Downstream Process Development For Vaccine Manufacturing

Downstream Process Development For Vaccine Manufacturing

 

The purification of vaccines and gene therapy/viral vector products is a key part of a drug manufacturing process that requires high levels of product purity and process reproducibility. Pall has a range of technologies and offers field-based support and lab-based process development services that enable end users to purify and recover their high-value products. The process strategies to improve purity and yield as well as the challenges associated the purification of viral vector process will be discussed.

Speakers

Jon Petrone

 

Senior Director, Process Development Services and Scientific Laboratories Services Consultancy Teams supporting Purification, Viral Vector and Gene Therapy Technologies

 

Jon leads Pall Biotech’s Process Development Services (PDS) and SLS consultancy teams supporting purification, viral vectors, and gene therapy technologies. The PDS team provides upstream, downstream, and analytics process development, scale-up, and tech transfer services to support emerging therapeutics such as gene/cell therapies (and proteins) as well as supporting new manufacturing methods such as continuous bioprocessing. 

 

The SLS consultancy teams provides field-based customer and technical support that utilizes Pall’s technologies and products to create process solutions for the production and purification of biopharmaceutical products, such as viral vectors, monoclonal antibodies and gene therapy products. 

 

He has over 35 years of experience supporting downstream purification applications from cell harvest through final bulk fill. Prior to joining Pall 15 years ago, Jon was responsible for the process development and clinical/commercial support of the membrane based separations and centrifugation steps at Wyeth BioPharma. Previously, he held various applications/product development and system sales roles at Millipore.

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.

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April 2022
Getting Ready for SUT X-Ray Irradiation

Biotech | 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
Watch