Polymun Scientific

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.

The focus is on mammalian cell culture with a bioreactor capacity up to 1750 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 50 L. Polymun uses a standard purification scheme for antibody purification. This scheme is applied routinely, e.g. for our HIV antibodies which have been under clinical evaluation under IND of the FDA. 

It is possible to manually fill bulk and end products in infusion bags, syringes and glass vials of various volumes in sufficient quantities for clinical studies in our GMP laboratories. Contract manufacturing includes the preparation of the CMC part for IMPD submission. 

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. 
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Locations


Austria
Polymun Scientific Immunbiologische Forschung
Nußdorfer Lände 11
Wien,   1190
Austria, Europe

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Production Lines

Polymun Scientific Immunbiologische Forschung   Mammalian Cell Culture
Location: Wien, Austria
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  100L-2000L1750L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  AllAll
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is Not AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 18JUN14

Send Inquiry about this Production Line
Polymun Scientific Immunbiologische Forschung   Microbial Cell Culture
Location: Wien, Austria
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Scale:  1L-100L50L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  AllAll
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is Not AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 18JUN14

Send Inquiry about this Production Line

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