Prakash Balasubramanian

WORKED PROJECTS

• Successfully produced a biosimilar, recombinant streptokinase, utilizing recombinant E. Coli through optimized fermentation technology, ensuring high yield, purity, and compliance with regulatory standards.
• Conducted the upstream production of Liraglutide drug substance utilizing recombinant E. Coli, optimizing the fermentation process.
• Successfully used recombinant E. Coli and fermentation technology are used to manufacture Recombinant enterokinase enzyme.
• I handled the Insulin Glargine drug substance's scale-up project, streamlining production procedures, and guaranteeing a smooth transition from lab to commercial manufacturing.
• Contributed to the research and development of Semaglutide drug substance production, with a focus on process optimization to achieve superior yield, quality, and regulatory compliance.

KEY RESPONSIBILITIES

• Helped with pre-processing tasks, like seed preparation, sterilization, and media preparation for the batch process.
• Managed fermentation processes for the production of biologics, ensuring optimal growth conditions, and high-yield production.
• Monitored and analyzed fermentation performance through real-time data collection, and troubleshooting deviations to ensure process efficiency.
• Performing purification procedures like filtration, homogenization, and centrifugation.
• Developed precise and detailed BMRs and SOPs in cooperation with cross-functional teams, guaranteeing operational effectiveness, and regulatory compliance.
• Documented manufacturing processes in BMRs with precision, and in compliance with cGMP guidelines, to ensure product quality and traceability.
• Coordinated the timely review and approval of BMRs to maintain constant manufacturing cycles in a cGMP-regulated environment.