Your research is only valuable if your data can be reproduced. Crucial therefore, is the use of high quality, well characterized research materials for your pre-clinical studies. Our capabilities and experience allow us to be your research partner and deliver microgram to gram quantities of proteins and antibodies, diverse vaccine formats and gene therapy vectors.
Batavia Biosciences has successfully used its mammalian and microbial expression platforms for delivering a broad range of diverse research reagents. Our manufacturing capabilities have allowed us to deliver, among others, vaccines (attenuated, split, subunit, VLP, whole-inactivated), diverse viral vectors (AAV, adenovirus, lentivirus, measles, and VSV), Fab, F(ab’)2, and scFv antibody fragments, full lengths antibodies, toxic proteins and highly glycosylated proteins.
For both our microbial and mammalian production platforms, we deploy a wide variety of cell culture formats. For example, our mammalian capabilities include adherent, microcarrier and suspension culture. We can deploy a variety of mammalian cell lines, including CHO, HEK293, VERO, MDCK and MRC5, or use our engineered E.coli strains. Production scales can range anywhere from small (2-20 mL) to intermediate (0.5-200 L).
From a wide variety of equipment, we can select the most suited to produce your molecule of interest. For suspension cultures it could be shake flasks, roller bottles, WAVE BioreactorTM systems or stirred tank bioreactors. For adherent cell cultures it could be cell factories, iCellis® system or NevoLineTM system. For very small scale productions (microgram to milligram range), we typically apply our SCOUT® technology. This system integrates high throughput cell culture with high throughput purification and matching analytical capabilities. When larger quantities are required, we can deploy our optimized high cell density flow electroporation technology for transient productions up to 100 L scale using our in-house animal component free batch, fed-batch or perfusion protocols. Alternatively, we can use our STEP® technology to develop stable producer cell pools in record time or help you to further develop your manufacturing process and select the optimal growth media.
Matching our upstream capabilities, we can deploy a variety of equipment for clarification, chromatography and filtration. For example, in the purification of proteins and antibodies, we offer clarification by depth and membrane filtration for mammalian cultures and by either filtration or microfiltration for microbial cultures. Prior to purification, concentration and buffer exchange using tangential flow filtration is typically performed using flat screens. Purification is achieved using several chromatography steps. The chromatography methodology used is dependent on the molecule of interest with a variety of properties being exploited via affinity, pseudo affinity, ion-exchange, hydrophobic interaction, size-exclusion or mixed mode to achieve the desired purity. If required, viral clearance filtration can be performed.
Formulation is typically performed using desalting chromatography or buffer exchange using a flat screen tangential flow filtration. Sterile filtration is performed using 0.2 µm or 0.22 µm filters. Finally, for analysis of integrity, purity, yield and identity of research preparations, we use our developed product specific assays like SDS-PAGE, Western Blot, ELISA and various chromatography methods.
Our comprehensive expertise on cell culture, purification, product analysis and characterization allows us to deliver a complete package of purified product together with associated biochemical and analytical characterization data. We have successfully delivered diverse biosimilars proteins, growth factors, fertility hormones, clotting factors, antibodies, antibody fragments, viral proteins and antigens for R&D purposes.
Batavia Biosciences offers high quality vaccines and viral vectors (i.e. adeno, lenti, AAV) for R&D purposes. We have extensive experience culturing various customer specific cell lines, or alternatively offer our own cell banks of HEK293, MDCK and VERO for production. For small scale productions, we offer our SCOUT® technology. This platform enables rapid process optimization through the integration of scaled down high throughput cell culture systems with high throughput purification and analytical capabilities. For large scale productions, we offer MaxCyte technology in combination with either our in-house animal component free batch, fed-batch, perfusion or customer-developed processes or medium.
The different upstream scales are matched with appropriately scaled downstream equipment for clarification, chromatography and filtration. For the purification of viruses and viral vectors we offer (but are not limited to) clarification by depth filtration with a variety of different filters including filters that combine particle removal and impurity removal. Removal of nucleic acids is often required for viral products and may be achieved by techniques such as enzymatic lysis 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 target virus’ physical properties and the requirements of the final product. Purification is normally achieved using several chromatography steps. The chromatography used is dependent on the viral properties. Commonly for purification, ion-exchange or hydrophobic interaction differences are exploited. While 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, where this is not feasible, we have extensive experience in aseptic validated manufacturing processes. For analysis of the product, we offer a variety of product specific assays and assay development services, like TCID50, plaque and neutralization assays, ELISA, (q)PCR and various chromatography methods.
Our vast experience with virus and 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 like yield, purity, integrity, infectious vs empty particles etc., allows us to deliver a complete package of purified vaccine or vector, together with associated biochemical and analytical characterization data.
We have successfully delivered diverse vaccines for preclinical studies, including but not limited to influenza, Sabin polio, Salk polio, RSV, rhinovirus and hepatitis A. In addition, we have delivered many viral vector research batches using multiple vector types, including Adenoviral vectors, AAV vectors, Lentiviral vector, VSV, CMV, MVA and Measles vectors.