Batavia Bioservices offers capabilities for the development of scalable, pharmaceutical grade mammalian cell lines and cell culture processes for the production of all major classes of biopharmaceuticals including recombinant proteins, classical and vector based vaccines, monoclonal antibodies and gene therapy products.
Services offered include cell culture process development, purification development, assay development. product characterization and process transfer. Click on each service for a detail description:
- Cell culture process development (mammalian & microbial)
- Purification development
- Assay Development
- Product Characterization
- Process Transfer
Cell culture process development (mammalian & microbial)
Mammalian platforms
Services offered include optimization of cell growth and production conditions, medium and feed development, optimization of harvest time (for yield and product quality), pre-culture development and scale up from 2 ml to 200L scale. Analytical support for these activities includes metabolic analysis (NOVA Flex) and medium component analysis (eg: amino acid analysis by HPLC).
A novel high throughput, small scale spin tube cell culture system, which allows many hundreds of experiments to be performed in parallel, enables rapid process development such as parameter optimization, medium screening and development, cell line selection etc to be performed. Data generated using this technology is predictive and scalable through shaken square bottles and shake flasks to bioreactors at 200L scale. Final processes are delivered together with all appropriate documentation needed for direct transfer to a GMP manufacturing facility for clinical lot production.
The company owns cell banks for CHO-S,CHO-K1, HEK293, VERO, MDCK and our staff have hands –on expertise with many other mammalian cell lines.
Microbial Platforms
Services offered include fermentation of E. Coli and L. Lactis, medium optimization for growth and production phase, selection of critical process parameters, development of scalable control strategy for pH and oxygen supply and plasmid production.
A series of bioreactors is available from 0.5L up to 20L for small scale production, scalability analysis and development of control strategies. The development activities can be supported by medium component analysis (eg: amino acid analysis by HPLC) and product characterization by our analytical group.
Purification development
Batavia Bioservices offers capabilities for the development of pharmaceutical grade, scalable purification processes for all major classes of biopharmaceuticals including recombinant proteins, classical and vector based vaccines, monoclonal antibodies and gene therapy products. Services offered include small scale, high throughput technologies such as 96-well formats for resin, filter and condition screening and scouting experiments, spin trap and small column systems for second phase screening, Akta Explorer and bench scale filtration systems for development of chromatography and filtration based process steps and Akta Pilot based systems for large scale operation. Final processes are delivered together with all appropriate documentation needed for direct transfer to a GMP manufacturing facility for clinical lot production.
Assay Development
Batavia Bioservices offers capabilities for the development and qualification of biochemical and analytical assays needed for the analysis and characterization of all major classes of biopharmaceuticals. Assays for identity and integrity (for example SDS-PAGE (Reduced / non-reduced), Isoelectric focusing (IEF) and Western Blot Analysis, concentration (for example ELISA, RP-HPLC), aggregation (for example HP-SEC), glycan profiling (HPLC based), Potency (various cell based in-vitro assays) and residuals (for example Q-PCR for host cell DNA etc) are offered. Assays are delivered together with a full report and all documentation needed for direct transfer to a GMP manufacturing facility for clinical lot release testing and/or stability indicating assays.
Product Characterization
A key deliverable for any biopharmaceutical production process is that it should deliver consistently high quality material. Furthermore, in line with the concept of Quality-By-Design and the role of the design space in the development of modern biopharmaceutical production processes (basically a range of process parameters within which the critical product quality attributes do not change), Batavia Bioservices closely integrates its cell culture, purification and assay development activities and technologies.
For example, the development of a simple, small scale purification protocol early in the development process that can deliver material of suitable quality and purity for analysis can be useful to generate small quantities of product for early product characterization. Similarly, the high throughput cell culture spin tube system can be utilized in connection with high throughput purification technologies to generate small quantities of partially purified material from a cell line generation program such that functional data (eg: in-vitro activity) or quality data (aggregation, charge etc) can be used in the final selection.
Process Transfer
Batavia Bioservices develops cell culture and purification processes, lot release and stability indicating assays and mammalian production cell lines that are delivered with all the documentation and batch records that enable transfer of the process to a GMP manufacturing facility for clinical lot production. On top of this our staff is experienced with Clinical Manufacturing. Batavia Bioservices possesses its own GMP facilities. For more details see our page on Clinical Manufacturing.
In case a products does not fit the Batavia Bioservices GMP facilities, our staff is experienced with process transfer and can aid with the selection of suitable external GMP manufacturers.
