Polymun Scientific - Biopharmaceutical and Liposomal Manufacturing and Contract Development

Polymun Scientific is a family-owned company in Vienna, Austria, founded in 1992. Our core activities are contract development and manufacturing of biopharmaceuticals, as well as creating liposomal formats of drugs for contract partners.

The resulting revenues are invested in our own R&D projects and the further development of technology platforms. Polymun operates in accordance with current GLP, GMP and GCP guidelines, and holds an Austrian production license, thus meeting all EU requirements for drug manufacturing.

Polymun employs a team of about 40 dynamic and highly-qualified scientists, technologists and support staff. 60% hold an academic title, mostly in natural sciences such as biotechnology, biology or chemistry. About one-third have graduated at technical schools or colleges.

With quality and reliability as a pre-requisite basis, development and creativity are strongly encouraged at Polymun. We are a flexible partner focused on the requirements of our clients.

MAMMALIAN AND MICROBIAL-CELL BIOPHARMACEUTICAL MANUFACTURE

Polymun's core competence is the development and GMP-compliant manufacture of biopharmaceuticals, using both mammalian and microbial cell technology.

Polymun offers all process steps from the gene to clinical-grade material for innovator and generic products. We see vector, production-cell line, cell banking, and processes for fermentation and purification, as well as analytical methods, as parts of a networked development, thus ensuring we achieve the 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 a 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).

Product capacities:

• Stirred tanks of 15L, 200L and 1,750L
• Ultrasonic cell-retention of up to 100L continuous-perfusion culture
• Air lift of 550L
• Fluidised beds of 30L carrier volume
• Downstream purification process systems up to 600L/h and 6bar

LIPOSOMAL FORMULATIONS

Liposomes protect, transport and release your drug at the right place and time. A reduced dose therefore achieves better efficacy and avoids side effects through 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 and product license – or all in one. Industrial applicability is the focus throughout each project.

Polymun's technology enables the industrial realisation 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.

The 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)