Expert roundtable: Exploring current and future trends in lentiviral vector manufacturing
Sep
27
2023
On demand

Expert roundtable: Exploring current and future trends in lentiviral vector manufacturing

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Expert roundtable: Exploring current and future trends in lentiviral vector manufacturing

To date, several potentially curative lentiviral vector (LVV) based cell and gene therapies have been approved by the US FDA, and many more are in clinical trials. LVV play a crucial role in delivering transgenes into immune cells to correct genetic defects.

LVV design involves selecting a suitable backbone, promoter, and enhancer sequences to drive gene expression in the targeted cells. To successfully package such vectors, transgene of interest, regulatory elements and packaging signal are all essential components.

The LVV manufacturing process involves multiple steps including plasmid construction, transfection of packaging cells, vector production, purification, and quality control. During this process, many challenges (e.g., scalability, purification, quality control, GMP compliance, genetic stability) need to be carefully addressed to unlock the full potential of LVV-based cell and gene therapies. As advancements continue, overcoming these challenges will pave the way for broader clinical applications and improved patient outcomes.

This Roundtable discussion will draw together several acknowledged experts from the fields of LVV design, manufacture, and regulation to examine the key current trends in the space, and point the way to future success.

  • Reviewing the current status of the LVV-based cell and gene therapy field
  • Uncovering the role of plasmid DNA as a starting material
  • Addressing challenges in LVV manufacturing
  • Overcoming QC and regulatory hurdles
Aaron Vernon
Aaron Vernon
Chief Manufacturing Officer at Quell Therapeutics

Aaron serves as our Chief Manufacturing Officer, having joined in 2023. He joins from TCR2 Therapeutics where he served as the VP, Manufacturing with responsibility for Manufacturing, Supply Chain, MSAT, and Patient Operations. Prior to that, Aaron was Vice President, Engineering & Supply Chain at Autolus, Inc., where he led the build out of their Global Supply Chain function, build of their Manufacturing network, and managed their internal Manufacturing at CGT Catapult in Stevenage, UK – and was VP, Global Supply Chain & Manufacturing at Sucampo Pharmaceuticals, where he was responsible for global supply of all commercial and clinical products.

Aaron has over 20 years of experience within manufacturing, supply chain, business process development, organizational transformation, and facility design/construction at Johnson & Johnson, MedImmune, AstraZeneca, Sucampo, Autolus, TCR2 Therapeutics, and now Quell.

He holds a B.S. in Mechanical Engineering from the University of Pennsylvania, an M.S. in Mechanical Engineering from Rutgers, and an M.B.A. from University of Maryland – Global Campus.

Palani Palaniappan
Palani Palaniappan
Chief Technology Officer at Flagship Pioneering

Palani joined Flagship Pioneering in 2021 and is Chief Technology Officer of Pioneering Medicines. In this role, he leads the strategy and implementation of chemistry, manufacturing and controls (CMC) aspects of asset development, ensuring Pioneering Medicines establishes a world-class and cutting-edge technical operations function. Palani received his Ph.D. from the Indian Institute of Technology, Kanpur and completed his post-doctoral studies in biochemistry and biophysics at the University of California, Riverside and Virginia Commonwealth University. He holds a M.S. and B.S. from Annamalai University. He has completed executive leadership education at Oxford University and at Insead. From 2017 to 2020, Palani served on the Board of the International Consortium for Innovation & Quality (IQ), and from 2016 to 2018 he was IQ’s inaugural Chair of the Biologics CMC Leadership Group. He also serves on the biotechnology curriculum advisory board at Northeastern University.

Philip Vanek
Philip Vanek
Chief Technology Officer at Gamma Biosciences
Phil has more than 40 years of life sciences, manufacturing, academic, pharma, and Biotech experience. He worked in various companies like Trvigen, Invitrogen/Thermo, BD biosciences, Lonza, John Hopkins, GE Healthcare, CCRM followed by Gamma Biosciences.
Scott Cross
Scott Cross
Senior Principal, Head of Gene Therapy CMC at Dark Horse Consulting, Inc.

Scott has over 20 years’ experience working with viral vectors, vaccines and biologics in GMP environments. He has been responsible for cleanroom design and build out and commissioning of vector facilities, as well as the oversight of cell therapy, fill finish and manufacturing support departments.

Scott started his career at Merck and Co. where he worked on the development of an Adenovirus-based HIV vaccine and later, the development, optimization and validation of release assays for live virus vaccines. He then moved to Indiana University (IU) where he managed the IU Vector Production Facility (IUVPF), overseeing the GMP production and testing of Lentiviral and Retroviral vectors for the IUVPF and the National Gene Vector Laboratories (NGVL). While at the IUVPF he also managed the design, build and commissioning of a new viral vector GMP production and testing facility.

After leaving the IUVPF, Scott joined Cincinnati Children’s Hospital Medical Center (CCHMC) managing the GMP Vector Production Facility, Viral Vector Core and the Aseptic Processing Labs. Scott then moved to the University of Florida where he was the Director of Cell Therapy, Fill Finish and Manufacturing Support Operations for Florida Biologix and Brammer Bio. He was also responsible for the design of two new fill finish suites. Most recently, Scott served as Vice President of Vector Operations at Orchard Therapeutics where he was one of the original ten members and responsible for viral vector development, GMP vector production, plasmid production, oversight of 10 CDMOs, due diligence, and facility design. In 2020, Scott joined Dark Horse Consulting Group as a Principal and moved into a Senior Principal role in January of 2022.
Ramin Baghirzade
Ramin Baghirzade
Global Commercial Head Gene Therapy at Charles River Laboratories
Dr Ramin Baghirzade is the Global Head Commercial – Gene Therapy CDMO Services at Charles River Laboratories. With 15+ years of experience in life science and healthcare, Dr Baghirzade previously held roles of increasing responsibility at Roche, Lonza, and AGC Biologics in global business development, strategic marketing and market intelligence functions. He holds a PhD Degree in Medical Sciences, as well as an MBA.

SPEAKERS

Aaron Vernon
Aaron Vernon
Chief Manufacturing Officer at Quell Therapeutics
Palani Palaniappan
Palani Palaniappan
Chief Technology Officer at Flagship Pioneering
Philip Vanek
Philip Vanek
Chief Technology Officer at Gamma Biosciences
Scott Cross
Scott Cross
Senior Principal, Head of Gene Therapy CMC at Dark Horse Consulting, Inc.
Ramin Baghirzade
Ramin Baghirzade
Global Commercial Head Gene Therapy at Charles River Laboratories

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