Midstream unit operations: Unsung heroes in AAV process development

Gene therapy aims to provide cures for life-threatening diseases that currently rely on complex and expensive life-long medications presenting a significant opportunity for companies to help people to live better lives. Although the quest for a templated process to speed up in the race to commercialization has largely remained elusive, we are starting to see evidence of scientific data from the process development experts. 

Midstream unit operations consist of steps such as cell lysis, DNA digestion and clarification. These are considered gold-standard unit operations in Adeno Associated Virus (AAV) production processes. Optimization of this midstream set of unit operations use should a mandatory step in process development. Collaborations between technology providers and gene therapy companies are critical in establishing know-how and solving the toughest challenges in gene therapy manufacturing. An example of a fruitful partnership between Merck and Precision BioSciences in developing an integrated approach to an AAV harvest step will be presented in this webinar.

• Discover critical success factors for midstream AAV bioprocess steps including cell lysis, DNA digestion and clarification.
• Case studies from Precision BioSciences
• DoE (design of experiment) approaches and data driven insights
• Scale-up considerations for a commercial manufacturing process

Matthew Roach

AAV Process Development Team Leader, Precision BioSciences

Matt leads the AAV Process Development group at Precision BioSciences, which is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his Bachelor's degree in Biological Sciences at North Carolina State University and his Master's degree in Microbiology and Cell Science at the University of Florida. Prior to Precision, Matt spent time at Pfizer working on the purification of AAV and the Biomanufacturing Training and Education Center training industry professionals on downstream bioprocessing operations.

Ratish Krishnan

Senior Strategy Consultant, Novel Modalities BioProcessing Group, Merck

Ratish Krishnan is a Senior Strategy Consultant in the Novel Modalities BioProcessing group for the Americas at MilliporeSigma. He is passionate about providing solutions to bring treatments to market. A Process Development Scientist by background, he has over 13 years of experience in vaccine, monoclonal antibodies and viral vector modalities from pre-clinical to late stage process characterization, validation and commercialization activities such as BLA authoring. As a Biochemical engineer, he holds a Master’s degree in biotechnology from the Pennsylvania State University. Ratish has managed process development teams at Novartis and Pfizer prior to his current role where he serves as global subject matter expert for viral vector manufacturing and provides strategic guidance to internal stakeholders and key customers. He is active in his thought leadership activities at scientific conferences, technical webinars and key authorship contributions in peer-reviewed articles and white papers.

Watch now

SPEAKERS

Matthew Roach

AAV Process Development Team Leader, Precision BioSciences

Ratish Krishnan

Senior Strategy Consultant, Novel Modalities BioProcessing Group, Merck

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