How industry collaboration drives single-use technology standardization for fast and reliable implementation
The accelerated expansion of manufacturing facilities needed for COVID-19 vaccines has driven the implementation of single-use technology (SUT) across many sites worldwide. How new systems get implemented varies, and each supplier has a different approach to supporting end-users. However, all SUT projects require an iterative process and multiple touchpoints between biomanufacturers and suppliers to ensure quality, regulatory, and technical requirements are met.
This webinar, presented jointly by Krystal Biotech and Pall Corporation, focuses on collaboration between biomanufacturers and suppliers, and looks at how partnerships at industry level and on a one-to-one basis can speed up single-use process implementation and reduce risk.
You will learn more about:
- Key topics and challenges within the SUT industry
- The collaboration landscape in SUT
- Importance of collaboration: end-user and supplier perspectives
- How digital solutions, including virtual reality, have become a key enabler of collaboration
Dr Hélène Pora
VP Technical Communication & Regulatory Strategy
Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 35 years of experience working for the biopharmaceutical industry, the last 30 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interest groups with a strong focus on BioPhorum, and BPSA.
Mark Petrich (PhD)
Vice President, Technical Operations
Krystal Biotech, Inc.
Mark has an extensive experience in manufacturing, engineering, R&D, quality, and supply chain in large and small biopharma organizations. He’s an advocate for standards and collaborative efforts in the industry. Currently, he is the First Vice-Chair on the Executive Board for BPSA.
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 (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