expectations and the production area perspective – stuck in the middle • The batch release challenges caused by the implementation of EBR – laziness is the key to success Błażej Różański, Senior Production Systems Specialist, Department of Manufacturing Science & Technology, Polpharma • • •
14:00-14:20
Networking and Vendor Viewing
14:20-15:00
CASE-STUDY PRESENTATION:
Factory-of-the-Future: How Digital Shapes the New Ways of Working at Takeda • Usage of automation, data and digital tools to reduce bottlenecks, increase capacity and improve the quality of our manufacturing network • Impact of use of digital tools and robots on people’s capabilities and how they can shift their focus on value adding tasks Roland Straub, Global Head of Digital Supply Chain, Takeda Pharmaceuticals International 15:00-15:20
Networking and Vendor Viewing
15:20-16:00
PANEL DISCUSSION: How to Increase the Flexibility & Reliability of the Supply Chain
Lessons learned from COVID-19 and how to react in the future – Are we prepared for future outbreaks? • Be ready for fast & flexible solutions – Manage disruptions – Ready for constant change • Impact on Supply Chains due to Russian war against Ukraine, following global sanction against Russia and Belarus, and voluntary exodus of many international companies from Russia • Remote working – Ways of working in the future, esp. which pharma roles can be done remotely in the future and how? • Chance for CEE pharma manufacturers to fill the existing vacuum / gap István Király, Managing Director, HUMAN BioPlazma, Kedrion Biopharma Roland Straub, Global Head of Digital Supply Chain, Takeda Pharmaceuticals International Ana Dzaleva, Sourcing Manager, ALKALOID •
16:00-16:20
Networking and Vendor Viewing
16:20-17:00
CLOSING KEYNOTE PRESENTATION: Bringing the Real Value from Digital Solutions for Industrial Operations & Quality in Polpharma
Polpharma’s journey to embed digital solutions in business processes – from hype to rational • Usage of Internet of Things, Virtual & Augmented Reality to support business processes and bring real value to the organization Łukasz Krause, Group CIO, Polpharma Group •
17:15
AWARD CEREMONY OF THE 7TH CEE PHARMACEUTICAL MANUFACTURING EXCELLENCE AWARD & COCKTAIL RECEPTION
Welcome Speech by Dr. habil. Tamás Sovány, associate professor, Institute of Pharmaceutical Technology and Regulatory Affairs and Vice Dean for Education, Faculty of Pharmacy at the University of Szeged, Hungary PHARM Connect Congress 2022
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DAY 2 | WEDNESDAY, MAY 18 th 09:00
Door opening
09:30-10:10
CHAIRMAN’S KEYNOTE OPENING PRESENTATION:
Strategies & Benefits to Deploy Digital Twins along the Product Life Cycle • Generic workflows to generate and adapt hybrid digital twins for biopharmaceutical processes • Deployment of digital twins at different unit operations but also along the integrated process chain • The benefits of this approach are: Robust control strategies for accelerated stage 1 and stage 3 process validation as well as prediction of process event to optimise productivity at consistent product quality Prof. Dr. Christoph Herwig, Head of Research Group: Bioprocess Technology, Institute of Chemical Engineering, Vienna University of Technology, Austria 10:10-10:30
Networking and Vendor Viewing
10:30-11:10
CASE-STUDY PRESENTATION:
Smart Target Selection to Enable a Personalized Medicine Approach & Optimise Clinical Development • Personalized medicine and companion diagnostics • Treatment of IgA-mediated autoimmune diseases • Selection of antagonist anti-CD89 • IgA Rheumatoid Arthritis as new disease Dr. Louis Boon, CSO & Management Board Member, JJP Biologics & Principal Scientific Advisor, Polpharma Biologics 11:10-11:30
Networking and Vendor Viewing PRESENTATIONS OF AWARD WINNERS OF THE 7TH CEE PHARMACEUTICAL MANUFACTURING EXCELLENCE AWARD
11:30-11:50 11:50-12:10
1. Winner in the manufacturer category 2. Winner in the solution provider category
12:10-13:10
Lunch and Vendor Viewing
13:10-13:50
CASE-STUDY PRESENTATION:
ICH M7 Assessment & Control of Mutagenic Impurities in Pharmaceuticals to Limit Risks • ICH QM7 guideline content, purpose and applicability • Impurities assessment, risk characterization with special focus on nitrosamines impurities • Ways of mutagenic impurities control • Lessons learned from ‘sartans case‘ Dr. Piotr Lipiński, Global Quality Auditor, Audit & Compliance, Europe II, Novartis Technical Operations Quality
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CONFERENCE PROGRAMME 17 - 18 May 2022 | www.pharmconnect.eu
13:50-14:10
Networking and Vendor Viewing
14:10-14:50
PANEL DISCUSSION:
Nitrosamines & Mutagenic Impurities – Challenges & Lessons learned from the Valsartan Case Dr. Piotr Lipiński, Global Quality Auditor, Audit & Compliance, Europe II, Novartis Technical Operations Quality Oksana Makeienko, Quality Assurance Change Manager, Arterium Marta Smolarczyk, Global Supplier Quality Auditor, Fagron 14:50-15:10
Networking and Vendor Viewing
15:10-15:50
CASE-STUDY PRESENTATION:
Product Life Cycle Management – Change Production Gx Mainset • New challenges ahead of the production of generic drugs • OPEX cost reduction – Opportunities • Campaign production – Changing batch mindset • Continuous process • Industry 4.0 Przemysław Młynarczyk, Senior Process & OPEX Expert & Łukasz Lipiński, Junior Process Expert, Novartis 15:50-16:00
CHAIRMAN’S CLOSING REMARKS
Prof. Dr. Christoph Herwig, Head of Research Group: Bioprocess Technology, Institute of Chemical Engineering, Vienna University of Technology, Austria
In order to access PHARM Connect 2022 presentations please visit:
www.pharmconnect.eu/en/postevent
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Solutions for life Pharma Fluid Handling We are development partner of the international medical technology and pharmaceutical industry. Let´s find out how you can profit from our expertise! Come and meet us at our networking area.
raumedic.com
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SPEAKER BIOGRAPHIES 17 - 18 May 2022 | www.pharmconnect.eu
DAY 1 | CHAIRPERSON Dr. Marten Ritz DAY 2 | CHAIRPERSON Head of Global Projects | Operational Excellence, Production Networks, Smart Manufacturing at the Institute of Technology Management, St. Gallen University, Switzerland
Dr. Marten Ritz is overseeing three research groups in the fields Operational Excellence, Global Production Networks and Smart Manufacturing at the Institute of Technology Management, University of St. Gallen, Switzerland. He joined the institute in 2018 and is responsible for the global industry projects across Asia, Europe and the US. As the former head of the Operational Excellence research team, he brings extensive experience: Marten has supported numerous pharmaceutical companies in continuously improving operations in manufacturing areas and laboratories. Furthermore, he supported launching and maintaining Production Systems, KPI strategies as well as Quality Metrics programs in the pharmaceutical industry and beyond. His academic research focuses on Operational Excellence across manufacturing and quality control. Marten holds a B.Sc. in Mechanical Engineering, a M.Sc. in Production Engineering with focus on Corporate Optimization from RWTH Aachen University (Germany) and a PhD in Management from the University of St.Gallen. Prior to joining the Institute of Technology Management, he researched at the Laboratory for Machine Tools and Production Engineering (WZL) and worked in process engineering as well as lean optimization with automotive companies.
PHARM Connect Congress 2022
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Prof. Dr. Christoph Herwig Head of Research Group: Bioprocess Technology, Institute of Chemical Engineering, Vienna University of Technology, Austria
Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle.
