A systemic technology transfer tool to achieve manufacturing process milestones
Current challenges in technology transfer for both CDMO (Contract Development and Manufacturing Organization) and sponsors are timely completion of milestones within approved budget. 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 have achieved fifteen successful technology transfers in the last two and 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 risk mitigation plan to ensure First Time Right
• Decision Flow chart for technology transfer evaluation
• Confidence level assessment using decision tree
• 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)
This presentation will give the audience a good understanding on (i) key questions to enable decision for way-forward; (ii) risk analysis and mitigation strategies; (iii) parameter selection and evaluation for technology transfer.
Jogi Amit is a General Manager at Syngene International Ltd and Leads 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 since the last 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 phase 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 in multiple publications, a speaker in international conferences and a book co-author.
Key Learning Objectives
- Significance of technology transfer
- Devising a systemic approach to achieve 100% First Time Right
- Process fitment parameters to ensure successful technology transfer
- Case studies – methodology for successful implementation of systemic technology transfer approaches
- Principle / Lead Scientist
- Assistant / Deputy / Senior General Manager
- Senior / Associate Director
- Principle / Lead Investigator
- Process Engineers
- Head of Research & Development
- Head of Technology Transfer
- Head Technical Operations
- Director – Pharmaceutical Development Biologics
- Chief Scientific Officer
- Head – Biologics Drug Product Development & Manufacturing