Media and Process Development
To maximize performance of cell lines, biopharma manufacturers must find the right media and feed strategy based on empirical data from media screening and optimization, as well as nutrient testing. Feed volumes and timing of feed administration should be determined for each specific process and cell line via high throughput (HTP) and design of experiment (DOE) approaches. These can be conducted internally or by partnering with experts to expedite simultaneous screenings.
Ensuring Lot-to-Lot Consistency of Raw Materials
Lack of consistency in raw materials can create significant variation in upstream processes, causing unexpected loss of cell density and viability – and ultimately, reduced yield. A better understanding of raw materials increases ability to control process variabilities. This can be achieved by tracing the supply chain back to raw materials and characterizing them.
Related Product Resources
Raw Material Selection
Webinar: Bioprocessing Raw Materials: Risk Mitigation Strategies
Webinar: The Importance of Media Selection and Scale-down Models for High-titer Expression in CHO Cells
Raw Material Evaluation and Characterization
Expediting Raw Material Qualification
Current regulatory and industry guidelines do not define clear standards for chemicals used in upstream bioprocessing. In the absence of standards, drug manufacturers rely heavily on their suppliers for efficient sourcing and qualification of raw materials; however, typical timelines to collect raw material information via questionnaires and separate statements can be unacceptably long, often taking several weeks. Consequently, manufacturers are seeking supply partners who can provide raw materials that are stringently qualified to industry-leading standards and are supported by comprehensive documentation packages that meet pharmaceutical manufacturers’ information needs when qualifying raw materials, completing a risk assessment or optimizing a manufacturing process.
Overcoming insoluble or Unstable Amino Acids
The essential amino acids tyrosine and cysteine present a challenge when used in upstream processing, due to low solubility (tyrosine) and low stability (cysteine) at neutral pH. To simplify fed-batch processes and enable high available concentrations of both amino acids, chemically-modified tyrosine and cysteine enable a single feed strategy at neutral pH. Other benefits of this approach include reduction of feed volume and increased volumetric productivity.
Workflow
Cell Line Development
Development begins by selecting single-cell clones that can produce the biologic of interest, then screening for clones that are stable, productive, and scalable
Bioreactor Production
Choosing an upstream platform must take many considerations into account, including scalability and quality control of the bioreactors and mixers
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
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