Plasmid DNA (pDNA) is an important component of mRNA, vaccine, and viral vector therapies. Scaling and optimizing downstream processes during manufacturing requires an in-depth knowledge of all unit operations. This webinar presents a design for a generic manufacturing template that overcomes the challenges associated with the purification of pDNA (i.e high viscosity, large molecule size, shear sensitivity, and similarities with impurities). Key considerations for purification unit operations include harvest, lysis, clarification, tangential flow filtration, and chromatography to sterilizing grade filtration. The webinar presents a comprehensive case study encompassing all downstream unit operations.
In this webinar, you will:
- Get an overview of the pDNA market
- Receive guidance for filter selection as a replacement for centrifugation
- Learn purification strategies using AEX chromatography resins and membranes
- Understand key considerations for sterile filtration
- Learn about a complete purification process flow for pDNA
Speakers
Nargisse El Hajjami, Ph.D. Eng.
Merck
Senior Consultant
Nargisse El Hajjami, Ph.D. Eng. is a senior consultant for novel modalities and the global lead for mRNA technology within our bioprocessing strategy operationalization group. Nargisse is a molecular microbiologist and bioprocess expert with 11 years of experience combining scientific research, process development, and biomanufacturing engineering. In her current role, Nargisse focuses on novel modalities business development by leading strategic initiatives, supporting go-to-market strategies, providing directions to operationalize the business strategy, as well as supporting customers to build, grow, and optimize their manufacturing processes.
Thomas Elich
Merck
Manager, MSAT Americas Purification Process Engineering
Tom currently manages the MSAT Americas purification process engineering team, which is responsible for supporting end-users of Merck's solutions for chromatography, TFF, single-use, and systems technologies. Tom received his B.S. in chemical engineering from Northeastern University.
Laurens Vergauwen
Merck
Process Development Scientist
Laurens Vergauwen is an EMEA process development scientist and a global vaccine and viral therapies process development focal point lead. In this role, Laurens supports customers in the development and optimization of various downstream purification technologies (chromatography, TFF, clarification, sterile and viral filtration). Being able to work with different types of manufacturers has enabled him to gain knowledge about purification strategies for various biopharmaceuticals, including mRNA. He obtained his M.S. in industrial biochemical engineering at the University of Leuven (Belgium).
Pharma and biopharma manufacturing
- Downstream Processing
Durata:1h
Lingua:English
Sessione 1:tenuto March 24, 2022
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