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PRESENTERS
Dr. Louis Boon CSO & Management Board Member, JJP Biologics and Principal Scientific Advisor, Polpharma Biologics
Louis is the CSO and Management Board Member of JJP Biologics, an innovative new Polish company backed by the Starak family. JJP Biologics develops the next generation of novel therapeutic biologics around personalized medicine and companion diagnostics. Louis obtained his Ph.D. in Biochemistry at the University of Amsterdam. He was the founder of various companies focused on the generation and development of therapeutic monoclonal antibodies, primarily in the field of cancer and inflammation. In 2003, he was one of the founders of Bioceros BV, now Polpharma Biologics, where he currently holds the position of Principal Scientific Advisor. In addition, he held positions as CSO at MacroZyme BV, 4AZA Bioscience NV, FF Pharma, and VP preclinical for PanGenetics BV and Tanox. Louis is an author of over 340 publications in international scientific journals in the field of medical biotechnology and an inventor at more than 20 patent applications.
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Dr. Piotr Lipiński Global Quality Auditor, Audit & Compliance, Europe II, Novartis Technical Operations Quality
Piotr has over 12 years of experience in pharmaceutical companies. Currently, he is a Global Quality Auditor in Novartis, before he worked in pharmaceutical manufacturing sites as Quality Assurance Specialist, Qualified Person and Quality Systems Manager. The experience includes particularly quality systems implementation, self-inspections, training and auditing of materials, products suppliers and service providers. Piotr has detailed knowledge in the scope of all GxP rules with a special focus on Good Manufacturing Practice and Good Distribution Practice. Piotr is a PhD Eng. in the scope of Technology of Chemistry. Additionally, he completed postgraduate studies in the scope of Industrial Chemistry at the Medical University of Gdansk. He was participating as well in numerous courses related to GMP aspects in the pharmaceutical industry.
Giovanni Campologno eMBA, Biopharma Segment Manager, Hamilton Bonaduz AG
Giovanni Campologno is a business development professional with experience in Biopharma, Chemical and Food Industry. Giovanni is working for the Business Unit Process Analytics by Hamilton Bonaduz AG as Segment Manager dedicated to the development of product and services portfolio for biopharma PAT applications: upstream and downstream. This includes active partnership with private industry as well as public organizations. PHARM Connect Congress 2022
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István Király Managing Director of HUMAN BioPlazma, Kedrion Biopharma
Łukasz Lipiński
István Király graduated from the Technical University in Budapest as a mechanical engineer. During his professional career he has filled several technical- and production-related management positions in different industries at large international companies such as General Electric, DANONE, Alcoa and GlaxoSmithKline.
Junior Process Expert & Production Coordinator, Novartis
These challenges allowed him to be involved in the implementation and operation of different management and quality systems such as ISO, HACCP, GMP, Toyota Production System, Six Sigma and Lean Sigma. In 2006 he joined GSK Vaccines and started his career in Gödöllő Manufacturing site. He held various senior management positions until he was appointed as Managing director of the site in 2011. In 2015 he was nominated to VP, Head of Operations of the legacy Novartis Vaccines sites, overseeing the industrial operations of those sites and also managing the integration of those newly acquired manufacturing units into GSK Vaccines industrial network. In 2016 he was promoted to VP, Site Director Siena & Rosia Operations, Italy at GSK Vaccines. In 2018 István returned to Hungary, and joined HUMAN BioPlazma (part of Kedrion Group) as Site Director.
PHARM Connect Congress 2022
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Łukasz graduated at the Lodz University of Technology, Faculty of Organization and Management, majoring in Management and Production Engineering, specialising in Logistics in 2007. He started his professional career while he was in college, working in the FMCG market at Coca-Cola HBC Polska Sp. z o.o., gaining professional experience in many positions for 6 years, mainly responsible for calculation of logistics indicators, inventory control and cooperation with distribution companies. Later he started working for Leroy Merlin Polska Sp. z o.o., where he was mainly responsible for optimising the efficiency of warehouse processes and for the cost and efficiency control of the Logistics Operator. Since 2014 he is gaining experience in the pharmaceutical market at Lek S.A. / Sandoz (Novartis group). He started working in the SCM department, then Continuous Improvement. He was responsible for the administration and creation of logistics databases, leading optimisation projects and spreading a design culture based on the methodology of Lean Six Sigma. Currently he is working as an OpEx and technology specialist on the production of tablets, where he acts as the Production Coordinator. He implements optimisation projects and is responsible for the standardisation of technological processes. 15 CONTACT US
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Przemysław Młynarczyk Ana Dzaleva Sourcing Manager, Alkaloid
Out of 25 years of professional experience, Ana is with Alkaloid for 13 years now, all of them in the Procurement department. Her main responsibilities are: planning and procurement of the complete portfolio of in-license pallet of the company, responsible for procurement of all API & raw materials needed for the production of the company; creating and maintaining good relationships with suppliers, generating and implementing efficient sourcing. Ana holds a Master of Technical Sciences in the field of Industrial Engineering and Management from Ss. Cyril and Methodius University of Skopje, Faculty of Mechanical Engineering.
Przemyslaw Wierzbicki Project Engineer & Head of Continuous Improvement at Packaging Plant, Novartis
Przemysław has over 7 years of experience in pharmaceutical industry. Currently, he is a Project Engineer and is responsible for continuous improvement in packaging plant. The experience includes particularly lean management tools implementation, implementation of IT systems supporting performance management, building and optimization of processes supporting production, problem solving trainings. Przemysław is passionate about inspiring colleagues to continuous improvement and to be curious. 16 CONTACT US
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Senior Process & OPEX Expert, Novartis
Przemysław has been associated with the pharmaceutical industry since 2002. He has experience in the area of production, manufacturing process technology, project implementation of new production devices, grow-up production volume, product transfer, and OPEX. He participated in many implementation projects and optimisation projects related to, for example, waste reduction, process efficiency improvement, improvement of materials and raw materials.
Roland Straub Global Head of Digital Supply Chain, Takeda Pharmaceuticals International
Experienced Senior IT & Supply Chain Manager with demonstrated history of working in Pharmaceutical and Fast Moving Consumer Goods industry (companies include e.g. Takeda, Coca-Cola Hellenic and Johnson & Johnson). Skilled in End-to-End Supply Chain Management, Strategy Development & Deployment as well as Business Digitization. Implemented various big change management initiatives in both digital and operational area and managed turn-around in business areas. At the moment he is thrilled to embark on a data & digital acceleration journey in a completely new business setting where he created a fully integrated Data, Digital & Technology function embedded in Takeda Global Manufacturing & Supply and Global Quality function.
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Łukasz Krause Group CIO, Polpharma Group
Łukasz acts as Chief Information Officer at Polpharma, the largest Polish manufacturer of pharmaceuticals and a leader of the Polish pharmaceutical market, which actively operate in the markets of Central and Eastern Europe, the Caucasus and Central Asia. He is focused on business-IT and data transformation as well as the implementation of innovative solutions to the organization’s operations. Previously worked for the international and Polish energy sector, where he was responsible for IT transformation covering over 700-person team. Member of the CIONET Polska Program Council.
Błażej Różański Senior Production Systems Specialist, Department of Manufacturing Science & Technology, Polpharma
Błażej has over 5 years of experience in the pharmaceutical industry. Currently, he is a Process Engineer at Polpharma involved in the administration of MES and serialization systems. He is responsible for the continuous improvement of employees in working with IT systems. The experience includes, in particular, the implementation of IT systems supporting performance management, the construction and optimization of processes supporting production and training staff in problem solving. Błażej is a master’s degree in the scope of Chemical Technology. He was participating as well in numerous courses related to GMP aspects in the pharmaceutical industry and is an active member of the PAS-X user forum.
