Scaling gene therapy, mAb, or vaccine therapeutic drug products from bench to manufacturing involves a balancing act between project management, risk mitigation, and process parameter selection. A holistically-executed development that takes these into consideration can help identify and mitigate risks before they occur and protect the project budget – ultimately accelerating speed to market.
Join our Technical Director, Kevin Thompson, as he explores the ways Pall Corporation applies best practices through implementation of the Biotech Integrated Solutions service architecture for large-scale manufacturing projects.
Global Product Manager, Integrated Solutions
Dave is a Global Product Manager covering the Integrated Solutions program, responsible for marketing operations, outbound marketing and customer research. He joined us in 2016, bringing 11 years of both scientific and engineering experience in the areas of product development, project management, R&D and marketing. He holds degrees in both Microbiology and Mechanical Engineering from the University of Massachusetts, Amherst.
Technical Director, Pall Advanced Separation Systems (PASS)
Kevin is a Technical Director within the PASS team - a customer-focused process engineering and project management team responsible for delivering integrated solutions to the pharmaceutical industry. He has spent the last 40 years in Engineering, starting in the UK’s electrical supply industry, transitioning to Oil and Gas, followed by Chemicals and Polymers, with the last 22 years dedicated to Pharmaceuticals. He is located within our Center of Excellence in Portsmouth, UK, where he manages a group of project managers - process and commissioning engineers supporting global projects. His team was dedicated to the Astra Zeneca/Oxford COVID-19 vaccine project where their involvement started in the early process development phase, through to delivery.
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