De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing for Gene Therapy Applications



11th July 2024 | 2:00pm IST / 4:30pm CST / 9:30am BST / 10:30pm CEST / 3:30am EST / 12:30am PST | Presented by Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma |BOOK FREE SEAT FOR THIS WEBINAR

The rush to develop an affordable and accessible COVID-19 vaccine not only accelerated research and development of therapeutic modalities like viral vector, mRNA and pDNA based vaccines but also challenged the bioprocess community to solve for unique scale-up related challenges to manufacture these important life-saving medicines.

Adenoviral vectors are attractive vectors for delivering genes for other gene therapy applications. These vectors can accommodate large transgenes, transduce quiescent and dividing cells, and do not integrate into the host’s genome. Adenoviral vector technology using HEK293 host cells has been around for a long time and the manufacturing process includes upstream processing (HEK293 cell culture and viral infection), followed by series of clarification, filtration, and chromatography steps to produce drug substance with high purity. Although, the process unit operations seem uncomplicated, manufacturing at large scale in single use systems has remained a major challenge due to poor and inconsistent cell growth in suspension culture during scale-up, low viral titers, product aggregation, inefficient separation of empty and filled viral capsids, as well as complexities related to handling large volume viral infection. Hence, there is a strong requirement to build robustness and scalability in early process development to minimize unnecessary late-stage process changes, as well as design cGMP facility and strong quality culture to handle operational complexities and reduce risks associated with viral vector manufacturing.  

The webinar will illustrate key questions and challenges in large -scale manufacturing of viral vectors from a process robustness, facility design and product quality standpoint as well as our experiences in debottlenecking these challenges to scale adenoviral vector technology at 2000L and beyond.     

Presented by Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma

Prateek Gupta, PhD Senior Vice President, Process Development & MSAT at Stelis Biopharma presents a webinar on the De-bottlenecking Challenges in Large Scale Viral Vector Manufacturing for Gene Therapy Applications

Prateek is currently serving as Senior Vice President of Technical Development & MSAT at Stelis Biopharma, an integrated biopharmaceutical CDMO based out of India. In this role, he provides overall leadership for delivering high-value biopharmaceutical technical development services for global customers and is responsible for building strategic growth plans and capabilities to maintain a robust project pipeline. Prateek is passionate about developing and manufacturing high quality affordable biologics and vaccines and contributing to improved access to patients worldwide. Prateek has over 15 years of experience, including international leadership roles in global biopharmaceutical companies and academic institutions, in product development and manufacturing of novel biologics and biosimilars. Prior to Stelis, Prateek was Senior General Manager and Head of Process Science, R&D at Intas Pharmaceuticals, where he was responsible for technical and operational strategy for the development of cell lines and cGMP-ready processes for company’s biosimilar portfolio. Prateek previously served in increasingly responsible roles in Pfizer, Total Energies and started his career at Genentech-Roche. Prateek has exceptional academic pedigree with a PhD in Chemical Engineering from Cornell University (USA) and Bachelors from Indian Institute of Technology (IIT), Delhi. He has authored numerous publications and has been the recipient of prestigious W.H. Peterson award for best research presentation at the American Chemical Society.


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