Accelerate Your Upstream Bioprocess
Accelerate Your Upstream Bioprocess
What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to reliably and efficiently produce them. The capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.
Bioreactors have long been a critical part of the cell culture process, and presented challenges when it comes to moving from PD to cGMP manufacture. The first single-use bioreactors were introduced around 25 years ago. Since then, the evolution of single-use technology has brought many benefits, such as closed gamma irradiated biocontainers and scalable systems. As a result, single-use bioreactors are increasingly used for small-scale, mid-scale and large-scale production runs.
In this webinar, we will present case studies illustrating the benefits of leveraging industry experts, proven methods, and integrated upstream solutions to design a robust, scalable and reproducible process.
Participants will learn:
- Strategies for transferring scalable processes from pre-clinical to cGMP commercial manufacturing
- How partnering with Pall’s Accelerator℠ process development services team will help reduce time to market
- Innovative single-use bioreactors whether you are growing adherent or suspension cells
Group Leader, Upstream Technologies
Group Leader for upstream technologies for Pall Biotech Product management, Joe has worked for Pall since 2014, and has over 15 years’ industry experience in the upstream space. Prior to his tenure at Pall, Joe held various cross functional roles in marketing, sales, technical applications, as well as a cell culture associate in a commercial manufacturing cGMP environment. He has a Bachelor of Science from the University of Rhode Island, Masters of Business administration from the University of New Haven, and Master of Science in Biotechnology from Johns Hopkins University.
Manager, Cell Culture Applications, Scientific and Laboratory Services
Andrew brings many years of experience to Pall Biotech and is responsible for managing a team of bioreactor application scientists within the APAC region to support customers and commercial colleagues in upstream gene therapy, cell therapy and biologics applications. Prior to this, he managed a team of R&D scientists to provide cell culture media and process development services for customers. Andrew holds a PhD and BSc (Hons) from Murdoch University, Perth Australia. His research includes the investigation of the physiological importance of the proteins of interest of infectious and cancer diseases, completed as part of his postdoctoral fellowship, PhD and Honors degrees where he supervised PhD, honors and undergraduate students. Andrew has developed a patent and his work is published in several journals.
Byron J. Rees
Senior Manager, Scientific and Laboratory Services
Byron received his BSc in Pharmacology from the University of Portsmouth UK. He has gone on to work in QC for microbiology and analytical chemistry at Pfizer. Since joining Pall in 2006 Byron has worked on all of Pall’s bioreactor technology developments and been the lead for R&D Applications on the STR range. Currently Byron manages the UK Pall Biotech Process Development laboratory where he is responsible for upstream and downstream process development projects in gene therapy, vaccine and monoclonal antibody production.
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