Your pre-clinical research is only valuable if your data can be reproduced, which requires the use of high quality and well-characterized research materials. Our capabilities and experience qualify us to be your research partner and deliver your viral vector products.
The generation of a novel viral vector batch is initiated by the molecular cloning of the gene of interest into the vector backbone. This can be achieved by traditional cloning methods or by DNA synthesis. All our plasmid stocks are quality controlled by restriction enzyme analyses, PCR assays, and DNA sequencing. Plasmids are amplified and then stored at -20°C. Depending on the vector to be manufactured, up to 4 plasmids are mixed and transfected into appropriate cell lines. We have experience with a variety of DNA transfection protocols including the use of electroporation-, chemical- or lipid-based protocols.
We have developed optimized transfection protocols for important viral vector support cell lines including parental and modified Vero (measles and VSV vector) and HEK293 (AAV, adenoviral and lentiviral vector) cell lines. Research production runs can range from small scale vector generation, for instance to support library screening purposes, to large scale production in cell factories or shake flasks to support for instance pivotal in vivo studies. Upon harvesting of vector material, or passaging in case packing cell lines are used, vectors are purified using research protocols, typically involving centrifugation-based methods. Buffers and protocols for formulation and storage of those vectors are available. All research materials are delivered with a certificate of analysis listing characteristics such as yield, purity, integrity and identity. Certificates of analyses can further include mycoplasma and sterility testing results in case materials are to be used for in vivo studies. Owing to the vast experience of our R&D team, the company is primed to deliver high quality research materials in support of pre-clinical studies.
For small scale productions, we offer our SCOUT® technology. This platform enables rapid process optimization by integrating scaled down, high-throughput cell culture systems with high-throughput purification and analytical capabilities.
For large scale productions, we offer MaxCyte cell transfection technology in combination with either our in-house animal component-free medium, or customer-developed medium, using either batch, fed-batch, perfusion or customer-developed processes.
The different upstream scales are matched with appropriately scaled downstream equipment for clarification, chromatography and filtration. For the purification of viral vectors, we offer (but are not limited to) clarification by depth filtration with a variety of different filters including filters that combine particle purification and impurity removal. For analysis of the product, we offer a variety of product specific assays and assay development services, such as TCID50, plaque and neutralization assays, ELISA, (q)PCR and various chromatography methods.
Our broad experience with viral vector 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 etc., allows us to deliver a complete package of purified viral vector, together with associated biochemical and analytical characterization data. We have delivered many viral vector research batches using multiple vector types, including AAV vectors, adenoviral vectors, lentiviral vector, measles vectors and VSV vectors.