Contract Development of Biopharmaceuticals

Polymun can establish biopharmaceuticals all the way from development of source gene to production of clinical grade material for innovator and biosimilar products.

Polymun’s methodology treats vector, production cell line, fermentation processes, purification and specific analytics as interlinked components in a networked development matrix. Coordinating these elements in a holistic approach achieves optimal industrial implementation.

Contract development capabilities

Polymun has well-established experience in converting scientific identification of new biopharmaceutical substances into industrial processes. Examples from Polymun′s own R&D projects include HIV antibodies for mammalian cell culture and superoxide dismutase (SOD) for microbial cell culture.

Polymun uses a comprehensive system of documentation and quality necessary for clinical evaluation and is able to provide support for planning clinical trials phase I-III, again based on its own experience. Coherent GMP documentation and on-site training of key personnel speeds final transfer of the process to the client.

Case studies

Polymun has been involved in a number of successful recent and on-going biopharma development and production projects.

• For Finox AG, Polymun developed a manufacturing process for recombinant human follicle-stimulating hormone (rhFSH) as biosimilar. Now, Polymun is manufacturing rhFSH as API for the final product of Finox AG (Bemofa®) licensed for the EU market.
• 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 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 Imperial College Londonas part of the UK HIV Vaccine programme. This programme 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 to produce recombinant human erythropoietin (EPO), manufacturing severalconsecutive industrial batches under GMP conditions.

Development process

Next to optimal production premises, the absence of third party IP-rights is an important criterion in initial vector construction.

When it comes to establishing production clones and cell banks for low cost cell culture media free of proteins and animal-derived components, high and stable productivity as well as favorable growth properties are both important.

Polymun has developed a wide range of analytical tools for screening and has two separate GMP laboratories for establishing master and working cell banks. Cell bank qualification is performed in collaboration with certified QC laboratories.

Process Development for Fermentation

The most suitable process is selected from a choice of batch, fed-batch and continuous perfused high cell density systems, using stirred tank bioreactors.

The medium is adjusted for the individual production clones. Polymun places high priority on scalability and robustness.

Downstream Processing

Downstream process development is a strong technology platform for Polymun, which aims to compose a process from a broad spectrum of methods that is optimal in terms of yield, product purity, virus clearance but also scalable and inexpensive. Transfer from lab through pilot scale to industrial scale is given special consideration, based on extensive experience in manufacturing.

Polymun uses a standard purification scheme for antibodies. This scheme is routinely applied.

Production of Preclinical and Clinical Material

Polymun can produce initial amounts of protein to lab scale at an early stage for preclinical evaluation. It can manufacture GMP-compliant material in its GMP plant for clinical evaluation.

Resources

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Supplier Information
Supplier: Polymun Scientific Immunbiologische Forschung GmbH
Address: Donaustrasse 99, 3400 Klosterneuburg, Austria
Tel: +43 2243 25060 300
Fax: +43 2243 25060 399
Website: www.polymun.com/