Manufacturing Quality Control for Plasmid DNA Critical Starting Materials

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Manufacturing Quality Control for Plasmid DNA Critical Starting Materials

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

In today’s evolving advanced therapies ecosystem, plasmid DNA retains its common role as a critical starting material for a range of advanced therapeutic modalities, laying the foundations for mRNA, cell, and gene therapy production.

Given the importance of plasmids in the long-term success of complex programs, coupled with a range of manufacturing approaches and supplier quality standards, how can you ensure your plasmid products are fit-for-purpose?

In this webinar, our subject matter experts will cover common issues and quality control (QC) considerations from a manufacturing perspective. Explore case studies to demonstrate the importance of a robust QC strategy and learn how this supports the successful and timely delivery of advanced therapy manufacturing.

Offering bite-size presentations on three key areas, register to join our subject matter experts and come away confident in your knowledge of:

Current industry standards for plasmid DNA manufacturing quality and testing
Latest technologies and platform enhancements to streamline production with a focus on product quality
Key challenges in critical starting materials manufacture, including case studies for common plasmid types and what you need to know to safeguard development and manufacture

Leverage the expertise built through a concept to cure portfolio from discovery, safety assessment, and regulatory guidance through to phase-appropriate, scalable manufacturing, and get your therapies to the patients who need them most.

Andrew Frazer

Associate Director, Scientific Solutions at Charles River Laboratories

Since graduating with a PhD in biochemistry from Queen’s University Belfast, Andrew has attained over 10 years of experience in the design, implementation, and tech-transfer of processes for the manufacture of biocatalysts, small molecule APIs, and biologics. Andrew now holds a commercial role as Associate Director, Scientific Solutions within Charles River CDMO Services with a focus on the plasmid DNA manufacturing platform and service offering.

Lauren R. Salvitti

Research and Development Manager, Microbial Solutions at Charles River Laboratories

Dr. Salvitti manages the Microbial Identification R&D team at Charles River, in the Microbial Solutions division, and brings with her considerable experience in the molecular, microbial, and marine sciences. She has managed and conducted projects in numerous biological systems using a broad range of methods including next-generation sequencing, CRISPR, quantitative PCR, histology, and various microscopy techniques. Dr. Salvitti received her MSc in Marine Biosciences from the University of Delaware, and her PhD in Biological Sciences from the University of Waikato.

Shane Lovatt

QC Manager - Analytics at Charles River Laboratories

Shane joined Charles River’s contract development and manufacturing (CDMO) site in Keele in 2015; initially employed within GMP Manufacturing Operations, he transitioned to the Quality Control department around 6 years ago. As QC Manager for the analytics team, his role oversees release and stability testing of plasmid DNA products which are to be used as Bulk Drug Substances or Critical Starting Materials used in viral vector manufacture.

Jon Brook-Jones

QC Principal Scientist - Analytics at Charles River Laboratories

Since joining the Charles River Keele contract development and manufacturing (CDMO) facility as a Quality Control Scientist in 2003, Jon has spent the last two decades honing his technical expertise, reaching the position of Principal Scientist in 2022. As a QC subject matter expert, Jon is primarily focused on method development, validation, and release/stability testing of plasmid DNA products.

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