Biologics Development Strategies

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Biologics Development Strategies

Bioprocessing engineering is a critical part of biotechnology which is widely used to produce clinically important, high-value therapeutics such as monoclonal antibodies, recombinant proteins, viruses, plasmid DNA and vaccines in large scale quantities

The bioprocessing community is constantly in need of new technologies to address challenges in GMP compliant, large-scale production from and range of bioreactor formats and varied downstream unit operations.

Within Bioprocessing, there are a number of challenges linked to the robust, reproducible, scalable and cost effective production of each therapeutic class. In addition, through the applications of the core principles the industry continues to strive develop cost effective medicines by streamlining production methodologies whilst maintaining/improving the product profile and importantly, the patient safety profile of these key biotherapeutic classes. In particular, the need for scalable cost-effective manufacturing is a key requirement for the field.

Commercially relevant bioprocesses will:

  • Robustly and reproducibly produce biological products that maintain all of the key product quality attributes
    • Including optimisation of critical process control parameters to maintain product quality attributes using DoE and QbD approaches
  • Seamlessly supply both pre-clinical, clinical and commercial quantities of biotherapeutics
    • The processes and production technologies must be readily scalable and be capable of being validated
  • Control CoGs of the final drug product. This aspect is critical to building the foundation for a commercially viable industry.