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Phone: +43 2243 25060 300
Fax: +43 2243 25060 399
- Development and manufacturing of biopharmaceutical under GMP-conditions for clinical studies as well as for the market with focus on mammalian cell technology but also microbial cell technology – as contractor and for own R&D projects.
- Development and manufacturing of liposomal formulations under GMP-conditions for clinical studies as well as for the market – as contractor and for own R&D projects.
Contract Services offered:
Contract Development and Manufacturing of Biopharmaceuticals
The core competence of Polymun is the development and GMP-compliant manufacture of biopharmaceuticals, using both mammalian and microbial cell technology. Polymun holds a pharmaceutical production license under paragraph 63 of the Austrian Pharmaceutical Law, thus fulfilling all EU regulations, and is inspected by FDA. Polymun offers all steps from the gene to clinical grade material for innovator and generic products. Polymun has gathered experience in designing purification processes for proteins of all kinds - antibodies, hormones and enzymes. A wide range of analytical methods is available that can be readily adapted to new requirements. GMP-compliance and industrial applicability are central to all operations. Contract manufacturing includes the preparation of IMPD and CMC documents. Based on our own experience we are able to support planning of phase I-III clinical trials. 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.
Mammalian cell culture:
- batch, fed-batch: 1x 14 L (seed bioreactor), 1x 250 L, 2x 2500 L
- perfusion: 1x 14 L (seed bioreactor), 1x 100 L
- 1x 25 L (WAVE, GE Healthcare)
- Stirred tank: 50 L, 750 L
- Process systems up to 600 L/h and 6 bar
Contract Development and Manufacturing of Liposomal Formulations
Liposomes protect, transport and release your drug at the right place and time. By this, a reduced dose achieves better efficacy and avoids side effects by a non-invasive application. Polymun offers the development of liposomal formulations for all kinds of active pharmaceutical ingredients and vaccine antigens. We manufacture GMP-material including all necessary documentation and assist in planning of clinical trials. License agreements for Polymun’s patented liposome production technology are offered for the respective substance on an exclusive basis. Contracts can be arranged step by step - proof of concept, in-depth analysis, GMP-material production, product license - or all in one. Industrial applicability is the focus throughout each project. Polymun’s technology enables the industrial realization of pharmaceutical and cosmetic products for liposomal drug formats. The production technology is suitable for a broad range of substances formulated by passive entrapment, active loading or membrane incorporation.
Main characteristics of our technology are:
- Homogeneous, uniform vesicles
- Entrapment of several product classes with high efficiency
- Batch to batch consistency
- Stability due to a mild procedure
Own R&D Projects:
Human Monoclonal Antibodies against HIV-1
Polymun has established three human monoclonal antibodies (C2F5, C2G12 & C4E10) produced in recombinant CHO cells for therapeutic or prophylactic treatment of HIV-1 patients. Clinical phase I trials have been completed successfully as well as two phase II trials, one at the university hospital in Zurich and the other in New York (Aaron Diamond Aids Research Center, Dr. Markowitz) under IND of the FDA. Another phase I clinical trial was performed within the EU-project EMPRO using the antibodies as a vaginally administered microbicides in a gel formulation.
Polymun has incorporated human recombinant Cu/Zn-Superoxiddismutase (SOD) into liposomes. The concept of transdermally administered SOD as a radical scavenger for the treatment of inflammations has manifold possibilities; quasi as an alternative to cortisone treatment, but free of any adverse effects.
Polymun finished a phase III clinical trial for the transdermal application of LipoxysanTM in human volunteers suffering from IPP (Induratio Penis Plastica) successfully. Polymun is planning trials for other indications, such as atopic lung- and bronchial inflammation as well as heat- and UV-burns. In May 2015, Polymun has signed a license agreement with ScarletRed for development and marketing of SOD.
Porcine Recombinant Trypsin
Polymun has developted a proprietary recombinant porcine trypsin production system that is autocatalytically activated to the active enzyme. This product is used to replace trypsin of animal origin. It has defined activity (e.g. free of chymotrypsin activity without inhibitor treatment) and is free of tissue born contaminants.
Polymun has signed a license agreement with Richcore Enzymes Pvt Ltd (Bangalore, India) for the recombinant porcine trypsin technology. Richcore is manufacturing this recombinant porcine trypsin in large scale kilogram quantities for use in GMP processes.
Last update of this entry: November 06, 2018