Cmo capabilities list june 2017

UK Contract Manufacturing Capabilities

BIO Convention, May 2017

San Diego, CA

To connect with any of the companies listed here, please contact

torrey.ah-tye@mobile.trade.gov.uk & kathryne.kirk@mobile.trade.gov.uk

Contents

Topical Treatments

3

Cell Therapies

5

Natural Products

6

Chemicals

7

Biologics

8

Vaccines

10

Formulation

11

Medical Device Manufacturing

13

Scale Up & Process Support

14

2

TOPICAL TREATMENTS

Company

Description Keywords: Skin & Wound Care, Infection Prevention, Oral Care

1 http://www.3m.co.uk/3M/en_GB/companyuk/?WT.mc_id=www.3m.co.uk

Description: 3M’s healthcare business offers products and solutions for health information systems, drug delivery and food safety. 3M Loughborough has facilities for manufacturing, supply chain management and distribution and R&D. They specialize in contract manufacturing of oral, topical and inhalation drug delivery systems. The state-ofthe-art cGMP compliant manufacturing in Loughborough, offers cold-fill capabilities.

Keywords: Transdermal technologies

2 http://www.aesica-pharma.com/

Description: Aesica, part of Consort Medical Group is renowned for developing and manufacturing both APIs and finished dose forms to the pharmaceutical industry. We are constantly developing the technical and analytical skills of our people to ensure that we are capable of meeting the ever-changing demands of our customers. Our offering is underpinned by our focus on quality, reliability and service, we are aware that customers want more than a supplier, which is why we work in partnership to provide a flexible, efficient and dependable service.

Keywords: Floor contamination control

3

https://www.dycem-cc.com/

Description: Dycem is the market leading manufacturer of polymeric contamination control flooring. Our CleanZone & WorkZone floor mats, placed at entrances, gown rooms & transfer areas, are scientifically proven to reduce foot and wheel-borne contamination by up to 99.9% and reduce air-borne particulate by up to 75%.

Our unique, anti-microbial, polymeric composition, is 3x more effective at trapping and retaining particles than peel-off tacky mats and is the only solution for heavy wheeled traffic such as forklifts and motorized pallet jacks.

Keywords: GMP MHRA, Veterinary Medicines Directorate Description: Manufactures topical applications: Kaolin Poultice BP and Magnesium Sulfate Paste BP Contract manufacturer for fill creams, lotions, ointments and liquids. Includes small or test runs.

4 http://www.hfweb.co.uk/klpharm/

3

Keywords: Transdermal technologies

5 http://www.medpharm.co.uk/

Description: MedPharm is the world leading contract development organization for topicals and transdermal pharmaceutical products headquartered in the UK and with development sites in the UK and US. MedPharm provides innovative guidance to clients to help them navigate the complex process of development in these specialist areas. MedPharm can support customers from API selection to GMP clinical manufacture. Its market leading performance models help optimize formulation development, support bio-waiver submissions, and generate data that regulators and investors know they can trust.

Keywords: Topical Pain Relief

6 mentholatum.co.uk

Description: Mentholatum, specialises in family healthcare producing the UK’s No.1 selling pain relief heat and freeze brands, helping people manage muscular and joint pain. Mentholatum also produce non-medicinal and food supplement products to help support active lives, sporting lives and later in life.

4

CELL THERAPIES

Company

Description Keywords: Description: The Cell and Gene Therapy Catapult's mission is to improve the cell and gene therapy sector in the UK. The company focuses on the growth of the industry by helping cell and gene therapy organizations to translate early stage research into commercially viable and investable therapies.

1 https://ct.catapult.org.uk/

Keywords:

2 http://www.miltenyibiotec.com/en/

Description: Miltenyi Biotec provides products and services for biomedical research and cellular therapy. The company develop and manufacture a portfolio of products ranging from unique cell labeling reagents, through sophisticated cell separation and analysis devices, to innovative systems for clinical applications. The company's integrated technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, cell culture, molecular analysis, and preclinical imaging.

Keywords: Cell based therapies, ATMPs

3 www.roslincells.com

Description: Roslin Cell Therapies is a leader in the development and manufacture of cell-based therapies and ATMPs. The company provides integrated and custom-designed product development and manufacture service solutions for cellular therapies intended for clinical trials.

Keywords: Cell therapy process management, Supply chain integration technology, Regenerative therapies

4 https://trakcel.com/

Description: TrakCel is an orchestration platform to safeguard patients being treated with regenerative therapies.

The platform ensures that the right patient receives the right therapy at the right time and location. TrakCel arranges the movement of the patient’s/donor’s cellular starting material from the patient to a processing/manufacturing facility and back to the patient for engraftment.

