Accelerate biotechnology

Pre-clinical manufacturing

Your research is only valuable if your data can be reproduced. It is therefore crucial that high quality, well-characterized research materials for your pre-clinical studies are used. Our capabilities and experience qualify us to be your research partner and deliver your viral vaccines.

We are very experienced in growing wildtype and attenuated viruses on mammalian cell lines in adherent, microcarrier-based, or suspension cell culture. Hereto, we have a variety of cell lines at our disposal, such as modified, cloned, or parental Vero, MRC-5, and MDCK cell lines. Using these platforms, we manufacture a wide range of viruses including polio, measles, rubella, influenza and rotavirus. We can utilize a range of different manufacturing scales for pre-clinical manufacturing ranging from high-throughput 20 mL spin tubes up to 200 L bioreactors. The equipment ranges from shake flasks and cell factories to WAVE Bioreactors™, iCELLis® equipment, and scale-X™ high cell density bioreactor. The different upstream scales are matched with appropriately scaled downstream equipment for clarification, concentration, chromatography and filtration. For the purification of viruses, we offer clarification by depth filtration with a variety of different filters including filters that combine particle purification and impurity removal. Removal of nucleic acids is often required for viral products and can be achieved by techniques such as enzymatic digestion or fractional precipitation. Prior to purification, concentration and buffer exchange using tangential flow filtration can be performed using hollow fibers or flat screens. This is dependent on the physical properties of the target virus and the requirements of the final product.

Purification is normally achieved using several chromatography steps. The type of chromatography used is dependent on the virus properties. Commonly for purification, ion-exchange or hydrophobic interaction differences are exploited. For polishing and formulation, size-based group separation or tangential flow filtration can be used, be it hollow fibers or flat screens. Depending on the size of the viral product, a sterile filtration can be performed. For larger viruses for which this approach is not feasible, we have extensive experience in validated aseptic manufacturing processes. For analysis of the product, we offer a variety of product specific assays and assay development services, such as TCID50, PFA, FFA, ELISA, (q)PCR and HPLC-based methods.

Pre-clinical manufacturing track record

Our broad experience with viral vaccine production and process development (production media screening, multiplicity of infection determination, day of harvest, etc.) as well as the availability of assays to demonstrate aspects such as yield, purity, integrity, infectious versus empty particles allows us to deliver a complete package of purified vaccine, together with associated biochemical and analytical characterization data. We have successfully delivered diverse vaccines for preclinical studies including- but not limited to- hepatitis A, influenza, rhinovirus, Sabin polio, Salk polio and RSV.

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Process development

Clinical manufacturing

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