Technology Transfer: A Systemic Approach to Achieve Manufacturing Process Milestones

The current main challenge in technology transfer for both CDMO (Contract Development and Manufacturing Organization) and sponsors is the timely completion of milestones within their approved budgets. Working effectively with limited small-scale data is more critical for a biopharmaceutical CDMO, as it directly impacts the project cost and timeline, in turn influencing the collaboration with the client.

An efficient and successful technology transfer to manufacturing plant is the outcome of a systemic approach to scale up. The systemic approach depends critically on understanding of engineering parameters as well as the team’s scientific and practical knowledge. Challenges during scale up can be attributed to technical knowledge, infrastructure and equipment constraints.

At Syngene, we have successfully devised a systemic approach demonstrating ‘first-time right’ technology transfer processes to our GMP manufacturing plant. This approach, when applied to scale-up projects, ensures timely achieving of clinical and commercial milestones, and compressed time-to-market expectations. It also helps in speeding up last mile delivery (products to patients). So far, Syngene has achieved fifteen successful technology transfers in the last two and a half years, without any failure or major technical glitches.

Our ‘first-time right’ technology transfer approach has resulted in significant reduction in cost by avoiding multiple engineering/technical batches and meeting important project milestones.

This presentation will cover:

• Approach design, evaluation criteria and a risk mitigation plan to ensure ‘first time right’
• A decision flow chart for technology transfer evaluation
• Confidence level assessments using decision trees
• Case studies which demonstrate Syngene’s experience in achieving 100% ‘first time right’
• Case studies on technology transfer of upstream and downstream processes (monoclonal antibody production process)

Speaker

Amit Jogi, Sr. General Manager, Syngene International Limited

Amit Jogi is a Sr. General Manager at Syngene International Ltd and Lead of Biologics Manufacturing Operation. He has over ~20 years of experience in Contract Research and Manufacturing of Biopharmaceutical products, Upstream Development, Manufacturing Science and Technology (MSAT), and Manufacturing Operations.

He has been with Syngene for 11 years. He led the manufacturing operations to obtain European Union GMP certification for Syngene. He has experience with more than 25 molecules (proteins and mAbs) in development programs and more than 20 molecules in manufacturing for different phases of clinical supply. Prior to Syngene, he has worked at Magene Life Sciences, Claris Life Sciences and Cadila Healthcare ltd. Amit is a Bioprocess technologist by training and has a Ph.D. in Microbiology. He is also an author of multiple publications, a speaker in international conferences and a book co-author.

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