INSIGHTS FROM THE SAE MEDIA CELL AND GENE THERAPY CONFERENCE
By Hamish Hogg
The Cell and Gene Therapy Conference, held on the 19th and 20th June 2023 at the Copthorne Tara Hotel, Kensington, brought together industry experts and professionals to discuss the development of Cell and Gene therapies and explore future innovations. The event featured discussions and presentations by cell and gene therapy experts, providing valuable insights on their progress and the path to delivering compliant and affordable therapies to patients.
Insightful Presentations by Industry Experts: The two-day exhibition featured informative presentations by subject expert speakers, offering attendees shared knowledge and practical advice. The opening speech was provided by Dr Giandomenico Turchiano, Associate Director, Gene Editing Safety, AstraZeneca. He expressed optimism about Cell and Gene Therapy, stating ‘It is working, and funding is coming, that will work towards curing a range of genetic disease.’ Showing a real investment and drive in this sector to provide advanced therapies to benefit patient outcomes for the future.
Another esteemed speaker: Chrysanthi Sitmalidou, Scientist II, Orchard Therapeutics, discussed developing a platform for GMP Lentiviral vector production. She made a comparison of suspension and adherent processes. She compared suspension and adherent processes and emphasized the need for endotoxin, mycoplasma, and sterility testing when transitioning to GMP after therapy development. She also highlighted the importance of identifying potential contamination, even in non-sterile processes, such as the presence of undesirable organisms.
Nagy Habib, Co-Founder and CMO, Dawn Therapeutics spoke about DNA testing, and stated ‘Can we fix it with Cell and Gene Therapy. The answer is yes.’ He cited the example of Hurler disease, where genetic therapies have significantly improved life expectancy and quality of life for patients. However, the high costs associated with these therapies, around $3 - 3.5 million per injection, pose a challenge. Dawn Therapeutics aims to reduce the cost by 95% through patented technology, making it more affordable at $30,000 per injection.
Cherwell's Contributions: Among the exhibitors, Cherwell showcased several solutions addressing the sectors environmental monitoring needs in compliance with GMP Annex 1. Notably, their new addition to the portfolio, the 'BAMS' (Biological Air Monitoring System). BAMS, an advanced airborne particle counter, enables real-time detection of inert and microbial particles, providing a comprehensive understanding of the cleanroom environment.
Engaging with Delegates: The Cherwell team had productive interactions with delegates, who sought advice and discussed their own environmental monitoring requirements. As these delegates were at the early stages of their Cell and Gene developments, there was a knowledge gap regarding scaling up the product while meeting GMP guidance and EN/ISO regulations. Cherwell showcased their extensive range of Redipor-prepared media, developed with customers' needs in mind over the past 40 years, offering reliable and high-quality solutions for cleanroom operations.
Reducing risk with the RediPortBag: Cherwell also highlighted the innovative RediPortBag, designed for quick and convenient sterility transfer of culture media used in environmental monitoring into isolator or RABS systems. The RediPortBag, compatible with Getinge La Calhene DPTE Alpha Ports of 190mm diameter, reduces decontamination cycles as it is fully irradiated. With four connections available, it minimizes waste by allowing clients to retrieve the required number of plates for a specific campaign.
Join Cherwell at the PHSS Annual Conference: We will be at the PHSS Annual Conference, to be held in London Heathrow 14th September 2023 with the venue to be confirmed, so please keep an eye on Cherwell’s social media for further information.
Conclusion: That's wonderful to hear that Cell and Gene Therapy has sparked a sense of energy and investment in the healthcare sector. The potential of these therapies to improve patient health is indeed significant. It's crucial to recognise that as these therapies progress towards becoming patient medicines, they will need to meet Good Manufacturing Practice (GMP) and EN/ISO regulations. Compliance with these regulations ensures that the therapies are produced consistently, with high quality, and adhere to safety standards.
Environmental monitoring plays a crucial role in the development and manufacturing of Cell and Gene Therapies. It helps maintain the integrity and sterility of the manufacturing environment, ensuring the safety and efficacy of the therapies. Cherwell's involvement in understanding environmental monitoring demonstrates a commitment to supporting the advancement of Cell and Gene Therapies.
With the increasing investment in this field, it's exciting to witness the progress being made and the potential impact on the future of medicine. Continued efforts in research, development, and collaboration will be instrumental in unlocking the full potential of Cell and Gene Therapies and improving patient outcomes. We look forward to continuing to support our customer in this area with the right solutions.
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Our revised and updated guide helps highlight decisions and actions to ensure you remain compliant.