BioPhorum Advanced Therapy Medicinal Products

BioPhorum Advanced Therapy Medicinal Products is delighted to announce that our latest publication ‘Mapping the regulatory landscape of Visible Particles in ATMP’ is now available. This members-only deliverable seeks to summarize the current guidance associated with visible particle controls. It also:   Highlights challenging aspects in current guidance Flags specific aspects which are not directly applicable for ATMP products considering the unique characteristics of these product types Provides a review of similarities and differences between US and EU guidance Summarizes key warning letters issued on the topic of visible particles.   Congratulations and thanks to all the BioPhorum Advanced Therapy Medicinal Products Visible Particles workstream members who contributed to the thinking behind this important paper. And a particular shout-out to the key authors - Shankar Swaminathan, Ph.D., Dora Sviben, Rafi Mohammad and Ken Green. Thank you all for your support.   BioPhorum Advanced Therapy Medicinal Products members can download the ‘Mapping the regulatory landscape of Visible Particles in ATMP’ paper here: https://lnkd.in/eurKsR97 (Members only)   To find out more about BioPhorum Advanced Therapy Medicinal Products’ workstreams and publications, and for information about how you can join our community of experts, please contact us via our LinkedIn profile page or email us at hello@biophorum.com.

Best of luck to Ane Quesada Ganuza, Senior MSAT Scientist at Viralgen (Bayer) who will be presenting a poster at the European Society of Gene & Cell Therapy 31st Annual Conference in Rome, Italy on 24 Oct 2024 [P0841]. Ane will be showcasing one of BioPhorum Advanced Therapy Medicinal Products’ recent publications ‘Leveraging platform and process characterization data to accelerate CGT validation and commercialization’. If you will be in Rome for the conference, please do go and say hello to Ane. She will be very happy to talk with you about BioPhorum Advanced Therapy Medicinal Products and about the paper she is summarizing. You can download a full copy of this here: https://lnkd.in/euuCKFca Alternatively, for further information about BioPhorum and how you can join our community of industry leaders please email hello@biophorum.com or visit: https://lnkd.in/ehjxhQfe

With the ATMP field continuing to expand, there is a growing reliance on contract development and manufacturing organizations to support ATMP licence holders.  Although working with contract organizations is not a new situation, it cannot be assumed that transferring an ATMP product to a contract organization will be the same as previous non-ATMP transfers.  You can read more about this here: https://lnkd.in/eAgyVktc  Or listen to our podcast episode relating to this matter here: https://lnkd.in/e6tfkrYQ Within the paper, members of BioPhorum Advanced Therapy Medicinal Products highlight unique cell and gene therapy considerations that need to be factored in above that of the standard transfer challenges to a contract organization (or between sites of the same organization).  As BioPhorum includes members from all stakeholder groups for this process, the discussions and resultant article provide the full view of challenges for all organizations, rather than a single perspective. The identified challenges have been grouped by:  Process design  Analytical methods  Supply chain  Facility and equipment, and  Regulatory and quality.  By understanding the challenges in these areas, it will support more efficient product transfers and prevent potentially costly delays that could occur due to being unaware of the unique considerations for cell and gene therapy products. For further information on BioPhorum Advanced Therapy Medicinal Products’ other publications visit: https://lnkd.in/exqf9Khu    #ATMP #celltherapy #genetherapy #RNA #transfer #contractorganizatons

Following on from our post earlier this week on reducing the impact of testing on the final batch yield of gene therapies, we would like to re-introduce you to two other publications which will help conserve final batch yield. https://lnkd.in/dheyyhtJ https://lnkd.in/eQm8PnBz In addition to stability testing, showcased earlier in the week, BioPhorum’s Minimizing the Impact of Testing on Batch Yield team also highlighted how the current expectations for Bioburden & Sterility testing, and Container closure integrity testing can also notably reduce final product yield. Again, the team discussed each of these tests for how they impact final yield and shared experiences, options, and justifications to reduce the amount of testing to be performed. The resultant 2 publications – linked above - capture all the proposed strategies that can be considered to help reduce testing, whilst maintaining compliance and delivering a quality product, and enable a greater final batch yield to provide more for the patients. For further information on the published work of BioPhorum Advanced Therapy Medicinal Products members, visit: https://lnkd.in/eQm-YA_e #genetherapy #celltherapy #bioburden #sterility #CCI #containerclosureintegritytesting

Advanced Therapy Medicinal Products is a rapidly growing field, however the scale of individual batches is still small compared to large molecule biopharmaceuticals. As current guidance may still base its testing requirements on larger batch sizes, challenges tend to arise where the guidance is not suited to the smaller scale of gene therapies, and particularly cell therapies. With this in mind, a group of cross-industry experts within BioPhorum Advanced Therapy Medicinal Products sought to collaborate to identify the testing areas that have the greatest impact on a product's final yield. You can download their findings here: https://lnkd.in/eWbPmFXA Or watch the webinar here: https://lnkd.in/gtqF7q4t With stability testing having a dramatic reduction in final yield, BioPhorum expert members focused on its challenges to identify strategies for reducing the volumes required for stability testing. The goal was to conserve product for the patient, whilst remaining compliant and delivering data on the stability CQAs. The team also applied these recommendations to a theoretical mock AAV gene therapy product and showed they could save up to 44% of a final drug product yield if following their strategies rather than the current guidance more suited to large molecule biopharmaceuticals. To find out more about the further recommendations resulting from this collaboration, download the document via the link above or contact the BioPhorum Advanced Therapy Medicinal Products team via hello@biophorum.com. #gene therapy #cell therapy #stability 

