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)
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.Message Presenter
Who Should Attend?
- Biopharmaceutical Companies
- Companies in the Biologics Development Field
What You Will Learn
This presentation will give the audience a good understanding of key questions to enable decision for way-forward, risk analysis and mitigation strategies, parameter selection and evaluation for technology transfer.
- Learning Objective 1: Significance of technology transfer
- Learning Objective 2: Devising a systemic approach to achieve 100% ‘first time right’
- Learning Objective 3: Process fitment parameters to ensure successful technology transfer
- Learning Objective 4: Case studies – methodology for successful implementation of systemic technology transfer approaches
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022) is an integrated contract research, development and manufacturing services company serving the global pharma, biotech, nutrition, animal health, consumer goods and specialty chemical sectors.
Our 4200 scientists have both the skills and the capability to deliver great science, ensure robust data management, IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
With 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene offers dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife. We also work with biotech companies pursuing leading edge science, and MNCs including GSK and Merck KGaA.