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Contract Development and Manufacturing of Biopharmaceuticals

Polymun offers the production of biopharmaceuticals all the way from the gene to clinical grade material for innovator and biosimilar products. We offer process development and GMP production for all kind of recombinant proteins - antibodies, hormones, antigens, enzymes - from first-in-man projects up to market supply.

As small, independent and private company Polymun has no conflict of interests thus granting a high degree of flexibility and security for its clients including the possibility of technology transfer.

 

Our Services

ESTABLISHING OF PRODUCTION CELL LINES & CELL BANKS

- Development of high expression production cell lines using the BAC (bacterial artificial chromosome) technology in CHO cells
- Establishing of master cell banks (MCBs) and working cell banks (WCBs) under GMP conditions
- Organisation of cell bank qualification using qualified service providers
- Stability testing of cell banks
- Long term GMP storage of cell banks

PROCESS DEVELOPMENT: FERMENTATION, DSP & FORMULATION

- Development of fermentation processes with mammalian cell lines: fed-batch and perfusion
- Development of protein purification processes using chromatography of various kinds, filtration, precipitation
- Development of liquid formulations for long term storage of recombinant proteins

ANALYTICAL METHOD DEVELOPMENT

- Development of a broad range of analytic methods, including qualification and validation
Find here our list of analytical methods established for biopharmaceuticals.

GMP PRODUCTION

- Production of GMP material using mammalian cell lines, for clinical studies as well as for market supply
- Net fermentation volume for batch & fed-batch bioreactors: 1x 14 L, 1x 250 L, 2x 2500 L
- Net fermentation volume for perfusion: 1x 14 L, 1x 100 L
- Net fermentation volume for disposable bioreactor (WAVE, GE Healthcare): 1x 25 L

FILLING

- Manual filling of glass vials (2 mL to 20 mL) with up to 1,800 vials per fill
- Manual filling of plastic containers (various sizes and formats)
- Available soon: Automated filling line for glass vials (2 mL to 20 mL) with up to 10,000 vials per fill
- Available soon: Freeze-drying
- Validation of filling process by media fills

RELEASE AND STABILITY TESTING

- Release testing of drug substance and final drug products including release for human use by a Qualified Person according to EMA requirements
- Stability studies at various temperatures: -70 °C, -40 °C, -20 °C, 2-8 °C, 23-27 °C, 35-39 °C, 38-42 °C, photostability

CLINICAL & REGULATORY SUPPORT

Polymun has organised many clinical studies in various indications over a period of nearly 20 years. This expertise is now available as service for our customers for clinical and regulatory support.

SERVICES

  • Establishing of Production Cell Lines & Cell Banks
  • Process Development (Fermentation, DSP, Formulation)
  • Analytical Method Development
  • GMP Production
  • Filling
  • Release and Stability Testing
  • Clinical & Regulatory Support

GMP Production

MEET US AT

Controlled Release Society Annul Meeting
July 16-19, 2017

Boston, USA

Dr. Andreas Wagner
 

ILS Liposome Advances and Liposome Research Days
September 16-18

Athens, Greece

Dr. Andreas Wagner
Dr. Charalampos Koutsoulas