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
    Screening of basal media, supplemented media, and media additives to formulate brand new media are all completed to enhance cell culture performance.
  • Batch and fed-batch process design, characterization, and optimization
    Process design, characterization, and optimization is developed on a unique project basis—every process is uniquely designed and developed to address its short, medium, and long-term requirements, keeping development efficiency in mind. The nature of the molecule, its target, its required quantities, other parameters that could influence process conditions are all taken into account as the Experimental strategy for the process development is outlined.
  • Metabolite screening
    One of the key optimization parameters to understand the dynamics of the process, allowing for rapid understanding and enhancement of process conditions by analyzing culture metabolic rates and metabolites.
  • Bioprocess profile mapping
    Every bioprocess has a lifecycle profile that is unique to it. An initial up-front profile mapping is essential for the in-depth understanding of the particulars of each stage of its lifecycle. This allows for the increase of productivity efficiency at each day relative to the culture’s lifecycle and # of viable cells in culture. This is what allows for the fine-tuning of the process optimization stage of development, increasing productivity yields up to <5g/L.

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