Mammalian Cell Based Production of Biopharmaceuticals

Overview

Biovian is a specialist in cGMP contract manufacturing of mammalian cell-based APIs and drug substances. Biovian’s2,300 square meter EMA and FDA certified facilities in Turku, Finland includes a separate GMP-compliant 5-500 liter pre-clinical to clinical scale mammalian production unit.

This comprises state-of-the art bioreactors, harvesting equipment and several downstream suites and equipment to allow flexible production of therapeutic grade recombinant proteins and monoclonal antibodies, using batch-, fed-batch and perfusion mode cultivations.

Biovian’s production facilities includes also dedicated production units for gene therapy products and microbial production.

Upstream Processing (USP)

Biovian can offer working volume capacity up to 100 L in its disposable BioWave reactor and up to 500 L capacity in its disposable stirred tank bioreactor mammalian cell cultivation.

USP Harvesting is conducted by depth filtration or by tangential flow filtration units for harvest clarification and further processing.

Downstream Processing (DSP)

Biovian’s comprehensive downstream purification solutions include low pH inactivation, conventional chromatography, membrane based chromatography and filtration processes including also tangential flow filtration and nano filtration processes.

Aseptic Fill & Finish

Biovian can offer advanced aseptic fill/finish and lyophilization of glass vials at pre-clinical and clinical scale, for formulation and final drug product manufacture.

Two automated filling lines can handle batch sizes ranging from 200 to 7,000 vials while lyophilization provides freeze-drying preservation of therapeutic proteins, etc. Combined with Biovian’s expertise in master cell banking, these facilities are key to ensuring successful clinical development and manufacturing as well as a commercial supply phase for biologicals, using a master cell line as the basis for the working cell bank driving smooth scale up to high quality production.

Viral vector production

Biovian´s dedicated viral vector production facilities enable flexible production scenarios utilizing adherent cell based and suspension cell based processes. Virus particle purification can be performed by classic ultracentrifuge-based processes or byscalable chromatography based process.

Analytics

Biovian production of drug substances and products for release is supported by integrated analytical Quality Control services that comply with the European and U.S. Pharmacopoeias (Ph. Eur. and USP).

QC and analytical services include product-specific assays, impurity analysis, cell-based assays, microbiological QC and safety assays that include sterility, bioburden and endotoxins.

Resources

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Supplier Information
Supplier: Biovian Ltd
Address: Tykistökatu 6B, Biocity FIN-20520 Turku, Finland
Tel: +358 2 27488 77
Fax: +358 2 27488 41
Website: www.biovian.com