Fast Access To GMP-Grade Plasmid DNA

Capabilities

Product Characterization and QC Analytics

Recorded: September 2022

This webinar shall discuss the global challenges of accessing GMP-grade plasmid DNA to support gene therapy product manufacture and how Pharmaron’s capabilities can help alleviate such bottlenecks.

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Key Messages on Plasmid DNA:

The demand for GMP-grade plasmid is high and continuing to grow – however, demand is out-pacing supply
Pharmaron can reduce timelines with regard to Gene Therapy product manufacture by providing access to:
- AAV pDNA constructs and MCBs & purified plasmid stocks
- Scalable production processes to deliver GMP-grade pDNA (Animal-free and exploits SU-tech, scalable)
- A panel of in-house Analytical Methods to support the release of GMP-grade pDNA
New technologies can improve our characterization of pDNA products, helping us to control the quality of pDNA delivered to the customer (SCIEX)

Agenda:

Introduction to Plasmids
- What are they?
- Why are they essential in the context of Gene Therapy products?
- What does the global demand for GMP-grade pDNA look like?
What are the challenges associated with procuring GMP-grade plasmids for use?
- Availability of manufacturing slots/Timelines
- Management of multiple 3^rd party vendors (e.g. pDNA manufacturer/AAV manufacturer)
- Quality of purified product
How can Pharmaron help to remove bottlenecks
- Access to Pharmaron AAV constructs and purified plasmid stocks
- Scalable pDNA manufacturing process capable of producing gram-level quantities of GMP-grade pDNA
- An in-house panel of analytical methods available to support the release of GMP-grade pDNA
- Co-location of pDNA/HEK cell banking/AAV manufacture activities simplifies supplier management
Capillary Electrophoresis can be used to separate pDNA isoforms with high resolution, supporting a better understanding of the quality of our pDNA products

Meet our Speakers

Presenters:

Robert Seymour, Senior Technical Specialist, Process Sciences at Pharmaron Gene Therapy

Rob is a Senior Technical Specialist within the Process Sciences team at Pharmaron Gene Therapy. Rob possesses a BSc in Biology w/Statistics and has over 15 years of industrial experience, largely spent developing Downstream Purification solutions for a wide range of biomolecules, including recombinant proteins, viruses and pDNA. Within his role at Pharmaron, Rob has been responsible for establishing in-house manufacturing capabilities concerning plasmid DNA and continues to support the continuous improvement of DSP processes.

Ryan Hylands, Senior Technical Specialist, Analytical Sciences at Pharmaron Gene Therapy

After graduating from the University of East Anglia, Ryan has attained over 12 years experience within Biopharma R&D and Biologics in various analytical roles, previously working with LC-MS for the analysis of recombinant proteins and peptides. He is currently a Senior Technical Specialist within the analytical team at Pharmaron, focusing on developing HPLC and CE methods to support both viral and plasmid analysis for AAV manufacture.

Dr Stephen Lock, Senior Marketing and Market Development Manager at SCIEX, BioPharma EMEAI

Dr. Stephen Lock obtained his PhD in Physical Organic Chemistry from the University College of Swansea in 1993. He is a chartered chemist and a member of the Royal Society of Chemistry. Previously a lecturer of Chemistry at the University of Hull and a Senior Scientist at CCFRA he has worked for SCIEX™ in various technical roles for over 20 years. He has over 25 years of experience in Analytical Chemistry and has presented at over 80 international meetings worldwide.

Steve is currently the EMEAI BioPharma Senior Market Development Manager for SCIEX and is also an Adjunct Professor at the University of Pannonia, where he acts in a volunteer role as a Scientific Advisor for the Horváth Csaba Memorial Laboratory led by Prof. Andras Guttman. At the Horváth Csaba Memorial Laboratory, Steve provides technical advice and supports the group’s fundamental research and development of new applications in CE and CE-MS.

Fast Access to GMP Grade Plasmid DNA