Address: Donaustrasse 99, 3400 Klosterneuburg, Austria
Tel: +43 2243 25060 300
Fax: +43 2243 25060 399

Polymun Scientific Immunbiologische Forschung GmbH

Over more than two decades, Austria’s Polymun Scientific has established an impressive reputation for innovative contract development and high quality manufacturing of biopharmaceuticals as well as liposomal formulations of APIs and vaccine antigens.

Polymun’s core competences also include GMP-compliant biopharmaceutical manufacturing using mammalian and microbial cell technology. Polymun offers all steps from the gene to clinical grade material for patented and generic productsto supply clinical studies as well as the market.

Polymun operates in accordance with current GMP guidelines and holds an Austrian production license thus meeting all EU requirements for drug manufacturing. In addition, the US Food & Drug Administration (FDA) has inspected Polymunin October 2013.

Services

Polymun offers two principal lines of service.

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 offers all steps from the gene to clinical grade material for innovator and generic products.

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.

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.

Capacity:

Mammalian cells

  • Stirred tank: 15 l, 240 l, 2x 2500 l
  • Ultrasonic cell retention: up to 100 l continuous perfusion culture

Yeast / bacteria

  • Stirred tank: 50 l, 750 l

Downstream purification

  • process systems up to 600 l/h and 6 bar

The focus is on mammalian cell culture with a bioreactor capacity up to 2500 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 750 L. Polymun uses a standard purification scheme for antibody purification.

Bulk and end products can be manually filled in glass vials, syringes and infusion bags of various volumes in sufficient quantities for clinical studies in Polymun’s GMP laboratories. Contract manufacturing includes preparation of CMC parts for IMPD submission.

Polymun’s independent status as a private company means no conflict of interests, bringing greater flexibility and security for clients, including more technology transfer opportunities.

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:

  • Scalability
  • Sterility
  • Homogeneous, uniform vesicles
  • Entrapment of several product classes with high efficiency
  • Batch to batch consistency
  • Stability due to a mild procedure

Research Reagents

Polymun Scientific can directly supply a range of advanced research reagents in four relevant classes:

  • HIV Antibodies (16)
  • HIV Antigens (6)
  • Recombinant Human and Porcine Trypsin (2)

To learn more about Polymun products and services and how they can assist your business, please contact the supplier directly.



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Groups:
  • CRO, CMO, CRAMS & CDMO
  • Clinical Trials & Studies
  • Drug Delivery
  • Formulation & Ingredients
  • Manufacturing & Production