5

NATURAL PRODUCTS Company

Description Keywords: Commercial-scale generic and custom omega API production, cGMP-certified facility, pharmaceutical supply, nutraceutical supply, research supply innovative separation, purification methods

1 http://omega3.basf.com/web/global/o mega3/en_GB/

Description: Purifies omega-3 fatty acids from fish oil as Active Pharmaceutical Ingredients (APIs) for pharma companies to a high degree of purity, minimises undesirable by-products and uses less energy than the high temperature distillation. Highly concentrated omega oils (up to 99 percent purity in a single lipid) Keywords:

2 http://www.collagensolutions.com/

Description: Collagen Solutions Plc is a global provider of medical grade collagen formulations and components for use in regenerative medicine, medical devices and in-vitro diagnostics. Our capabilities include the provision of native, soluble and powdered collagen formulations and expertise in the development and contract manufacture of collagen components for use as tissue scaffolds and medical devices.

6

CHEMICALS

Company

Description Keywords: Small molecule, Agrochemical

1 www.calachem.com

Description: Contract manufacturing and site services (at Grangemouth) to customers in the agrochemical, pharmaceutical and specialty chemical industries. 5 plants within Grangemouth from pilot to large scale manufacture.

Keywords: Alkaloid opiates, Controlled drugs

2

www.macsmith.com

Description: Macfarlan Smith Limited, part of Johnson Matthey PLC's Fine Chemicals Division, is a world leader in the production of alkaloid opiates and other controlled drugs.

Keywords: API manufacturing Description: The Pharma Solutions Morpeth site is one-of-a-kind US FDA and UK MHRA approved facility having API Blocks with reactor scale of 50 – 2500 litres. The site also support Small scale API manufacturing of prostaglandins

3 http://www.piramal.com/pharmasolutio ns/about-us/global-network/morpeth/

7

BIOLOGICS

Company

Description Keywords:

1 www.almacgroup.com

Description: Scottish site responsible for contract peptide manufacture. Includes immunograde peptides for making antibodies as well as chemokines, defensins histones. Peptides can be modified and conjugated, GMP production, First in human, Scale 10mg to 0.5kg for peptides up to 200 amino acids in length, Company has extensive ADC experience Keywords: Cell bank manufacturing Description: The company offers testing, development and manufacturing services to the pharma and bio-pharma companies, including master and working cell bank manufacturing.

2 http://www.bioreliance.com/

Keywords: Opthalmology, Aesthetic Dermatology, Orthapedics Description: Hyaltech has a proprietary bio-fermentation platform for the production and purification of medical grade hyaluronic acid (HA). Hyaltech was the first company to combine HA with ancillary lidocaine for an easy workflow in cataract surgery and more patient comfort. We were pioneering managing the filling and handling of two different HA solutions in a double chamber syringe. Manufacture to GMP. Hyaltech‘s manufacturing plant is ISO 9001 and ISO 13485 compliant.

3

http://hyaltech.inarbeit.org/index.php?i d=1

8

Keywords: Proprietary synthetic biology

4 www.ingenza.com

Description: The company has a broad customer base within the chemicals, pharmaceuticals, food, feed and fuel industries where it applies its proprietary synthetic biology to manufacture chemicals, biologics, pharmaceuticals and biofuels. Business model is co-development with strategic partners or out license of proprietary process.

Keywords: Custom protein design, surface applications Description: Since its foundation in 2003, Orla Protein Technologies has built a solid reputation in the Life Sciences Industry through cutting-edge research and a commitment to innovation. We focus upon recombinant protein design, engineering and manufacture particularly for surface applications.

5

http://www.orlaproteins.com/

9

VACCINES Company

Description Keywords:

1 http://www.bioreliance.com/

Description: Scottish site responsible for contract peptide manufacture. Includes immunograde peptides for making antibodies as well as chemokines, defensins histones. Peptides can be modified and conjugated, GMP production, First in human, Scale 10mg to 0.5kg for peptides up to 200 amino acids in length, Company has extensive ADC experience Keywords: Montrose - APIs, Vaccines, Manufacturing materials for respiratory medicine, Producing aluminum adjuvants for vaccines

2

Description: This adjuvant production at Montrose is the first time that UK involved in GSK's vaccine supply chain http://uk.gsk.com/en-gb/

Keywords: Flu, Pseudomonas, Lyme disease vaccines

4 http://www.valneva.com/en/

Description: GMP manufacturing facility in Livingston capable of producing in excess of 1 million doses per year: Dedicated to the production of the Japanese Encephalitis vaccine. Proprietary cell line to manufacture human and animal viral vaccines. Proprietary adjuvant IC31 available for out licensing.

10

FORMULATION Company

Description Keywords: Cytotoxic, ADC’s

1 http://amriglobal.com/about/AMRI_Gl asgow_26_129_sb.htm

Description: The 30,144 ft² facility in Glasgow, UK, has world-class sterile fill/finish and formulation development capabilities; development laboratories, liquid and lyophilized GMP manufacturing suites; and a dedicated cytotoxic manufacturing suite for liquid and lyophilized products.

