High-throughput process & analytical platforms to accelerate gene therapy scale-up
Apr
25
2023
On demand

High-throughput process & analytical platforms to accelerate gene therapy scale-up

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
High-throughput process & analytical platforms to accelerate gene therapy scale-up

For revolutionary gene therapies to reach their full therapeutic potential, high throughput process development workflows are needed to keep pace with the ever-changing landscape of capsids and payloads. In addition, many of the current analytical testing methods are either not able to match the pace of process development, use too much material, or are inherently unsuited to support various unit-operations. As a result, they become a bottleneck to these essential therapies reaching the clinic in a timely manner.

The development of robust fit-for-purpose analytical platforms must match the pace of innovation the industry is seeing. While we continue to discover the broad applications of the various AAV serotypes, their distinct biological properties require tailored, stage-appropriate analytical methods. These methods must be able to provide higher resolution, while also using less material or providing novel insights to keep pace with the ever-increasing speed of process development activities.

  • How serotype agnostic analytics for AAV manufacturing will help reduce testing costs
  • Why current methods to scale-up to larger bioreactors are not sustainable due to cost, transfection efficiency and physical properties
  • Why using an advanced platform with a reduced number of plasmids may increase vector titer by 1-2 logs, resulting in a significantly lower cost of goods sold (COGS)
  • How Resilience & Lacerta are solving for the current challenges and innovating to meet patient demand & reduce overall COGS
Patrick Starremans PhD
Patrick Starremans PhD
Director, Analytical Development, Gene Therapy Franchise, Resilience

Patrick Starremans, PhD is Director of Analytical Development and head of Resilience’s Gene-therapy AD-group. Dr. Starremans received his PhD in Medical Sciences and master's in medical biology from the Radboud University in Nijmegen, the Netherlands and an undergraduate degree in Biochemistry from Zuyd University of Applied Sciences. Following his move to the US, his career has focused on molecular, biochemical and cell-based assay development for the past 20 years, starting in discovery at Harvard Medical School followed by tenures in in-vitro pharmacology at Genzyme, Sanofi, Evotec and Mitobridge finally evolving to Gene Therapy Analytical Development when he joined Voyager Therapeutics building their Process Analytics Group and later as head of Analytical Development building out their CMC-Analytical capabilities and infrastructure and helping Voyager file their first successful IND for an internal program.

Kenneth Warrington PhD
Kenneth Warrington PhD
Chief Technology Officer, Lacerta Therapeutics

Kenneth Warrington, Ph.D., has decades of broad expertise across the cell and gene therapy product development continuum from discovery through GMP-compliant manufacturing to support IND-enabling pre-clinical and early-stage clinical programs. He has deep knowledge in advanced therapy manufacturing, including live attenuated and virus-like particle vaccines, live challenge viruses, viral vectors, and cell & gene-modified cell therapies. He served on the faculty at the University of Florida, Pediatrics-Division of Cellular & Molecular Therapy, with a research program focused on AAV vector development and production.

Following his transition into industry in 2008, Dr. Warrington has held the lead technical operation and business development roles for global contract testing and manufacturing organizations, including Meridian Life Science, SGS Life Science, and Wuxi Apptec. He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the role of chairman of the scientific advisory board and led gene & cell therapy CMC services at GenScript ProBio. Dr. Warrington is currently Chief Technology Officer at Lacerta Therapeutics. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.

Nithya Jesuraj PhD
Nithya Jesuraj PhD
Sr. Manager, Commercial Development, Gene Therapy, Resilience

Nithya Jesuraj, Ph.D., is a member of the Resilience Commercial Development Team supporting the Gene Therapy Franchise. Dr. Jesuraj received her PhD from Washington University in St. Louis where she designed Schwann-cell based therapies to regenerate peripheral nerves across acellular nerve grafts. Following her graduate work, she spent 8+ years in various Research roles, including leading an R&D team at Bio-Techne. As an R&D leader, Dr. Jesuraj contributed to the successful development and launch of reagents used in immune cell therapy therapies. Dr. Jesuraj pursued a career in Product Management where she managed and helped grow Bio-Techne’s CDMO business prior to joining Resilience.