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.
Cell and Gene Therapy Thought Leadership and Publications
As a trusted plasmid DNA manufacturing subject matter expert, Dr. Frazer has contributed to several webinars, white papers, articles, and discussions addressing key challenges in the advanced therapies field.
CGT Summit
Panel Moderator - The Cell & Gene Therapy Journey: Discovery to Commercialization
Explore all expert insights and download your copy of the eBook: Insights From the Front Lines of Cell & Gene Therapy.
Webinars
- Advancements in Manufacturing for Rapid Delivery of pDNA Starting Materials
- Case Study: Sustainable Plasmid DNA Strategies
- Expediting Development and Manufacture of Advanced Therapies
- How to Future Proof Your Plasmid Supply and Avoid Common Pitfalls
- Manufacturing Quality Control for Plasmid DNA Critical Starting Materials
- Navigating Industry Challenges to Drive Sustainable Plasmid DNA Strategies
- The Role of Plasmid DNA in Expediting Gene Therapy Manufacturing and Beyond
Plasmid DNA Manufacturing Whitepaper
Not just a starting material, pDNA directly impacts the integrity and functionality of your final product. Drawing on 20+ years of CDMO expertise, explore essential quality controls and proven strategies to safeguard your program.
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Articles
- Expediting Development and Manufacturing of Advanced Therapies: Critical Starting Materials Case Studies | Cell & Gene Therapy Insights
- Takeaways from the In Vivo Gene Therapy Symposium
- Overcoming Challenges in Obtaining Plasmids | GEN
- Picking a CDMO as a CGT Developer: What to Consider and Why | Manufacturing Chemist
- Moving Cell and Gene Therapies from Potential to Patients | European Pharmaceutical Review
Podcast - Andrew Frazer is joined by Amanda Weiss, VP of CMC, Purespring Therapeutics
Q&A with Andrew Frazer, PhD
Q: What inspires you about supporting clients developing new cell and gene therapies?
AF: Cell and gene therapy is still such a new and exciting field with so much potential. With scientific development moving at such a fast pace, we have a key role as an experienced manufacturing service provider to ensure that our clients can transfer their products to patients in a safe and efficient way. Seeing first-hand how novel ideas and approaches can become life-changing treatments is truly inspiring.
Q: What excites you most about the evolution of plasmid DNA technologies for gene and cell therapy programs?
AF: Plasmid retains a key role for a wide range of advanced therapy modalities, and it is exciting to see new applications within non-viral delivery and genome editing. As the field develops, there is a clear expectation for greater efficiencies to support reduced cost of goods and faster timelines for plasmid production. Manufacturing and testing technology solutions have resulted in clear improvements in recent years enabling manufacture of plasmids at a range of scales while ensuring that quality is never compromised.
Q: What challenges do developers typically encounter when scaling plasmid DNA production for early-phase clinical programs?
AF: The transition to clinic holds a number of challenges for developers whose products rely on plasmid DNA. These can be technical challenges like stability, yield or compatibility with onward manufacturing approaches, but it is sometimes issues like intellectual property or licensing restrictions that are often overlooked by early-stage developers. These types of issues can cause significant disruption, particularly if they are not identified early. Working with an experienced manufacturing partner who can support and advise across all aspects of plasmid delivery can provide a significant opportunity to resolve issues early and lay the foundation for successful clinical and commercial production.
Q: How does plasmid design impact downstream vector manufacturing success?
AF: Promoters, complexity and size of payload, orientation and proximity of features and the overall size of plasmids can influence transfection efficiency, yields and quality of viral vector products. Understanding core architecture and how it relates to the specific onward application is critical. In addition, to ensure a safe product that is compliant with regulatory expectations, it is important to assess safety and ensure that redundant sequences have been removed.
Q: What quality attributes or analytical specifications are most important when selecting a plasmid DNA supplier?
AF: For product quality attributes and specifications related to plasmids, regulatory guidance has improved in recent years and the basic testing and associated specifications required for different applications of plasmid DNA is relatively clear. However, when selecting a plasmid supplier, pay close attention testing methods, reported values and the level of method validation as standards can vary significantly and it is important to align with the specific onward application.
Q: What advice would you give teams moving from research grade to GMP plasmid production?
AF: Early planning and developing a clear strategy for manufacture cannot be over-emphasized. Undertaking a detailed review of your plasmid products, their safety, compliance and compatibility with your chosen manufacturing approach are minimum requirements to ensure a smooth transition from research to clinical manufacture. Understanding gaps or limitations at an early stage allows time to resolve issues and avoid costly and time-consuming delays.
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