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PLANT EXCURSION
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PRE - EVENT PROGRAMME | 16th MAY 2022
Site visit to to the Novartis plant & packaging center in Stryków Podlipie 16, 95-010 Stryków, Poland
The congress also provides an opportunity to visit the Novartis Plant & Packaging Centre in Stryków, limited for 40 delegates and available on a first come first serve complimentary basis at 14:00 in the afternoon on 16th May. This will last for approximately 2 hours and delegates will be split into two groups, 20 people joining a section focusing on production and quality and a further 20 comprising a group focusing on warehousing and packaging. TRANSFER: The bus will leave from the front entrance of the Warsaw Marriott Hotel on 16th May at 12:30 in the morning and will return after the visit at approximately 17:30. BULK – PRODUCTION:
Bulk unit in Styków (BCS) is modern, big scale facility production centre focused on manufacturing of generic solid dosages drugs. Facility opened in 2004 and originally planned for around 1billion tablets today, in the same foot print has an impressive capacity of + 10 billion. BCS plays significant role in Novartis Technical Operations network supplying over 8 billion tablets (from around 5000 batches) on yearly basis serving two packaging facilities in Poland as well as customers in Canada, Slovenia and Germany. Innovative approach to mature generic products and fit to purpose and standardized equipment allows efficient manufacturing processes and as consequence very competitive costing for our customers and eventually for Patients around the world. Current product portfolio concentrates around alimentary tract and metabolism (mostly metformin) and cardiovascular (bisoprolol, ramipril and torademide). QUALITY:
Quality Unit consists of Quality Assurance and Quality Control. Quality Assurance teams are located according to main responsibilities – close to Production Unit for Operational QA and in the main office building for Quality Systems and Compliance.
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Quality Control has QC laboratories in two locations. All our laboratories (chemical, microbiological and packaging material lab) are well equipped with modern techniques fulfilling data integrity requirements. In QC labs we test raw materials, API, finished products and packaging materials as well as environment. Central Testing Laboratory provides analytical testing services for other manufacturers in the scope of EU re-testing, stability testing and stability management. QC Lab is certified for Lean Lab management, supported with planning tools and continuous improvement. Next to QC team we have well-developed Analytical Science & Technology team responsible for analytical methods development, transfer, validation and equipment service. The design of the laboratories is compliant with GMP and HSE requirements. WAREHOUSE MANAGEMENT:
In Stryków we operate two automated warehouses dedicated to: bulk and packaging operations. The first one with a capacity of 8,2 k pallets supports bulk operations and is used for handling and storage of APIs, excipients and bulk manufactured locally prior it is shipped to Packaging Centres. The second one, with 50% bigger capacity (13,5 k pallets), started its operations only in 2015, is dedicated to packaging and used as a distribution warehouse for all products packed in Polish sites. Majority of its capacity is utilized by FDFs, the rest is consumed by primary and secondary packaging materials and bulk (both locally manufactured and imported from other suppliers). The warehouse and packaging operations are equipped with AGVs which ensure fully automated material between both operations. AGVs are also used on the production floor. KEY NUMBERS (2021):
1. Total pallets shipped to customers (Finished Dosage Form) ~ 72 k, over 1300 trucks 2. Total pallets received ~ 27 k 3. Total number of pallet on stock ~19 k PACK AGING CENTER STRYKÓW:
PCS started operation in 2015 and it is one of the newest site in Novartis. We are operating on 13 highly automated packaging lines with potential to increase our capacity additionally up to 24 lines. Each year we are growing and our products are supplied to over 80 markets. We have automated process: •
flow of material (on production and on warehouse)
•
digital flow of production documentation
•
online monitoring production execution system which allow to us trace online results and problems on each line using laptop or even cell phone what ensures fast reaction
•
format parts washer that help us to reduce time of cleaning and drying.
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VENDOR PROFILES
17 - 18 May 2022 | www.pharmconnect.eu
ANTARES VISION GROUP
Via Del Ferro 16, 25039 Travagliato (Brescia), Italy Tel: +39 030 7283 500 | info@antaresvision.com www.antaresvision.com
SERVICE & PRODUCT LISTING: Packaging Machinery & Equipment: Machinery and component, Labelling and RFID | Auto ID & Mobility solutions: Brand Protection, Anti-Counterfeiting | IT for the Pharmaceutical Industry | Others: Visual inspection machines, Track & Trace solutions, Smart data management, efficiency monitoring
Antares Vision Group is an outstanding technology partner in digitalization and innovation to guarantee the safety of products and people, business competitiveness and sustainability through a unique and comprehensive ecosystem of software and hardware solutions for the life science industries: inspection systems and automatic machines to ensure product quality, track & trace at line, plant, corporate and government level for regulatory compliance and end-to-end traceability, integrated data management within the production process and the supply chain.
Bonfiglioli Engineering S.r.l.
Via Vespucci 20, 44124 Ferrara, Italy Tel: +39 0532 715 631 info@bonfiglioliengineering.com www.bonfiglioliengineering.com
SERVICE & PRODUCT LISTING: Process Automation | Laboratory Equipment | Packaging Machinery & Equipment | Others: leak detection, packaging inspection and integrity solutions
Bonfiglioli Engineering is your packaging inspection and integrity solutions partner serving the pharmaceutical, food & beverage, metal can & aerosol, chemical and personal care industry. Bonfiglioli Engineering provides non-invasive and non-destructive inspection technologies, including Container Closure Integrity Testing (CCIT), Headspace Gas Analysis (HGA), and Automatic Visual Inspection (AVI) to help ensure your products are free from contamination. Established in 1974 Bonfiglioli Engineering has continuously invested, innovated and evolved, making breakthroughs in leak testing while offering a portfolio of inspection solutions (lab, offline, in-line and with combined testing technologies) for all packaging requirements. Not just a machine manufacturer, Bonfiglioli Engineering is your trusted partner for packaging integrity testing and analysis through feasibility studies, technical expertise, validation packages, product handling and custom-built solutions. 20 CONTACT US
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we take it personally | transport + iLogistics | www.cargo-partner.com
Find us in 140 offices in 40 countries around the globe. Our Pharma Competence Centers ensure an uninterrupted cold chain with high safety standards and consistent quality control. We provide unbroken cold chain service for the transport and storage of pharmaceutical products, with short transit times and constant temperature control for all goods between -70°C and +30°C.
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ul. Lubomirskich 1e, 37-200 Przeworsk, Poland Tel: +48 16 649 00 98 | office@engineering-bp.com www.engineering-bp.com
B&P ENGINEERING SP. Z O.O. SP. K.
SERVICE & PRODUCT LISTING: Custom/ Contract Manufacturing: Processing Machinery & Components, Blending, Drying, Filtration, Heat exchangers, Separation technology, Mixing, Process Automation | Others: Stainless steel industrial tank fabrication, Custom build modular process skid systems
A SINGLE, COMPLETE INTEGRATOR AND A PERFECT FINAL PRODUCT Engineering, project management, fabrication, manufacturing, welding, assembly, testing and installation make B&P Engineering your large scale ‘one-stop-shop’ for custom processing equipment. Deciding to start cooperation with us, you choose a comprehensive solution. You get full support in the implementation of your project. DESIGN AND PRODUCTION • various types of stainless steel tanks, reactors, vesels and mixers • non-standard stainless steel products and process equipment • completely engineered modular skid systems WIDE AND MODERN MACHINE PARK Production area: 30 000 m2 | 5 production halls | 600 employees As an OEM contract manufacturer, B&P Engineering has partnered with global pharmaceutical and chemical companies to reduce production costs and improve product quality. Top brands count on B&P Engineering fulfillment capabilities and engineering staff to continually increase their customer satisfaction. STAINLESS STEEL TANKS, VESSELS AND REACTORS B&P Engineering it’s a manufacturer of high quality tanks and vessels made of stainless steel and its derivatives. Each design of the storage or process tank is developed by the engineering department. • silo tanks • buffer tanks • mixing tanks • aseptic tanks 22 CONTACT US
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• • • • • • • • •
storage tanks melting tanks equalization tanks rectification columns sterilization chambers vacuum-pressure reactors fermentation tanks / fermenters tanks for products subject to excise duty non-pressure and low pressure tanks for corrosive or toxic materials
CUSTOM FABRICATION OF STAINLESS STEEL PRODUCTS AND PROCESS EQUIPMENT • B&P Engineering offers contract and custom manufacturing services of machine construction and advanced equipment. Our customers are leaders in the pharmaceutical, chemical and cosmetics industries. • degassing machines for powders and liquids • mixers and bag filter housings • granulators and processor • tablets drying chambers • pressure apparatus • powder mixers • vacuum dryers • mixing devices • crystallizers • separators • filter cages • decanters
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Our key differentiators
Count on us to deliver your life-saving goods worldwide. At CRYOPDP we are focused on our customer and patient needs. That is the reason why we, through a dedicated team, will plan, manage and implement a tailor-made temperature-controlled solution that will fit your requirements and business goals. Count on us to deliver your life-saving goods, worldwide. Count on CRYOPDP because, together, we can save lives.
