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.

 

I have worked with Dave over the last 10 years on a number of different wide ranging projects, in both Europe and the US, from early stage to end product for Phase III clinical trials. I have always found him to be extremely knowledgeable, helpful and resourceful. He has been an asset, ready to provide helpful suggestions, find solutions drawing from his vast experience and connections and tackle any problems that arise during the course of development of drug product. It has been a pleasure working with him.

Dr. Laura Rosa Brunet, CSO Immodulon Therapeutics Ltd and Consultant at RB Consulting Ltd