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 are known to be the most challenging parts of process development. It is also known that downstream process development is critical to ensuring protein drug quality, safety, and efficacy meet regulatory expectations. When initiating the development, the chemistry, manufacturing, and control 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 are performing a stage-wise assessment of 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 smarter way to address the challenges:
Non-Protein A process
use of next-generation chromatography resins
Continuous processing for capture, intermediate purification, and viral clearance

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

Krishnamurthy Venkatesan, Downstream MSAT Lead, Senior Director at Biocon Biologics presents a webinar on the Best Practices of Downstream Protein Purification and Product Concentration — Krishnamurthy Venkatesan is a Biopharma professional with protein purification expertise gained through 20 years of experience in a wide range of responsibilities. He graduated from Anna University with a degree in chemical engineering and then went on to earn a master’s in biotechnology. He is currently the lead for manufacturing science and technology for downstream at Biocon Biologics, Malaysia. Krishnamurthy started his career as a downstream process development scientist involving chromatography, enzyme-based reactions, 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, in-process controls, utilising assessment-based scale-up methodology, and developing a 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-approvals and periodic inspections by the FDA, EMA, and other agencies, leading to the 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 an effective dossier and comparability package for agency approvals of multiple biosimilars.

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