Worldwide coverage
Pharma and Biopharma Experts
Full range of temperature-controlled logistics
Tailor made solutions to fit your requirements
Management Consulting
Added value solutions such as Dtp and Dangerous Goods Management
cryopdp.com
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cargo-partner GmbH
2401 Fischamend, Airportstraße 9, Austria Tel: +43 598 88 -0 | atfis@cargo-partner.com www.cargo-partner.com
SERVICE & PRODUCT LISTING: Cold Chain Packing, Storage & Distribution | Pharmaceutical Storage, Warehousing | Distribution | Courier, Express, Parcel | Freight Transport & Logistics Services: Air, Road
cargo-partner is a privately owned full-range info-logistics provider offering a comprehensive portfolio of air, sea, land transport and warehousing solutions. With almost 40 years of expertise in information technology and supply chain optimization, the company designs tailormade services for a wide range of industries to create competitive benefits for its customers all around the world. Founded in 1983, cargopartner generated a turnover of over one billion euro in 2020 and currently employs over 3,700 people worldwide. As an expert in handling pharmaceutical goods, cargo-partner offers hassle-free service for your healthcare logistics and provides unbroken cold chain service for the transport and storage of pharmaceutical products, with short transit times and constant temperature control for all goods between -70°C and +30°C.
CRYOPDP
2 avenue du Valquiou, CS 11025 Tremblay, France contact@cryopdp.com cryopdp.com
SERVICE & PRODUCT LISTING: Solutions for Biopharmaceuticals & Biologicals | Cold Chain Packing, Storage & Distribution | Freight Transport & Logistics Services: Air, Road
Everything began with a commitment to serve the life sciences and healthcare industries by offering global transport and innovative temperature-controlled logistics solutions. Being one of the market leaders in our sector and dedicated to the clinical trial and cell & gene therapy communities, we are operating in more than 150 countries intending to improve the health of people around the world. Truly focused on our customer and patient needs, we, through a dedicated team, plan, manage and implement a tailor-made temperature-controlled solution to fit your requirements and business goals. Count on us to deliver your life-saving goods worldwide - Count on CRYOPDP!
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Endress+Hauser
Kägenstrasse 2, 4153 Reinach BL, Switzerland Tel: +41 61 715 7700 | info@endress.com www.endress.com/pl
SERVICE & PRODUCT LISTING: Process Automation | Solutions for Biopharmaceuticals & Biologicals | Laboratory & Analytical Technology | Laboratory Equipment | Plant Engineering & Maintenance
Endress+Hauser is a global leader in measurement instrumentation, services and solutions for industrial process engineering. We provide process solutions for flow, level, pressure, analytics, temperature, recording and digital communications, optimizing processes in terms of economic efficiency, safety & environmental impact. Our customers come from various industries, including chemical, food & beverage, life sciences, power & energy, mining, minerals & metals, oil & gas and water & wastewater.
FRANCELAB (FRLAB Kft.)
Dutka Ákos u.64, 1029 Budapest, Hungary Tel: +36 30 466 9783 | info@francelab.hu www.francelab.hu
SERVICE & PRODUCT LISTING: Processing Machinery & Components | Sterile Supplies | Laboratory & Analytical Technology | Laboratory Equipment | Packaging Machinery & Equipment | Clean rooms & Accessories | Others: Solutions for API, Solid, Semi-Solid, liquid forms and biopharmaceuticals (instrument, equipment, single use,...) Reactors, Nutsche Filters, bioreactors, single use devices, H2O2 decontamination, derouging, filling, inspection machines, isolators
Through the different partners that we are representing in Central Europe, Francelab has become a solution provider for the pharmaceutical industry. Our range of solutions is covering all dosage form (liquid, solid and semi-solid forms) and includes the following technologies: Process equipment (reactors, fermentors, freeze drying technologies, energy skid ...), Mixing Drying Technologies (mixers, dryers, grinders ...), Filling - Packing (filling, sorting and inspection machines, dedusters), Washing - Sterilization (washers, autoclaves, H2O2 and biodecontamination ...), Clean Air and Safety (isolators, RABS, clean room renovation ...), Single Use Devices (tubings, bags, connectors, powder transfer ...)
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Z.A. de Montigny 3 – Maxilly, 74500 Evian-les-Bains, France Tel: +33 450 83 12 12 www.actini.com/en/
ACTINI
As an expert in heat treatment for more than 65 years, ACTINI offers a complete range of equipment designed to meet the needs of industries, CMOs and laboratories in the pharmaceutical, biotechnology and cosmetics industries. Decontamination of liquid effluent for industries or laboratories handling biological agents classified 1 to 4. • Sterilization of media or ingredients for the pharmaceutical, biotechnological and cosmetic industries, as well the ones of subcontractors and CMOs from these sectors. • Neutralization of the effluent coming from Batch and Continuous Flow Systems Its ability to innovate combined with a technical mastery and historical know-how have enabled it over the years to offer electricity or steam- operated “batch” or “continuous” solutions that are always more efficient for daily capacities of 40 to 400,000 liters. Ensuring the decontamination of the waste, they also answer the current problems which are productivity, profitability of the installations, compactness of the systems and preservation of the environment. •
Zone Industrielle 54, Rue Jean Duvert 33290 Blanquefort, France TeL: +33 5 56 35 08 40 | info@sofast-pharma.com www.sofast-pharma.com/en/
SOFAST
Located in Blanquefort, France, SOFAST has over 35 years of expertise in designing, manufacturing and installation of customized process equipment and solutions for laboratories and the pharmaceutical, biotechnology and cosmetic industries. Our goal: to put at your disposal our expertise and to propose you the most adapted solutions to sterilize, prepare, formulate and transfer your preparations and products thanks to our: Autoclaves, Isolators and glove boxes, Process tanks and Process skids.
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Hamilton Bonaduz AG
Via Crusch 8, 7402 Bonaduz, Switzerland Tel: +41 58 610 22 69 | lklimczak@hamilton.ch www.hamiltoncompany.com
SERVICE & PRODUCT LISTING: Process Automation | Solutions for Biopharmaceuticals & Biologicals | Laboratory & Analytical Technology | Laboratory Equipment
Hamilton Process Analytics, a division of Hamilton Bonaduz AG, pioneers open sensing solutions to enhance the understanding and control of critical process parameters, including pH, ORP, conductivity, and dissolved oxygen as well as total and viable cell density. This year also introducing the brand new & innovative CO2 sensor. First introduced in 1989, Hamilton sensors are found worldwide in applications ranging from biopharma to power generation to brewing. Hamilton continues to lead the industry with new innovations such as intelligent sensor management via Arc wireless technology, single-use solutions to significantly reduce risk of contamination and online viable cell density. Each Hamilton offering is supported by a full portfolio of accessories including armatures, transmitters, cables, buffers, and standards. Hamilton Bonaduz AG is the European counterpart of Hamilton Company, founded by Clark Hamilton in 1960 and headquartered in Reno, Nevada, USA. With more than 2,500 employees across global manufacturing facilities and subsidiaries, Hamilton is a leader in numerous fields including automated liquid handling robotics, automated sample management, medical ventilation, laboratory products, and process analytics.
