Join industry experts to get an overview of the current regulatory guidance for QC testing of mRNA/LNP-based products and the impact of limited existing guidance on QC testing for mRNA/LNP developers. Learn more about how to maximize product yield, ensure the highest quality, and optimize costs with our next-generation fill and finish services. Gain insights on tailoring the immunogenicity profile from prophylactic to therapeutic applications through an mRNA-LNP vaccine platform, reducing reactogenicity, and extending shelf-life stability.
This symposium will be chaired by Eleni Samaridou, Ph.D., a prinicipal scientist in the early formulation screening services team at MilliporeSigma.
In this symposium, you will learn how to:
- Utilize isolator filling technology in the manufacturing process of your LNP
- Navigate the current regulatory landscape for quality control testing of mRNA/LNP products
- Tailor the immunogencity profile in an mRNA-LNP vaccine platform to extend the shelf-life stability and reduce reactogenicity
Speakers
Jason Vaughn
MilliporeSigma
Site Head of Technical Operations
Jason is the site head of technical operations at MilliporeSigma's Drug Product and LNP Center of Excellence in Indianapolis. He previously worked in the CDMO industry for 4 years, leading drug substance and drug product manufacturing teams and the site MS&T/technical support and validation team. Jason also directed a commercial plasma fractionation operation for more than 12 years. He holds a bachelor’s degree in science, Six Sigma and Lean certifications, and General Manager Leadership certifications.
Pamela Hamill, Ph.D.
MilliporeSigma
Technical Consultant, Global Scientific and Regulatory Consultancy
Pamela is a technical consultant in MilliporeSigma's contract testing services team, supporting clients with scientific, technical, and regulatory advice related to the quality control testing required for the development and commercialization of biological therapies and novel modalities. She previously worked as a principal scientist in our contract testing services UK facilities, overseeing clients' custom cell-based and immunoassay development and providing associated technical and regulatory support. Pamela has a Ph.D. in virology from the University of Glasgow.
Roland Böttger, Ph.D.
CureVac
Senior Scientist
Roland Böttger received his Ph.D. in chemistry from University of Leipzig (Germany) in 2018 and completed postdoctoral training focused on nanomedicine at University of British Columbia (Canada) in 2020. He is now a senior scientist at CureVac (Germany), developing mRNA delivery systems for prophylactic and therapeutic vaccine applications. In addition, he works on liquid and dried mRNA presentations with improved stability.
Eleni Samaridou
MilliporeSigma
Principal Scientist, Early Formulation Screening Service
Eleni is a principal scientist in the early formulation screening service team. She is a chemical engineer by training and holds a MSc in biochemistry and a Ph.D. in nanomedicine, followed by postdoctoral research experience on advanced drug delivery. Eleni brings more than 8 years of hands-on experience on the development of lipid-based formulations for RNA delivery applications, having served previously as a scientist at BioNTech SE, Mainz, Germany, and, at Genevant Sciences, Vancouver, Canada.
Pharma and biopharma manufacturing
- mRNA
Duración:1h 30min
Idioma:English
Sesión 1:presentado October 8, 2024
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