Keywords: MIA(IMP) License, Packaging development

2

http:// www. biofilm .co.uk

Description: BioFilm has established an excellent reputation for developing and manufacturing thin dissolvable films (TDF) which release active ingredients.

/

Keywords: DNA, Viruses, Protein, Microbiota, Fill Finish

3

http:// www. cobra bio.c om/

Description: Cobra provides a comprehensive biologics and pharmaceuticals service offering, with multi-functional and experienced project teams nurturing customers’ products from pre-clinical through to clinical and commercial manufacture within three GMP approved facilities.

11

Keywords:

4 http://www.fmcbiopolymer.com/

Description: Global market leader for supplying well-characterized cellulosic, carrageenan and alginate products.

Formulation solutions around their expertise in excipients to improve bioavailability, enhance sensory aspects, enable controlled release, and facilitate processing efficiencies. Offers troubleshooting advice and training.

Applications include Pharmaceutical, personal care, water treatment and food and drink. Manufacturing facility in Girvan.

Keywords: Transdermal technologies

5 http://www.medpharm.co.uk/

Description: MedPharm is the world leading contract development organization for topicals and transdermal pharmaceutical products headquartered in the UK and with development sites in the UK and US. MedPharm provides innovative guidance to clients to help them navigate the complex process of development in these specialist areas. MedPharm can support customers from API selection to GMP clinical manufacture. Its market leading performance models help optimize formulation development, support bio-waiver submissions, and generate data that regulators and investors know they can trust.

Keywords: Development, Manufacturing, packaging, supply and testing of Oral Solids formulations

6 http://www.piramal.com/pharmasolutio ns/about-us/global-network/morpeth/

Description: The Pharma Solutions Morpeth (US-FDA & UKMHRA approved) site located 300 miles north of London, provides development and manufacturing services right from clinical to commercial level. Site is specialized in handling Hormonal products and press coated technology. Piramal can support Clinical trial supply services with a proprietary web based tool, TrakPack, to track clinical kit status.

Keywords: Hodgkinson’s lymphoma, optimization and characterization, Preclinical and toxicology batch preparations, Analytical and bio-analytical method development and validation, Proof of Concept studies

7 http://www.piramal.com/pharmasolutions/abo ut-us/global-network/grangemouth/

Description: Multi-Product manufacturing facility characterized by dedicated or single use product-contact manufacturing components with high containment capabilities It is the first ever to offer CMO services in the field of ADC. With over 10 years of extensive experience in this field, the site covers all major ADC drug classes and linker chemistries (over 460 batches (>240 GMP batches) of ADCs spanning more than 60 distinct ADC candidates).

Keywords: Clinical trials supplies, Phase I, Phase II, injectable Description: The company offers contract manufacturing of novel injectable pharmaceuticals for use in Phase I and II clinical trials. They specialize in cGMP manufacture of liquid, lyophilized, cytotoxic, conventional and biological pharmaceuticals.

8

http://www.symbiosis-pharma.com/

12

13

MEDICAL DEVICE MANUFACTURING Company

Description Keywords: Solid Works, Unigraphics (NX), Advanced CAM processing, Manufacturing solutions for developing new product, Volume production.

1

Description: Sheffield Precision Medical is the leading UK orthopedic instrumentation solutions provider, and has developed a global reputation for partnering with OEM implant manufacturers. http://www.sheffieldpm.co.uk/about.h tml

14

SCALE-UP & PROCESS SUPPORT Company

Description Keywords:

1 http://www.eppltd.com/

Description: Edinburgh Pharmaceutical Processes Ltd is a provider of synthetic and analytical chemical services for pharma and agrochemical. The company core products and services include: Bulk active manufacturing for nonclinical applications, and R&D of the manufacturing process for scale up.

Keywords: Proprietary synthetic biology

2 www.ingenza.com

Description: The company has a broad customer base within the chemicals, pharmaceuticals, food, feed and fuel industries where it applies its proprietary synthetic biology to manufacture chemicals, biologics, pharmaceuticals and biofuels. Business model is co-development with strategic partners or out license of proprietary process.

Keywords: Transdermal technologies

3

http://www.medpharm.co.uk/

Description: MedPharm is the world leading contract development organization for topicals and transdermal pharmaceutical products headquartered in the UK and with development sites in the UK and US. MedPharm provides innovative guidance to clients to help them navigate the complex process of development in these specialist areas. MedPharm can support customers from API selection to GMP clinical manufacture. Its market leading performance models help optimize formulation development, support bio-waiver submissions, and generate data that regulators and investors know they can trust.

Keywords: Flu, Pseudomonas, Lyme disease vaccines

4 http://www.valneva.com/en/

Description: GMP manufacturing facility in Livingston capable of producing in excess of 1 million doses per year: Dedicated to the production of the Japanese Encephalitis vaccine. Proprietary cell line to manufacture human and animal viral vaccines. Proprietary adjuvant IC31 available for out licensing.

15