Vimachem
49 Pigis Avenue Melissia 15127, Greece +30 210 609 5062 | info@vimachem.com www.vimachem.com
Vimachem’s Optimz Pharma 4.0 MES platform brings a unique approach to manufacturing execution systems, incorporating AI, IIoT and Pharma 4.0 principles, allowing pharmaceutical and biotech companies to scale faster with greater flexibility. Smart, adaptable and intuitive, the Vimachem Optimz MES platform enables the continuity and flow of information across the enterprise, providing the right data, at the right time, to the right team. Our team of world-class experts combines IT, OT and machine learning skills and having experienced the pain of non-real time production visibility and difficult to use tools, has built the Vimachem platform focused on ease of use and superior flexibility and integration capabilities that are fitted for modern pharmaceutical and biotech manufacturing. 28 CONTACT US
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Your vacuum drying specialist
Planex® System
CosmoDry® System
Horizontal vacuum dryer with eccentric agitator featuring ZeroFriction® planetary movement.
Horizontal vacuum dryer with concentric agitator removable in several parts.
Saurus939® Vacuum pump available in single stage, double stage and double stage model with one or two roots.
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Italvacuum S.r.l. via Stroppiana 3, 10071 Borgaro T.se (TO) IT www.italvacuum.com
Static tray vacuum dryer available with Multispray® fast washing system.
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Bi-conical rotary vacuum dryer available with electric lump-breakers.
Multispray® Cabinet Dryer
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Criox® System
UNI EN ISO 3834-2
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Fette Compacting GmbH
Grabauer Strasse 24, 21493 Schwarzenbek, Germany Tel: +49 41 51 120 | tablet@fette-compacting.com www.fette-compacting.com
SERVICE & PRODUCT LISTING: Processing Machinery & Components: Encapsulation, Tableting | Pharmaceutical Consultancy
Fette Compacting is the world’s leading provider of integrated solutions for industrial tablet production and capsule filling. The company specializes in high-performance machines for the pharmaceutical, nutraceutical, and chemical industry. With more than 5,000 installed machines, Fette Compacting is the global market leader for tablet presses in the pharmaceutical industry. The company has its headquarters in Schwarzenbek near Hamburg. A second technology and production facility is operated by Fette Compacting in Nanjing, China. Fette Compacting is the only manufacturer of tablet presses and capsule filling machines to operate its own global network with fully-equipped and digitally-connected Competence Centers in Germany, Brazil, China, India, and the US. The company is represented in more than 50 countries worldwide. Fette Compacting is a member of the LMT Group, a medium-sized, family-owned group of companies. The Group also includes LMT Tools, a leading manufacturer of precision tools for industrial processing of construction materials. More than 2,200 people work for LMT Group companies at over 20 locations worldwide. The Group achieved sales of 370 million euros in fiscal 2020.
Introl Automatyka Sp. z o.o. Sp. k.
Kościuszki 112; 40-519 Katowice, Poland Tel: +48 32 789 00 30 | biuro@introlautomatyka.pl www.introlautomatyka.pl
SERVICE & PRODUCT LISTING: Pharmaceutical Consultancy | Packaging Machinery & Equipment: Machinery and components, Labelling and RFID | Auto ID & Mobility solutions: Brand Protection, Anti-Counterfeiting | IT for the Pharmaceutical Industry | Clean rooms & Accessories: Validation
The INTROL Group is a holding company providing advanced solutions, among others, in the field of automation, industrial measurements and IT for many industries, listed on the Warsaw Stock Exchange since 2007. With 30 years of experience, over 1600 employees and over 30 countries in which we operate, we are one of leaders of industrial automation in Poland. Introl Automatyka provides comprehensive engineering and consulting services for pharmaceutical industry. We are team of engineers with 15+ years of experience in GMP environment.
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Innovative Cleanroom Systems by Kingspan
High-end, modular cleanroom solutions delivered seamlessly by the technology experts. INNOVATION SERVICE & SUPPORT QUALITY & COMPLIANCE VERSATILITY & FLEXIBILITY
Come and discuss your requirements today or visit www.kingspan.com
Pharma Software
Digitize your pharma factory ! •
Boost your performance and quality with Werum PAS-X, the leading pharma MES
•
Uncover hidden business value with our data analytics and AI solutions
•
Accelerate your product commercialization with process data management
koerber-pharma.com
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Instrumentation & control equipment
We offer following services: Serialization and track&trace: • • • •
Machines and facilities modernizations (retrofitting/robotization)
L1-L5 software solution Serialization and aggregation machines Rework stations Training & education services
Services: • • •
IT solutions: • • • •
Electronic Batch Record (EBR) Process and storage conditions monitoring Control & data acquisition systems Pharmaceutical cloud
Validation & qualification Education & consulting Accredited laboratory
Via Stroppiana, 3 - 10071 Borgaro Torinese, Italy Tel: +39 011 470 4651 | marketing@italvacuum.com www.italvacuum.com
Italvacuum
SERVICE & PRODUCT LISTING: Processing Machinery & Components: Pumps, compressors and blowers, Drying, Separation technology | Laboratory Equipment
Italvacuum is an international manufacturer of vacuum pumps and vacuum dryers for pharmaceutical, chemical and fine chemicals industries. Italvacuum’s manufacturing capabilities include a wide range of original and patented products, that comply with the main International Standards (UL, ATEX, ASME and PED) and with FDA and cGMP regulations: • • • • •
paddle dryers with eccentric or concentric agitator double cone rotary dryers / powders tray dryers with extractable or fixed shelves laboratory-scale tray dryers single stage and double stage vacuum pumps.
Italvacuum also offers a wide range of services: Engineering Pilot trials Customer service. Thanks to over 80 years of experience, Italvacuum is able to provide turnkey installations and also to realize bespoke equipment and systems, that are built according to customer’s process requirements. The highest levels of quality, safety and productivity in any application, with a special care for sustainability and total respect for the environment.
• • •
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Your trusted solution partner For pharmaceutical primary packaging and drug delivery devices. Technical product development, clean room manufacturing, and regulatory services – all from a single source.
Röchling Medical – Passion for Health www.roechling.com/medical
Visit us at Pharm Connect Congress 17th – 18th May
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Kingspan Ltd.
Greenfield Business Park, 2 Bagillt Road, Holywell, CH8 7GJ, UK Tel: +36 30 230 3713 | balazs.bankuti@kingspan.com www.kingspan.com
SERVICE & PRODUCT LISTING: Clean rooms & Accessories: Clean room construction
Kingspan Group is a global leader in solutions for high performance, low carbon buildings. Our products and systems ensure higher lifetime energy and carbon savings. Collectively, our businesses deliver a complete sustainable building envelope - the materials and systems that separate the inside and outside of a building - that generates better building performance and higher value for our customers. One of five divisions within the Group, Kingspan Insulated Panels manufactures a range of high-performance building envelope solutions primarily for the non-domestic sector, including steel-faced insulated panels, architectural wall panels and facade systems, wall daylighting solutions, coldstore and cleanroom systems. Kingspan Cleanroom Systems is part of the Kingspan Insulated panels division and with a choice of two interchangeable systems, Cleanrooms offer customisable solutions for your specific cleanroom requirements and aspirations, delivered seamlessly by the technology experts. UltraTech Cleanroom Systems are backed up by exceptional 360° support from specification, technical advice, 3D representation, manufacture, installation, and project handover.
