Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development and manufacturing scale-up

• Discuss how to accelerate the clone selection by using the mini bioreactor systems
• A case study on the use of mini bioreactor for high producer and good quality clone selection
• Understand how to implement the bioreactor systems effectively with minimal resources

• Study of scale-up approaches and basis of process scale-up selection criteria ( A case study)
• Consideration of CPP and KPP for a successful process and scale-up study
• Role of PAT, DoE and AI in process optimization and economical bio-production
• Know how to scale-down model definitions suitable for design space, QbD, or other BLA-enabling activities.

Sanjeev Gupta, Ph.D., Vice President and Head Advanced Biotech (Biosimilar Division), Ipca Laboratories Ltd., Mumbai-India

Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Vice President and Head, Advanced Biotech Lab (Biosimilar Division), Ipca Laboratories Ltd., Mumbai, India. Dr. Gupta carries around 22 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies. His core expertise lies in Molecular Biology, Cell Line, Upstream process development, Bio-analytical, Regulatory as well as Tech Transfer to the GMP for Clinical and Commercial manufacturing. Till date, he developed and contributed for over fourteen recombinant molecules, of which eight biosimilars are already launched in the Indian market and the rest are in the developmental or clinical phase, and are expected to be launched in near future. He delivered talks on Biosimilars at various national and international conferences organized by IBC, Terrapin, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM. He has published several Research articles (12), Book chapters (06), Magazines (06) and patents (01) in lieu of Biosimilar development.  During his professional tenure, he worked at various position in reputed Indian biopharmaceuticals industries such as Zydus-Ahmedabad, Wockhardt-Aurangabad, Panacea-New Delhi, Intas-Ahmedabad and  at present with Ipca Laboratories, Mumbai.

Vaibhav Patil Manager of Data Science, APAC at Sartorius Data Analytics

Vaibhav Patil is a Manager of Data Science, APAC at Sartorius Data Analytics. He is master of Bioprocess Technology with ~16 yrs. of industrial exp. with a multidisciplinary role in Process R&D, Manufacturing, and Data analytics spanning across Pharma, Chemical, and FMCG sectors. He has gradually moved from R&D heavy role to DoE/QbD/PAT and data analytics, pre-sales, ROI, and technical role. He have experience working as an individual contributor as well as a managing team. He have extensive hands-on exposure to various ML/AI algorithms, Mechanistic / Hybrid Models, Data visualization, and data wrangling platforms along with in-depth functional knowledge about the process/manufacturing industry. Before joining Sartorius Data Analytics in 2018, he was a Manager of Statistics at Pfizer. Prior experiences include Associate Investigator at DuPont and Jr Scientist at Dr. Reddy’s Lab. His major focus areas are applying advanced data analytics tools for pharma applications, data-driven decision making, process monitoring, predictive analytics, Continuous improvement, and QbD/PAT.

Deepak Vengovan, Manager of Field application at Sartorius

Deepak Vengovan has 14 years of experience in the bio-pharmaceutical industry both as an end-user and as a solution provider. He holds a Master’s degree in Biotechnology. Deepak started off his career in 2009 as a Process Development Scientist within the Research & Development team in Biocon research center, India. Over a period of five years, he was actively involved in the mAb process development, tech-transfer, validation & testing new technologies like intensification on pre-established mAb process. He joined Sartorius in 2013 as a Media Specialist supporting biosimilar customers on media development, optimization, Customization and scale up, since 2017 he has been leading the upstream team in India supporting different single use and multiuse upstream projects. In his current role Deepak is responsible as a Manager of Field application team taking care of the south region for Sartorius Stedim India Pvt. Ltd..

Sponsored by Sartorius

We deliver and implement rapid and cost-effective Biomanufacturing solutions from early phase development through scale-up to commercial manufacturing. Benefit from the most comprehensive bioprocess technology portfolio coupled with our expertise in Single-use bioprocess engineering. Our global bioprocess teams are available to discuss your process development and manufacturing requirements.