POLYMUN Scientifc Immunbiologische Forschung GmbH

Nussdorfer Laende 11
A 1190 Vienna, Austria
Austria

Phone: +43 1 36006 6203
Fax: +43 1 3697615

Description:

Core competences

– 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 also a pharmaceutical production license under paragraph 63 of the Austrian Pharmaceutical Law, thus fulfilling all EU regulations. 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. Each step can be operated with protein-free cryopreservation and cell culture media. 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.
Capacity:
– Stirred tank: 15 l, 200 l, 1750 l
– Ultrasonic cell retention: up to 100 l continuous perfusion culture
– Air lift: 550 l
– Fluidized bed: 30 l carrier volume
– Downstream purification: 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 or substances for cosmetic application. 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