Biovian viral vector production

products-servicesBiovian Ltd
August 27th 2015

Biovian´s one-stop-shop ‘from early development to finished vial’ services include GMP compliant production of viral vectors. Biovian’s highly trained specialists and sophisticated facilities can perform development, manufacture, purification and characterization of viral products.

The range of Biovian facilities enable flexible production scenarios utilizing adherent cell based and suspension cell based processes.

Biovian can perform virus particle purification using classic ultra centrifuge-based processes or by using scalable chromatography.

GMP viral vectors

Biovian has extensive experience and knowledge in Viral Vector Production for gene therapy applications. The European Medicines Agency (EMA) has licensed Biovian to produce viral vector products for clinical trials as well as for commercial use.

Biovian has the capability to batch manufacture e.g. adenoviruses or lentiviruses according to cGMP standards. Biovian has produced cGMP virus material to support a number of successful clinical trials in the USA and EU.

Dedicated viral vector production facility

Biovian´s dedicated Viral Vector production facility provides the customer with wide choice and flexibility over production scenarios.

The facility offers a range of adherent cell based and suspension cell based processes. Vector purification is performed using classic ultracentrifugation or by chromatographic processes that are both disposable and highly scalable.

Ultracentrifugation

Biovian uses preparative ultracentrifuges generating accelerative forces to separate and purify viruses. After high speed spinning to produce separation, gradient solutions are gently pumped out of each tube to isolate the separated components.

Ultracentrifugation is a highly specialized process that requires great care and rigor to perform in safety because of the huge kinetic energy generated.

Scalable chromatography

Biovian has developed scalable and reproducible production methods based on chromatographic technology that can be used to yield purified adenovirus or lentivirus vectors for clinical trials. These systems can handle culture volumes up to 100 liters to produce batches supporting clinical trial batch manufacture.

Process utilizes disposable production technologies such as bioreactors, harvesting by depth filters to remove cells and cellular debris and chromatography to purify viruses. Disposable technologies minimize cleaning requirements and remove any possibility of product cross contamination.

Bioreactors

Biovian can also perform suspension cell-based cultivation in its Wave-bioreactor or adherent cell-based cultivation in a packed bed bioreactor.

Aseptic filling

Aseptic filling of formulated DS bulk into vials is the final and the most GMP-critical step in viral vector production. Biovian has in-depth expertise in very complex aseptic processes. Biovian can offer a full service from fill and finish to labeling and QP-release of batches for clinical trial purposes.

Biovian’s filling rooms are both equipped with fully disposable product contact parts. In house safety testing includes sterility testing, endotoxins and many product specific analysis, such as infectious titer, total VP, expression analysis and impurity analysis.

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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