Assessing extractables & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term storage.
By Engaged ExpertNick Morley
Principal Scientist for Life Sciences Manchester, Nick Morley has over 15 years of pharmaceutical laboratory experience predominantly specializing in extractables and leachables.
Nick Morley delves into extractables and leachables testing for cell and gene therapy products in a concise, free-to-view, pre-recorded webinar. Discover the nuances of this critical testing through valuable cell and gene therapy insights, essential considerations, and best practices for product safety and regulatory compliance.
The impact of solvents and long-term storage on E&L profiles
This webinar offers invaluable insights and case studies showcasing the impact of solvents and long-term storage on extractable and leachable profiles. It addresses how freezing and thawing affects leachable profiles, showcasing how storage conditions might impact extractable levels, supported by real-life examples and data.
Navigating the regulatory landscape for long-term storage
Discover the evolving regulatory landscape and the crucial need for detailed studies of materials used in the long-term storage of these transformative therapies. Uncover the significance of employing a methodical strategy that aligns with the principles of quality risk management.
Critical to patient safety
The webinar is pertinent to professionals involved in pharmaceuticals, medical devices, regulatory affairs, and quality control seeking a deeper understanding of extractable and leachable testing's impact on patient safety and regulatory compliance.
Why should I watch this webinar?
In this webinar, Nick tackles the following:
- The challenges faced in leachable risk assessment for revolutionary treatments.
- Designing and executing extractable & leachable studies for disease treatment through advanced therapy medicinal products (ATMPs).
- How to navigate the evolving regulatory landscape for cell and gene therapy products in long-term storage.
Key cell and gene therapy insights
- Introduction to Cell and Gene Therapy Products: We define and differentiate cell and gene therapy products, highlighting their disease-treating aim via the genetic material in live cells, emphasizing unique features in batch sizes, dosing, storage, equipment, and administration methods.
- Understanding Extractables and Leachables: The importance of assessing potential risks and impacts of extractables and leachables in these products. We cover systematic approaches for risk management, identifying potential sources of leachables, conducting risk analysis, and designing studies to address gaps in knowledge.
- Case Studies: For materials like polyethylene bags and PTFE tubing, we showcase how different solvents and conditions affect extractables. These studies highlight the importance of understanding solvent interactions and storage conditions to mitigate risks.
- Long-Term Storage Impact: The impact of freezing and thawing on leachable profiles, demonstrating how storage conditions could influence extractable levels, emphasizing the need for simulation studies to mimic real-world scenarios.
- Standards: The webinar stresses the importance of using a systematic approach aligned with quality risk management principles, such as those outlined in ICH Q9. It also emphasizes leveraging existing standards like USP 87 and 88 for biological reactivity testing and USP 661 for plastic materials.
Watch our Cell and Gene Therapy Insights Webinar
Take advantage of this chance to understand how extractable and leachable testing plays a vital role in securing the safety and effectiveness of cell and gene therapy products.
Access the webinar now to gain invaluable insights shared by industry expert Nick Morley.
For inquiries or further information, contact us directly. We're here to address your concerns and guide you through this critical aspect of product development.
Assessing extractables & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term storage - Excerpt.
"Understanding the product and gathering as much information beforehand can determine knowledge gaps and guide appropriate studies, documenting the rationale for study design based on sound scientific justification is key."
About the author
As a trusted authority within the Life Science industry, Nick provides clients with technical guidance for design studies, authors whitepapers, presents at conferences and collaborates with external scientific organisations to keep up to date with the latest trends.
Nick is passionate about helping our clients deliver innovative products that enable patients to live healthier and more comfortable lives.Nick Morley
Extractables & Leachables Studies
Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
Backed by regulatory expertise, extensive experience, and a vast extractables database, our comprehensive E&L solutions ensure the safety of materials used across the healthcare sector.
We deliver tailored studies for pharmaceutical, biologic, medical device, reduced risk, combination products and more, in accordance with regulatory expectations.READ MORE
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
ISO 18562 Testing: Biocompatibility Analysis
Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
USP 665, 1665 and BPOG Services
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
ICH Stability Testing of Pharmaceuticals and Biologics
We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs.