Gene therapies provide innovative options for treating patients, particularly where other traditional therapeutics have been ineffective. The industry continues to grow and mature from research to approved therapeutics. The latest industry trends and innovations have been detailed in the ebook, "Insights on Successful Gene Therapy Manufacturing and Commercialization" where thought leaders share their perspectives.
In this panel webinar, hear directly from the authors on various topics related to gene therapy downstream manufacturing and commercialization, the current state of the industry, and how we can continue to advance these life-changing medicines.
Cell Culture Dish & Downstream Column
Brandy Sargent is the Editor in-chief and frequent author of The Cell Culture Dish and The Downstream Column. She has worked in the biotechnology industry for over twenty years, first in corporate communications and public relations, then in technical sales and marketing, and most recently as a writer and publisher. She strives to introduce topics that are interesting, thought provoking, and possible starting points for discussion by the biomanufacturing community. She has been fascinated by the different applications of biotechnology since she first started working in the industry and continues to be fascinated as the industry evolves.
Tony Hitchcock has over 35 years of experience in the large-scale manufacture of biopharmaceuticals. As a founding staff member of Cobra, Mr. Hitchcock has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. He has held a number of senior roles, managing both manufacturing and development functions within the company, working on over 40 programmes for the development of novel therapeutic products including protein, recombinant virus, bacteriophage and plasmid DNA products.
His current role is based in the commercial group and supports external collaboration and outreach activities.
Clive Glover, PhD
Director, Gene Therapy Strategy
Dr. Clive Glover is Director of Gene Therapy Strategy at Pall Corporation, part of Danaher. Clive has wide ranging experience developing manufacturing tools for the cell and gene therapy space including stem cells, T cell therapies, and viral vector production. He has held business development, marketing, and innovation positions at STEMCELL Technologies, GE Healthcare Lifesciences (now Cytiva), and Pall Corporation. He obtained his PhD in Genetics from the University of British Columbia.
Mark Schofield, PhD
Senior R&D Manager
Dr. Mark Schofield holds a Ph.D. from the University of Dundee. He has 15 years’ experience in R&D and new product development for biopharma related industries. He currently leads the chromatography applications team at Pall developing continuous processing solutions.
Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare
The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.
Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.
You will learn more about:
- Why this is a critical change for industry and the responsibilities of each stakeholder
- Key questions to address for biomanufacturers
- How gamma and X-ray irradiation compare
- What testing has been completed and key milestones for readiness for industry
- An example of how to qualify a SUS sterilized with X-ray irradiation