Best Practices of Downstream Protein Purification and Product Concentration

12th September 2023 | 1:30PM IST / 4:00pm CST / 9:00am BST / 10:00am CEST | Presented by Krishnamurthy Venkatesan, Downstream MSAT Lead, Senior Director at Biocon Biologics |WATCH FOR FREE

Downstream protein purification and product concentration is known to be the most challenging part of the process development. It is also known that the Downstream process development is critical to ensuring protein drug quality, safety & efficacy meet regulatory expectations. When initiating the development, the Chemistry, manufacturing and controls considerations for process development and manufacturing must include molecule complexity. Raw materials, process development. Equipment and manufacturing, Quality and Regulatory Affairs

The critical factors for development and manufacturing is performing a stage-wise assessment on Product development, analytical and process development and not least, the manufacturability assessment. The expected qualities of a superlative process shall include increased capacity, flexibility, cost-effectiveness, controllability, scalability, and efficiency

However, general challenges exist in downstream process development involving,

  • Balancing higher cost chromatography resins and solvents
  • Constrained purification space for molecules prone to degradation at a wide range of pH and temperature
  • Process fit to multi-product facility,
  • PAT availability to accelerated processing
  • Adaptation of new technologies is one of a smarter way to address the challenges:
  • Non-Protein A process
  • use of next-generation chromatography resins
  • Continuous processing for capture, intermediate purification, Viral clearance

Presented by Krishnamurthy Venkatesan, Downstream MSAT Lead, Senior Director at Biocon Biologics

Krishnamurthy Venkatesan is a Biopharma professional with protein purification expertise gained through 20 years of experience in a wide range of responsibilities. He earned his degree in Chemical Engineering followed by a master’s in biotechnology from Anna University. He is currently the Lead, Manufacturing science and technology for Downstream at Biocon Biologics, Malaysia. Krishnamurthy started his career as a Downstream process development scientist involving chromatography, enzyme-based reaction, crystallisation for proteins and peptides as biotherapeutics, and further on, expanding knowledge towards technology transfer, manufacturing support and CMC.
During the path, he gained an understanding of the Quality by design (QbD) approach identifying critical quality attributes and Critical process parameters, process design space and In-process controls, utilising assessment-based scale-up methodology and mitigation plan. Later, this enabled him to lead a team of scientists from early to late-stage process development, pilot scale studies towards scale-up, technology transfer, and process improvements. He was involved in multiple pre-approval and periodic inspections by FDA, EMA and other agencies leading to successful approval of Biosimilars developed and scaled-up to manufacturing and gained thorough knowledge on technology transfer to large scale manufacturing and continuous process improvement through process excellence including effective Dossier and comparability package for Agency approvals of multiple biosimilars.

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