Polymun Scientific

Contract Development and Manufacturing of Biopharmaceuticals and Liposomal Formulations

Polymun Scientific

Polymun Scientific GmbH is a family-owned company in Klosterneuburg, Austria, founded in 1992. Our core activities are contract development and GMP manufacturing of biopharmaceuticals as well as liposomal formulations of APIs and vaccine antigens - for clinical studies and the market.

Revenues are invested in own R&D projects and the further development of technology platforms. Polymun operates in accordance with current GMP guidelines and holds an Austrian production license thus meeting all EU requirements for drug manufacturing. In addition, Polymun's facility is accepted by the US FDA.

Polymun employs a team of about 75 dynamic and highly qualified scientists, technologists and support staff. With quality and reliability as a pre-requisite basis, innovation and creativity are strongly encouraged at Polymun. We are a flexible partner focused on the requirements of our clients.

Contract development and GMP 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 has gathered experience in designing purification processes for proteins of all kinds - antibodies, hormones and enzymes. A wide range of analytical methods is available and 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 and organisation of clinical studies.

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: 14 l, 250 l, 2x 2500 l
  • Ultrasonic cell retention: up to 100 l continuous perfusion culture
  • Disposable bioreactor (WAVE, GE Healthcare): 1x 25 L

Yeast / bacteria

  • Stirred tank: 50 l, 750 l

Downstream purification

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

Contract development and GMP 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 studies.

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

Contact Details

Polymun Scientific GmbH
Donaustr. 99
3400 Klosterneuburg
Austria
+43 2243 25060 300
+43 2243 25060 399
office@polymun.com
www.polymun.com

Available White Papers

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Liposome Technology 08 December 2016 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 with a non-invasive application. A liposomal formulation can clearly improve the therapeutic index of your drug.

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Contract Development and Manufacturing by Polymun - Biopharmaceuticals and Liposomal Formulations 02 June 2016 Contract Development and Manufacturing by Polymun - Biopharmaceuticals and Liposomal Formulations