Körber Pharma Software
Wulf-Werum-Str. 3, 21337 Lüneburg, Germany Tel: +49 4131 8900-0 | info.pasx@koerber.com koerber-pharma.com
SERVICE & PRODUCT LISTING: Process Automation | Pharmaceutical Consultancy | Solutions for Biopharmaceuticals & Biologicals | IT for the Pharmaceutical Industry
Körber is an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire.
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“Invaluable instrument in pharmaceutical process development”
DESIGNED BY SCIENTISTS FOR SCIENTISTS
THE NEW INDUSTRY STANDARD • • • • •
Advanced temperature features Ground-breaking transmissivity technology State-of-the-art software Feedback control Overhead and bottom stirring
Contact us for more information info@crystallizationsystems.com crystallizationsystems.com
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At the Körber Business Area Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions. With our software solutions we help drug manufacturers to digitize their pharmaceutical, biotech and cell & gene factories. The Werum PAS-X MES Suite is recognized as the world’s leading Manufacturing Execution System for pharma, biotech and cell & gene. Our Werum PAS-X Intelligence Suite accelerates product commercialization with data analytics and AI solutions and uncovers hidden business value.
RAUMEDIC AG
Hermann-Staudinger-Straße 2, 95233 Helmbrechts, Germany Tel: +49 9252359-0 | contact@raumedic.com www.raumedic.com
SERVICE & PRODUCT LISTING: Custom/ Contract Manufacturing | Drug Delivery Systems | Process Automation | Sterile Supplies | Packaging: Plastics | Solutions for Biopharmaceuticals & Biologicals | Laboratory Equipment | Packaging Machinery & Equipment: Packaging materials, Labelling and RFID | Auto ID & Mobility solutions: Brand Protection, Anti-Counterfeiting | Others: Customised tubing and bag sets assembled according to customers’ needs, and injection molded customised parts made of all kinds of thermoplasts and especially silicone.
70 years of experience in extrusion, injection molding and assembly for medical and pharmaceutical companies worldwide. Human health is at the core of our business. As a development partner of the international medical technology and pharmaceutical industry, we process thermoplastic polymers as well as silicones into customer-specific products. Our tubing solutions, catheters, molded parts, assemblies and systems facilitate the diagnosis and treatment in various clinical fields. As a result, we contribute significantly to safe patient care all over the world. “Our goal is to open up new ways and possibilities for maintaining the quality of life and for the restoration of the health of those who suffer from diseases.” RAUMEDIC combines decades of experience in medical technology with the efficiency and dynamics of a modern company. We are a medium-sized company and attach high value on the quality of our products. We offer our customers polymer and elastomer product concepts. Produced through extrusion, injection molding and assembly, these can be used in many fields of application within the medical and pharmaceutical industry. In our own research & development and engineering departments we develop customized products and manufacture these at our five locations in Germany, Estonia and the US. We have a global distribution network, and we are represented in selected markets by our own distribution companies.
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Waldweg 16, 98724 Neuhaus am Rennweg, Germany Tel: +49 3679 72606-0 | sales.deneu@roechling.com www.roechling.com/medical
Röchling Medical SERVICE & PRODUCT LISTING: Packaging: Plastics
Röchling Medical is a trusted and reliable partner of leading pharmaceutical, biotech and medtech companies worldwide, offering a wide range of high-quality, customized components and assemblies, including end-to-end OEM products. We manufacture under cleanroom conditions at six locations in Germany, the US and China. For the Pharma and Diagnostics markets, Röchling Medical develops and manufactures high-quality, customized plastic primary packaging solutions, as well as application aids and drug delivery systems for the simple and safe dosing and administration of drugs. We also offer a broad spectrum of standard packaging options for a variety of dosage forms for the human pharma and animal health markets. Our product portfolio is complemented by a comprehensive range of services along the whole process chain, including packaging, sterilization and regulatory support. Röchling Medical is part of the Röchling Group, headquartered in Mannheim, with more than 11,000 employees at 90 locations in 25 countries worldwide.
SoftGroup
49 Bulgaria Blvd., Sofia, Bulgaria Tel: +359 2 879 9577 | sales@softgroup.eu www.softgroup.eu
SERVICE & PRODUCT LISTING: Packaging Machinery & Equipment: Labelling and RFID
SoftGroup is a software company that provides end-to-end traceability technology to the pharmaceutical industry worldwide. In our 18 years of experience, we have been recognized by manufacturers and Marketing Authorization Holders (MAHs) as a reliable serialization and aggregation solution provider. Our solutions cover all levels of the Track & Trace process, including aggregation processes in pharmaceutical manufacturing.
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PROCESS Chemical Reactors Biofermentors Freeze Drying Technologies
CLEAN AIR SYSTEMS RABS Isolators Sampling Booth
SINGLE USE DEVICES Tubings Single Use Bags Connectors Customized solutions Single Use System for Powder Transfer GRINDING – MIXING - DRYING Grinders & Micronizers Vacuum Dryers & Nutsche filter dryer Mixers & Industrial Centrifuges Mixing Systems for liquids and pastes TRANSFER – FILLING - PACKING Vacuum Conveyors Tablet & Capsules Dedusters Sealing Machines Filling machine for powders Filling machines for liquid and semi solids Complete filling lines for ampoules & vials Inspection and leak test equipment DESINFECTION – DECONTAMINATION - WASHING GMP Autoclaves GMP Washers H2O2 Decontamination Systems Effluent and Biowaste Decontamination
WWW.FRANCELAB.HU
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Selvita
Park Life Science, Bobrzynskiego 14, 30-348 Krakow, Poland Tel: + 48 122 974 700 | anna.gruszczynska@selvita.com selvita.com
SERVICE & PRODUCT LISTING: Custom/ Contract Manufacturing | Solutions for Biopharmaceuticals & Biologicals | Outsourcing | Others: Contract laboratory organisation
Selvita is a preclinical Contract Research Organization providing multidisciplinary support in resolving the unique challenges of research within the areas of drug discovery and drug development studies. Selvita was established in 2007 and currently employs over 900 professionals, of which over 40% hold a PhD degree. The Company research sites are located in Krakow (HQ) and Poznan, Poland, as well as Zagreb, Croatia. Selvita’s international offices are located in Cambridge, MA, and San Francisco Bay Area, in the U.S., as well as in Cambridge, UK. Selvita provides state-of-the-art analytical services supporting pharmaceutical and biopharmaceutical companies at various stages of drug development and CMC processes by providing contract laboratory services for testing. We have a diverse analytical instrumentation and expertise portfolio, allowing us to meet varied demands, including testing of starting materials, drug substances, intermediates, and final products of small and large molecules. Selvita complies with GMP and GLP requirements to meet the highest industry standards.
Technobis Crystallization Systems B.V.
Pyrietstraat 2, 1812SC Alkmaar, The Netherlands Tel: +31 72 30 200 40 info@crystallizationsystems.com www.crystallizationsystems.com
SERVICE & PRODUCT LISTING: Laboratory & Analytical Technology | Laboratory Equipment
Technobis Crystallization Systems is a world leading technology provider for solid-state research, process development and formulation. Our mission is to help research succeed! Since 2005, platforms for accelerating crystallization research have been successfully developed and installed in nearly every pharmaceutical research lab in the world. With more than 500 units in the field, a large 40 CONTACT US
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community of scientists have been enabled to make a significant contribution to the accelerated development of new pharmaceuticals. In the last few years, new applications have been developed in agrochemical, fine chemical, military and (bio) fuel research, food and personal care creating new markets focused on understanding the importance of crystallization research. Our workflow consists: The CrystalBreeder™ is the first crystallizer dedicated for both development and discovery, carrying out complete crystallization screens with as little as 1mg of sample. The Crystal16® parallel crystallizer is a multiple reactor station providing a screening solution for solubility determination, solid-state research and process development: medium-throughput crystallization studies at a 1ml scale. With 8 independently controlled reactors and additional analytical capabilities, the Crystalline™ is a unique modular product line at a working volume of 5 ml for solid-state research, process development and formulation research.
