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.
Biotech | Pall Corporation webinar series
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