Implementing Single-Use Technologies In Formulation And Filling Of Vaccines
Implementing Single-Use Technologies In Formulation And Filling Of Vaccines
Formulation and filling is a critical part of any drug manufacturing process and demands the highest levels of quality and reliability. Pall has a range of technologies and services that enables end users to carry out their operations with increased reliability and flexibility – while ensuring the product quality is designed into the manufacturing process. Using technology from the Allegro™ single-use portfolio, Pall sterilizing grade filters and Pall’s automated solutions ensure that manual interventions are minimized and increased sterility assurance is achieved.
Speakers
Patrick Evrard
Senior Principal Engineer Single-Use Technologies,
Technical Communication and Regulatory Strategy
Patrick joined Pall Biotech in 2017, to provide expert technical support to Pall Biotech's customers on single-use systems. He joined end 2018 the Technical Communication and Regulatory Strategy team, combining the technical content with validation and regulatory perspectives.
Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.
Helene Pora
VP Technical Communication & Regulatory Strategy
Helene 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 30 years of experience working for the biopharmaceutical industry, the last 29 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 interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
Vaccine Production: Securing process quality with flexible manufacturing solutions
Pall’s innovative process technologies have been an important contributor to the success of many vaccine production processes, and we are constantly working with the industry to enhance our solutions to meet new vaccine development and manufacturing challenges.
Biotech Research & Commercialization Solutions | Pall Corporation webinar series
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