Tive
56 Roland Street Suite 100A, Boston MA 02129, USA Tel: +1 617 631 8483 | sales@tive.com www.tive.com
SERVICE & PRODUCT LISTING: Process Automation | Laboratory & Analytical Technology | Packaging Machinery & Equipment: Labelling and RFID | Cold Chain Packing, Storage & Distribution | Freight Transport & Logistics Services: Air, Road | Others: Real-Time Supply Chain Visibility
Tive is a leading provider of real-time supply chain visibility insights that help logistics professionals actively manage the location and condition of their shipments. With Tive, shippers and logistics service providers (LSP) eliminate delays, damage, and shipment failures to ensure shipments arrive on time and in full. Tive’s solution provides data generated by its industry-leading trackers allowing clients to actively optimize their shipments, improve their customers’ experience, and unlock supply chain insights in an actionable real-time manner. For more information, visit www.tive.com.
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Veltek Associates, Inc.
15 Lee Boulevard, Malvern, PA 19355-1234 USA Tel: +1 610 644 8335 | europe@sterile.com www.sterile.com
SERVICE & PRODUCT LISTING: Sterile Supplies | Pharmaceutical Consultancy | Packaging Machinery & Equipment: Labelling and RFID | IT for the Pharmaceutical Industry | Clean rooms & Accessories: Clean room garments, Validation | Others: Environmental Monitoring Devices, Sterile and non sterile disinfectants, sporicidal agents and detergents, Cleanroom documentation
VAI’s manufacturing and testing operations mirror current GMP and GLP standards. We offer a comprehensive line of disinfectants, sporicides, residue removers, detergents/process cleaners and quality water. A majority of our chemicals are available as sterile presaturated wipers in addition to multiple types of dry wipe substrates. A completely redesigned quality garment line with two material types for user comfort or optimum protection, an innovative line of cleanroom paper, documentation materials, printing systems, cleaning equipment, cart transfer systems, and viable sampling systems; facility wide or portable versions. In addition, VAI provides consulting and laboratory services with over 35 year of contamination control experience.
ZETA GmbH
Zetaplatz 1, A-8501 Lieboch, Austria Tel: +43 3136 9010-0 | office@zeta.com www.zeta.com/en/
SERVICE & PRODUCT LISTING: Processing Machinery & Components: Filtration, Separation technology, Mixing | Process Automation | Pharmaceutical Consultancy | Solutions for Biopharmaceuticals & Biologicals | Clean rooms & Accessories | Plant Engineering & Maintenance: Modular production facilities | Cold Chain Packing, Storage & Distribution | Others: Digitalization and Pharma 4.0, Decarbonization and Sustainability
The ZETA Group, with 1.000 highly qualified employees and 17 subsidiaries worldwide, specializes in planning, automation, digitization and maintenance of customized biopharmaceutical facilities for aseptic process solutions. ZETA acts as a one-stop shop, combining plant engineering with HVAC and cleanroom design. Biopharmaceutical active ingredients, such as anti-cancer drugs, insulin, vaccines and infusions are produced in these highly complex, “tailor-made” facilities. ZETA supports its customers along the entire drug development and manufacturing pathway with sophisticated solutions from laboratory to industrial production scale. Through its Smart Engineering Services, ZETA creates digital twins of process plants and has thus established itself as a market leader for digital solutions in the pharmaceutical and biotech industry. ZETA is also actively taking steps towards a more sustainable future for the industry as a whole: through ZETA’s decarbonization strategies, emissions are specifically reduced during the biopharmaceutical manufacturing process. 42 CONTACT US
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INTEGRATED CONTRACT LABORATORY SERVICES Selvita provides analytical services supporting pharmaceutical and biopharmaceutical companies at various stages of drug development and CMC processes.
State-of-the-art research facilities 14 500 m2 (155,000 ft2) of lab space
We have a diverse instrumentation and expertise portfolio, allowing us to meet varied demands, from testing of starting materials up to evaluation of final products of small and large molecules.
Established market position 15 years of experience Over 900 employees incl. 40% with a Ph.D.
Proven expertise & track record with small molecules and biologics Certified laboratories GMP accreditation GLP accreditation
CONTACT US
Selvita S.A. Bobrzynskiego 14 SALES@SELVITA.COM 30–348 Krakow, Poland WWW.SELVITA.COM P: +48 12 297 47 00
The illustrated product may include optional equipment. Maximum performance dependent on machine configuration and production settings.
THE NEW F30i – PROTECTION BY DESIGN Dust-tight in function. Contained if necessary. Safety in all forms, up to 1.6 m times per hour. www.fette-compacting.com
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PRODUCT LISTING
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CUSTOM/ CONTRACT MANUFACTURING B&P Engineering Sp. z o.o. Sp. k.
Filtration B&P Engineering Sp. z o.o. Sp. k. ZETA GmbH
RAUMEDIC AG
Heat Exchangers
Selvita
B&P Engineering Sp. z o.o. Sp. k.
DRUG DELIVERY SYSTEMS
Separation technology
RAUMEDIC AG
PROCESSING MACHINERY & COMPONENTS Francelab (Frlab Kft)
B&P Engineering Sp. z o.o. Sp. k. Italvacuum ZETA GmbH Mixing B&P Engineering Sp. z o.o. Sp. k. ZETA GmbH
STERILE SUPPLIES Francelab (Frlab Kft) RAUMEDIC AG Veltek Associates, Inc.
PACKAGING Plastics RAUMEDIC AG Röchling Medical
PHARMACEUTICAL CONSULTANCY Fette Compacting GmbH
Pumps, compressors and blowers
Tableting
Introl Automatyka Sp. z o.o. Sp. k.
Italvacuum
Fette Compacting GmbH
Körber Pharma Software Veltek Associates, Inc.
Blending B&P Engineering Sp. z o.o. Sp. k.
PROCESS AUTOMATION
ZETA GmbH
Drying
B&P Engineering Sp. z o.o. Sp. k.
SOLUTIONS FOR BIOPHARMACEUTICALS & BIOLOGICALS
B&P Engineering Sp. z o.o. Sp. k. Italvacuum Encapsulation Fette Compacting GmbH
Bonfiglioli Engineering S.r.l. Endress+Hauser
CRYOPDP
Hamilton Bonaduz AG
Endress+Hauser
Körber Pharma Software
Hamilton Bonaduz AG
RAUMEDIC AG
Körber Pharma Software
Tive
RAUMEDIC AG
ZETA GmbH
Selvita ZETA GmbH
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Labelling and RFID
LABORATORY & ANALYTICAL TECHNOLOGY
ANTARES VISION GROUP Introl Automatyka Sp. z o.o. Sp. k.
Endress+Hauser Francelab (Frlab Kft) Hamilton Bonaduz AG Technobis Crystallization Systems B.V.
RAUMEDIC AG
CLEAN ROOMS & ACCESSORIES Francelab (Frlab Kft) ZETA GmbH Clean room construction
SoftGroup Tive Veltek Associates, Inc.
Tive
Kingspan Ltd. Clean room garments
AUTO ID & MOBILITY SOLUTIONS
LABORATORY EQUIPMENT
Veltek Associates, Inc. Validation
Bonfiglioli Engineering S.r.l.
Brand Protection, Anti-Counterfeiting
Introl Automatyka Sp. z o.o. Sp. k.
Endress+Hauser
ANTARES VISION GROUP
Veltek Associates, Inc.
Francelab (Frlab Kft)
Introl Automatyka Sp. z o.o. Sp. k.
Hamilton Bonaduz AG Italvacuum
RAUMEDIC AG
PLANT ENGINEERING & MAINTENANCE Endress+Hauser
RAUMEDIC AG Technobis Crystallization Systems B.V.
