POLYMUN SCIENTIFIC GmbH Profile

The core activities of Polymun Scientific GmbH are contract development and manufacturing of biopharmaceuticals as well as liposomal & lipid nanoparticle formulations of APIs and vaccine antigens. Founded in 1992, Polymun is located in Klosterneuburg, next to Vienna, Austria, with currently 100 employees.

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 is inspected by FDA (October 2013). 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.

 

Biopharmaceuticals

The core competence of Polymun is the development and GMP-compliant manufacture of biopharmaceuticals, using mammalian cell technology. Polymun offers all steps from the gene to clinical grade material for innovator and generic products.

We see vector, production cell line, cell banking, processes for fermentation and purification as well as analytical methods as parts of a networked development in order to achieve optimal results. Entirely new projects as well as missing elements of existing processes can be custom designed. 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 in-house experience Polymun is able to support planning of phase I-III clinical trials.

Upstream (net fermentation volumes)

• Stirred tank: 15 l, 250 l, 2x 2500 l
• Ultrasonic cell retention: up to 100 l continuous perfusion culture
• Disposable bioreactor: 1x 25 L

Downstream purification: process systems up to 600 l/h and 6 bar

Liposomal & lipid nanoparticle 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 & lipid nanoparticle 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.

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 products for liposomal and lipid nanoparticle 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

Filling

• Manual filling of glass vials (2 ml to 20 ml) with up to 2,000 vials per fill
• Manual filling of plastic containairs (various sizes and formats)
• Automated filling line for glass vials (2 ml to 20 ml) with up to 10,000 vials per fill
• Freeze-drying (4000 2 ml vials or 1200 20 ml vials)
• Validation of filling processes by media fills