Contract Manufacturing Biopharmaceuticals
Polymun operates a GMP-compliant pilot plant for the production of clinical grade material. Entirely new projects as well as missing elements of existing production processes can be custom designed via contract development.
The focus is on mammalian cell culture with a bioreactor capacity up to 1750 L. Batch, fed-batch, continuous and continuous perfused systems are used for suspension and adherent cell lines according to the process needs. The fermentation capacity per batch for microbial cell culture is up to 50 L. Polymun uses a standard purification scheme for antibody purification. This scheme is applied routinely, e.g. for our HIV antibodies which have been under clinical evaluation under IND of the FDA.It is possible to manually fill bulk and end products in infusion bags, syringes and glass vials of various volumes in sufficient quantities for clinical studies in our GMP laboratories. Contract manufacturing includes the preparation of the CMC part for IMPD submission.
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.
Fermentation Capacity
Mammalian Cells:stirred tank: 15 L, 240 L, 2x 2500 L
continuous perfusion culture: 100 L (ultrasonic cell retention)
Yeast / Bacteria:
stirred tank: 50 L, 750 L
The European Commission is acknowledging Polymun's competence by listing the large scale manufacture of mAb in protein free media as the opening example in its booklet: 100 Technology Offers stemming from EU Biotechnology RTD results.
For Finox AG, Polymun developed a manufacturing process for recombinant human follicle-stimulating hormone (rhFSH) as biosimilar. A phase I study was completed successfully with GMP material manufactured by Polymun, the phase III study is ongoing.
In 2008, Polymun was performing a part of the manufacturing process (fermentation of recombinant bacteria) of GMP-material for a multi-valent recombinant outer surface protein A (OspA) Lyme Borreliosis Vaccine for Baxter Innovation GmbH.
An agreement has been signed with GeNeuro SA, Switzerland, for the cell line development and GMP-compliant manufacturing of a monoclonal antibody for the treatment of multiple sclerosis.
Polymun has signed a contract manufacturing agreement with Apeiron Biologics for its lead project APN01. A GMP production process was established for the recombinant human soluble ACE2 in CHO cells. Clinical development was started with the GMP material manufactured by Polymun.
After the APN01 project of Apeiron was assigned to GlaxoSmithKline, GSK contracted Polymun for further process development and manufacturing of clinical trial supply
Polymun is contract manufacturer of a recombinant gp140 HIV envelope protein for St George's, University of London in the context of a project of the Grand Challenges in Global Health. This Mucosal HIV Vaccine Project under the lead of Dr. Robin Shattock is focusing on novel antigen design and delivery for mucosal protection against HIV-1 infection.
Polymun has developed a CHO cell line as well as fermentation and purification processes for the production of recombinant human erythropoietin (EPO). Six consecutive industrial batches have been manufactured under GMP conditions. Phase I studies were performed successfully in Austria. Polymun is free to sell EPO and to market the manufacturing technology.
Polymun established a CHO production cell line for the chimeric monoclonal antibody ch14.18 and manufactured GMP-compliant material for a European-wide clinical study for the treatment of neuroblastoma. This study is under the chair of Dr. Ruth Ladenstein, St. Anna Children's Hospital, Children's Cancer Research Institute.
For Baxter International Inc. Polymun is manufacturing the mouse monoclonal antibody HPC4 which is used for the affinity purification of protein C (Ceprotin®).