IT FOR THE PHARMACEUTICAL INDUSTRY
PACKAGING MACHINERY & EQUIPMENT
ANTARES VISION GROUP
Bonfiglioli Engineering S.r.l.
Introl Automatyka Sp. z o.o. Sp. k.
Francelab (Frlab Kft)
Körber Pharma Software Veltek Associates, Inc.
Machinery and components ANTARES VISION GROUP Introl Automatyka Sp. z o.o. Sp. k.
PLANT ENGINEERING & MAINTENANCE Modular Production facilities ZETA GmbH
COLD CHAIN PACKING, STORAGE & DISTRIBUTION CRYOPDP cargo-partner GmbH Tive
RAUMEDIC AG
ZETA GmbH
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PHARMACEUTICAL STORAGE, WAREHOUSING cargo-partner GmbH
Reactors, Nutsche Filters, bioreactors, single use devices, H2O2 decontamination, derouging, filling, inspection machines, isolators
OTHERS: Visual inspection machines ANTARES VISION GROUP
DISTRIBUTION cargo-partner GmbH
OUTSOURCING Selvita
COURIER, EXPRESS, PARCEL cargo-partner GmbH FREIGHT TRANSPORT & LOGISTICS SERVICES Air
Francelab (Frlab Kft)
Track & Trace solutions ANTARES VISION GROUP
Customised tubing and bag sets assembled according to customers’ needs, and injection molded customised parts made of all kinds of thermoplasts and especially silicone
Smart data management, efficiency monitoring ANTARES VISION GROUP Stainless steel industrial tank fabrication
RAUMEDIC AG
B&P Engineering Sp. z o.o. Sp. k.
Contract laboratory organization Selvita
Custom build modular process skid systems
Real-Time Supply Chain Visibility
B&P Engineering Sp. z o.o. Sp. k.
Tive
Leak detection, packaging inspection and integrity solutions
Environmental Monitoring Devices
Bonfiglioli Engineering S.r.l.
Veltek Associates, Inc. Sterile and non sterile disinfectants, sporicides and detergents
cargo-partner GmbH
Solutions for API, Solid, Semi-Solid, liquid forms and biopharmaceuticals (instrument, equipment, single use,...)
Tive
Francelab (Frlab Kft)
Cleanroom documentation
CRYOPDP cargo-partner GmbH Tive road CRYOPDP
Veltek Associates, Inc.
Veltek Associates, Inc. Digitalization and Pharma 4.0; Decarbonization and Sustainability ZETA GmbH PHARM Connect Congress 2022
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MEDIA PARTNERS
17 - 18 May 2022 | www.pharmconnect.eu
Special Thanks to our Media Partners! Exclusive Media Partner
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CEE’S PHARMACEUTICAL MANUFACTURING
EXCELLENCE AWARD
17 - 18 May 2022 | www.pharmconnect.eu
TEG The Events Group - the organiser of the PHARM Connect Congress - is proud to announce the call for applications for the Central Eastern European Pharmaceutical Manufacturing Excellence Award each year. The aim of the award is not only to celebrate excellence in manufacturing, but to encourage professionals to constantly raise standards contributing to the development of CEE as a region. Review the memory of the past year’s winners and find out more about the application on https://pharmconnect.eu/en/excellence_award/
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AWARD WINNERS
SOLUTION PROVIDER CATEGORY
AB BB
TE MPIX TEM TE X
2015
2016
2017
SA A N O FI
2018
2019
LEK LE KP Ph har a rma mac ce eutt ic ical cal als
AWARD WINNERS
MANUFACTURER CATEGORY
Flex
MEDITO TOP P Ph Ph a r m ac ce eut utic ica als
LEK Pharma ace c eutt ic ical als ls
Flex
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EXCELLENCE AWARD 17 - 18 May 2022 | www.pharmconnect.eu
SUMMARY AND OVERVIEW OF AWARDED PROJECTS
- Will you be next?
Videojet Technologies | www.videojet.com
Blulog | www.blulog.eu
SoftGroup | www.softgroup.eu
Videojet was selected as a joint winner in both categories.The company designed a Thermal inject printer for integration into complex track and trace lines. In cooperation with a solution provider company, they conducted comprehensive trials to confirm the product’s suitability in terms of integration, performance and control. Due to the built-in productivity improvements, the new printer reduces ink consumption, line stops, changeovers, operator errors and improves operational security.
Blulog developed an innovative solution for temperature and humidity monitoring and produced NFC connected boxes to assure control during drug transportation. The product provides immediate access to the data, graphs and PDF reports, and it sets up quick alerts in case of cold chain breach. It is highly precise and complies with the required Pharma regulations.
SoftGroup together with their client Tchaikapharma from Bulgaria developed a Serialisation and Track & Trace (SaTT) solution for the pharmaceutical industry to comply and cover the requirements of the European Union’s Falsified Medicines Directive.
AWARD WINNERS
SOLUTION PROVIDER CATEGORY
ABB | www.new.abb.com
TEMPIX | www.tempix.com
ABB went beyond its customer original requirements and provided solutions that helped to improve process robustness, maintain education level of the personnel and most of all reduce potential human errors (deviations). It required more than just providing automation solutions but it meant understanding the process, understanding the requirements of pharmaceutical industry, especially biotech and understanding cGMP and its new trends. This requires also an excellent customer focus.
The Sweden-based Tempix - which also operates in Central and Eastern Europe - delivered a unique, innovative barcode label that indicates if the product temperature exceeds its specified temperature limit. The solution is very cost-efficient, based on a simple and environmentally friendly technology that benefits everyone, from producers and transporters to shops and customers.
2015
2016
2018
2017
SANOFI | www.sanofi.com
Lek Pharmaceuticals | www.lek.si
Sanofi’s application was selected because the team went beyond its boundaries, took a holistic view and was brave enough to challenge the existing status quo. This approach yielded several benefits like: cost saving (35%), gaining new activities, saving jobs as well as maintaining an excellent customer focus, not just for the internal customer but also for their end customers (patients).
Lek Pharmaceuticals d.d. from Slovenia developed an improved children friendly antibiotic medication in a form of quickly dissolving tablet. The main deliverables of development were: a pleasant taste – improved patient compliance, improved storage conditions and administration flexibility.
AWARD WINNERS
MANUFACTURER CATEGORY
2019
MEDITOP | www.meditop.hu
Lek Pharmaceuticals | www.lek.si
Meditop developed an innovative approach to improve film coating efficiency with a method to coat soft tablets and heat-sensitive actives without degradation. Thanks to this technology they saved considerable time and energy as well as obtained flexible and fast change-over and batch size change.
Lek Pharmaceuticals with the Development Centre in Slovenia developed a real-time particle size and shape analysis method, which allows more efficient process control and rapid detection of deficiencies in the production of multi-layer coatings. The new solution greatly contributes to shorter manufacturing times and more cost-effective manufacturing processes.
PHARM Connect Congress 2022
CEE’s Leading Pharmaceutical & Biotechnology B2B Networking Event
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Apply for the 8th Pharmaceutical Manufacturing Excellence Award in 2023!
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LEADING B2B NETWORKING EVENT
FOR PHARMACEUTICAL & BIOTECHNOLOGY PROFESSIONALS
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TEG The Events Group is one of Europe’s leading business information providers, operating primarily within the key emerging markets of Central and Eastern Europe. The main focus is on business-to-business congresses that connect top professionals within various industries in the region, bringing together senior executives from Europe’s largest companies with leading service providers.
2022 BUDAPEST 23-24 NOVEMBER w w w. t r a n s l o g c o n n e c t . e u
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FOR LOGISTICS AND SUPPLY CHAIN MANAGEMENT PROFESSIONALS
Apply for the 9th Logistics & Supply Chain Management Excellence Award in 2022!