Beyond cell line engineering and clonal selection, ProteoCell integrates the latest Bioprocess advances into the Upstream (Cell Culture and Fermentation) and Downstream components of its ProteoCell SSI platform—which in addition to its cell lines, arrive at baseline bioprocesses yielding MoAb material on the order of 3-5g/L.
Upstream
Upstream PD at ProteoCell Biotechnologies begins in small flask cultures and continues in shaker and larger spinner flasks until bioreactor scale. A unique feature of Upstream PD at ProteoCell is its overlapping with clonal selection process from Cell Line Engineering. This allows for a higher level of stringency and efficacy in the clonal selection process having screened the clones for initial performance in a production batch setting.
Batch, Fed-Batch, and Perfusion Cell culture development employ extensive screening and analyses in an industry-leading process pace to arrive at the optimal Upstream Bioprocess required. Additionally, scalability is considered from the bench-top to the Pilot Plant to ensure continuity and replicability of the process in scale-up mode. Depending on process requirements, practical and pragmatic scalability is a key driving force in Process Development at ProteoCell Biotechnologies. Key PD components are:
- Media formulation and optimization
- Batch and fed-batch process design, characterization, and optimization
- Metabolite screening
- Bioprocess profile mapping
Downstream
ProteoCell depends on a wealth of expertise, whether in-house, or through an established commercial process solutions vendor partner for the latest in DSP solutions. Be it chromatography, viral reduction/clearance, or filtration, ProteoCell develops robust DSP processes to retain as high a percentage of the Bulk material cultured as possible. Areas of concentration include
- Chromatography
- TFF, UF/DF
- Viral Clearance/inactivation
- Folding/Refolding steps