Today marks the end of BioPhorum Advanced Therapy Medicinal Products’ 3-day virtual event ATMP19. It has been great to see our members sharing case studies and updates on the activity they are driving forward within numerous workstreams. During today’s session, there were detailed presentations on viral safety in cell therapy, visible particle control strategies, viral vector impurities including process-related impurities, and dsRNA impurities for mRNA therapies. As well as so many learnings across the day and the full 3-day event, it was also wonderful to hear the ongoing activities of the teams and the direction we are working towards collaboratively across BioPhorum Advanced Therapy Medicinal Products. A further thank you to all attendees and today’s speakers: Horst Ruppach, Dana Schreffler, Gneya Pandya, Shankar Swaminathan, Ph.D., Rafi Mohammad, PhD, Sarah B., John Vergara, Steve Henry, Marija Brgles, Ashton Lavoie, Andrew Duckworth, Pamela Hamill, and Conor R. Lake And a huge thank you to the BioPhorum Team for organizing such a fantastic meeting: Niamh O'Kane, Simon Walker, Kathleen O’Hagan, Daniel Lister, Evelyn Camon, and Louisa Mitchell #AdvancedTherapies #CellTherapy #GeneTherapy #RNAtherapies #impurities #contaminants

Day two of the BioPhorum ATMP19 virtual event has been focused on the challenge of viral clearance in gene therapies.   Following an overview of viral safety considerations for ATMPS, several of our members shared case studies on their experiences with viral clearance. It was valuable to hear about and learn from the collective experience of the industry – truly showing the power of BioPhorum collaboration!   The day concluded with a panel discussion, where members had the opportunity to raise several questions with today’s speakers which were then discussed openly with all attendees to learn from. Thank you to all today’s attendees who played their part in making day two a great success, and also to our fantastic speakers: Kathryn Remington, Srivatsan Ramesh, Jason Morais, Noah Horn, John Ruppino, Hannah Seo, Richard Yu-Tsan Liu, Delaney Dowdell Tomorrow will be the final day of ATMP19, and we will be closing out the event by hearing from members of our active workstreams discussing critical challenges within the category of ‘Impurities & contaminants’. #AdvancedTherapies #CellTherapy #GeneTherapy #RNAtherapies #viralclearance #viralsafety 

Today marks the end of day one of the BioPhorum Advanced Therapy Medicinal Products 3-day virtual event (ATMP19), focusing on impurities and contaminants within ATMPs. Today’s focus was on extractables and leachables, with a great opening presentation from our guest speaker from the FDA – Dr Andrey Sarafanov. This was followed by a member case study on rapid screening of impurities; and then an overview from the BioPhorum team and our members around all the work already completed across BioPhorum on single use systems and extractables and leachables. There have been a lot of great insights and learnings from this focused day and so we’d like to extend a thank you to everyone who contributed. And special thanks is also due to our presenters, without whom our day would not have proven such a great success. Thank you   @AndreySarafanov, @ShaniLevit, @MonicaCardona, and @jamesHathcock. We’re looking forward to another great day of presentations, discussions and sharing tomorrow. Find out more about BioPhorum Advanced Therapy Medicinal Products membership here: https://lnkd.in/d9i8Edvm #AdvancedTherapies #CellTherapy #GeneTherapy #RNAtherapies #extractablesandleachables

Excitement is building as our next members-only virtual event ATMP19 is now only 1 day away! BioPhorum Advanced Therapy Medicinal Products’ three-day virtual event will run from 1-3 October focusing on Impurities & Contaminants in ATMPs. Across the three days, our audience will have the opportunity to discuss all things Extractables & Leachables, Viral Clearance, Viral Safety and Contaminants in ATMPs.  Our virtual events are an important part of the BioPhorum collaboration, as members share industry learnings, identify common challenges and strategize on ways to resolve them. There is still time to register to attend this exclusive member-only event. Please contact your Account Manager or Facilitator for details. If you are not a member of BioPhorum Advanced Therapy Medicinal Products and would like to find out more about joining our collaboration, please visit: https://lnkd.in/d9i8Edvm We hope to see you there! 

Members of BioPhorum Advanced Therapies Medicinal Products have been collaborating in discussions around the current state of Process Analytical Technologies (PAT) for Cell and Gene Therapy.    By connecting across several companies and sharing knowledge between them, the team have completed a concise summary of currently used technologies, focusing on six of the highest priority attributes identified.    BioPhorum members can download a copy of their findings here: https://lnkd.in/eE3xhx3Z   This member-only summary is a helpful resource and forms the basis for subsequent discussions relating to the future of process analytical testing in cell and gene therapy.   #PAT #CGT