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Bridging the Development Gap: From Research to GMP-Ready Cell Lines

In the world of cell-based therapies, transitioning from research to GMP (Good Manufacturing Practice) compliance often presents a series of hurdles. Numerous factors can impede this process, including inconsistent documentation, manual workflows, and a lack of early quality planning. These challenges are not only relevant in academia but are prevalent in the industry as well.

To address these complexities, an upcoming free webinar titled "From Research to GMP-Ready Cell Lines: Bridging the Development Gap" is being hosted by Xtalks on October 14, 2025. This informative session will offer valuable insights into how to effectively navigate from laboratory research to compliant manufacturing processes.

Key Insights from the Webinar

The session will feature expert speakers, including Dr. Zoe Hewitt, Co-Founder and CEO of Regenerative Cell Therapy Consulting (Regen CTC) Limited, and Camilla Domeneghetti, Biology Manager at Advanced Instruments, LLC. They'll explore several pertinent strategies and real-world case studies showcasing successful transitions to GMP compliance. Here’s how the webinar promises to elevate your understanding:

• - Expert Consultancy: With years of experience, the panel will provide insights on how consultancy services can play a pivotal role in ensuring compliance. They will discuss how skilled professionals analyze workflows and identify critical areas that require attention, making the GMP transition smooth and efficient.
• - Automation Platforms: The advent of modern automation platforms has revolutionized workflows for cell line development. The speakers will delve into the best practices for selecting and implementing scalable tools that assist in overcoming common difficulties posed during the transition to GMP compliance.
• - Real-World Case Studies: One of the highlights of the webinar will be the detailed discussion about a specific project where a cell line, previously selected manually, underwent regeneration while adhering to all GMP requirements. This example will demonstrate the methodology and thought process behind decisions made during the project.

Importance of Compliance in Cell-Based Therapies

Compliance with GMP is crucial, especially in the realm of biomedical research. The requirement serves as a regulatory foundation that assures the quality and safety of cell-based therapies for clinical applications. As FDA and global regulatory standards evolve, aligning research efforts with these guidelines is not just beneficial but necessary for advancing therapeutic solutions to market effectively.

Who Should Attend?

This webinar is tailored for professionals across the biotechnology and pharmaceutical industries, including researchers, quality assurance specialists, and anyone involved in the manufacturing process of cell-based therapeutics. By participating, you'll gain critical knowledge that can propel your compliance initiatives forward.

How to Register

To participate in this insightful webinar, interested individuals can register through the Xtalks website. Spots are limited, so early registration is encouraged. Attendees can choose from two broadcast options: one aimed at audiences in the UK and Europe at 9 am BST (10 am CEST), and another aimed at North America at 8 am PDT (11 am EDT).

In conclusion, bridging the development gap for GMP-ready cell lines is a journey fraught with challenges. However, with the right strategies in place, driven by expert insights, companies can navigate this critical phase successfully. Ensure your place in this important discussion that could shape the future of compliant cell manufacturing.

For further details about the webinar and to secure your registration, please visit the Xtalks official site.