Meridian Life Science – contract R&D, cGMP clinical manufacture, baculovirus expression vector system, BEVS, Parvovirus B19 vaccine, Sf9 cell culture

Meridian Life Science, Inc. is a world leader in the use of the Baculovirus Insect Cell Expression Vector System for the production of recombinant proteins such as Virus-Like Particles for vaccine products.

Baculovirus Expression Vector System:

Experience with Sf9 cell culture and cell banking
Baculovirus banking
Cell culture optimization and multiplicity of infections (MOI) studies for optimal yield
Experience with difficult co-infection strategies Two and three baculoclone co-infection modes Using different MOI's to control variable expression of multiple proteins
Experience with purification of Virus-Like Particles Column chromatographic purification trains Filtration (TFF, DF) and centrifugation methods

Case Study in BEVS:

Parvovirus B19 Vaccine:
Meridian Life Science has manufactured, and subsequently licensed, a recombinant Parvovirus B19 vaccine under a contract from the National Heart Lung and Blood Institute of the National Institutes of Health. The vaccine was manufactured according to cGMP in Meridian Life Science's fully qualified Spodoptera Frugiperda (Sf9) insect cell line and is now in Phase I/II safety/efficacy trials. The vaccine consists of two viral proteins (VP1 and VP2) in separate Baculovirus vectors that are co-infected at the correct MOI's into Sf9 cells and that, upon expression, self assemble into immunogenic virus-like particles. Meridian Life Science has a validated cGMP vialing line for this product of up to 2,500 vials.

Quality Systems and Testing Services	Test Method and Assay Development	Upstream Cell Culture Optimization
Viral Vaccines, Gene Therapies, Virus-Like Particles and Recombinant Proteins (BEVS)