BioPhorum Drug Substance

BioPhorum Drug Substance's exclusive showcase on Life Cycle Management, Raw Materials and Continued Process Verification was held on the 09 & 10 December.  If you weren’t able to attend, we now have this available to watch on demand via our YouTube channel here: Phorum Drug Substance introduces workstreams: Life Cycle Management, Raw Materials and Continued Process Verification - BioPhorum In today’s fast-paced biopharmaceutical landscape, efficiency and compliance are more critical than ever. This webinar showcased the work being done to address current industry challenges in the following areas:  - Life Cycle Management: How defining functional equivalence for equipment can support simplification of validation practices.  - Raw Materials: Shaping the program for the next 5-years to harmonize the raw materials supply chain from suppliers to biomanufacturers.  - Continued Process Verification: This community of practice meets several times a year to discuss hot topics relating to CPV and to share learnings on the extensive back catalogue of BioPhorum best practice guides on this topic. If you’re not currently a BioPhorum member, you can learn more about BioPhorum Drug Substance here: https://lnkd.in/ejRyz9te or hello@biophorum.com   You can also subscribe to our YouTube channel for updates on other BioPhorum initiatives here: https://lnkd.in/g3MCA8rJ  #drugsubstance #connect #collaborate #accelerate

BioPhorum Drug Substance are hosting a showcase on our Life Cycle Management, Raw Materials and Continued Process Verification workstreams. The showcases will be held on 09 and 10 December. Session One - 09 December, 16:00 GMT Session Two - 10 December, 08:00 GMT Location - Online You can register using the links below. Session one - Register here: https://lnkd.in/ebSg5gDJ Session two - Register here: https://lnkd.in/eZiDNPMM In today’s biopharmaceutical landscape, efficiency and compliance are more critical than ever. This showcase event brings together industry experts to provide actionable insights into: - Life Cycle Management: How defining functional equivalence for equipment can support simplification of validation practices. - Raw Materials: Shaping the program for the next 5-years to harmonize the raw materials supply chain from suppliers to biomanufacturers. - Continued Process Verification: This community of practice meets several times a year to discuss hot topics relating to CPV and to share learnings on the extensive back catalogue of BioPhorum best practice guides on this topic. For further information about BioPhorum Drug Substance and to learn how you can become part of our community visit: https://lnkd.in/ejRyz9te #drugsubstance #connect #collaborate #accelerate

Today marks the end of what has been a fantastic joint event with BioPhorum Development Group in Munich, Germany with a total of 51 representatives from 27 BioPhorum member companies in attendance.    During our collaborative workshop, we explored several key areas that enable development for commercial success, such as:  - Aligning on aspirations for process and operational maturity  - Exploring trends in Health Authority feedback  - Identifying opportunities to further process understanding, and  - Sharing best practices to streamline transfers.    We extend our gratitude to our presenters Shawn Lawrence & John Mattila (Regeneron), Guido Kremer-van der Kamp (Merck) and Derek Lonergan (Jazz Pharmaceuticals) for sharing their valuable insights.    The theme for our final day's discussions, ‘Focus on the future’ featured case studies from Annemette Gregersen (Novo Nordisk) on ‘Uncovering the hidden challenges behind the brilliant idea’. This presentation provided important insights into the Process Analytical Technology (PAT) implementation and learnings from Albin Simoni (Merck) on ‘Implementation of the BioPhorum X-ray Sterilization Risk Assessment’ across their network. This set the stage for our concluding sessions, which centred on future collaboration opportunities. Thank you to both presenters for sharing such engaging and thought provoking case studies.   We evaluated new ideas using the newly developed Drug Substance operational maturity model to ensure the correct focus for workstreams to drive value realization and longer-term industry transformation. Once finalized, this tool will enable all members to benchmark their current maturity levels and establish direction and future operational ambitions at both individual and industry levels.    A huge thank you to all our members for making this event so informative and engaging.    For further information about BioPhorum Drug Substance and to learn how you can become part of our community visit:   https://lnkd.in/ejRyz9te   Or you can contact hello@biophorum.com Catherine Wyatt, Nicola Powell, Caroline Meenan, Louisa Mitchell, Olivia Paisley, Paul Osborne, Tim Corbidge, Sam Johnson & Sean Collins  

The BioPhorum Drug Substance team would like express our sincere gratitude to the Boehringer Ingelheim team for hosting us at their Biberach site yesterday. The tours of the fantastic facilities at the site provided numerous opportunities for engaging discussions. A special thanks to Beatrix Metzner, Karin Kieser, Markus Mortsch, Jan Visser, Patrick Garidel, Peter Happersberger, Susanne MÜLLER, Jasmine Kaiser and Stefan Minning for making this event possible!

All of us at BioPhorum Drug Substance are looking forward to meeting with industry leaders during our member only face-to-face meeting in Munich, Germany next week.      The event will bring BioPhorum Drug Substance together with BioPhorum Development Group focusing on the theme of ‘development for commercial success’. It will create a unique opportunity for industry leaders to connect and explore opportunities for collaboration.    BioPhorum Drug Substance’s leadership team will take this opportunity to use member case study presentations and interactive workshops to advance excellence in bulk drug substance manufacturing and testing.     Not yet registered? If you are a member, you can do so by contacting your Account Manager.     If you’re not currently a BioPhorum member, you can learn more about BioPhorum Drug Substance here: https://lnkd.in/ejRyz9te or contact hello@biophorum.com

BioPhorum Drug Substance has issued its fourth quarterly newsletter to members and subscribers.     To join our mailing list and ensure you stay up to date with our latest news, email hello@biophorum.com.    Our latest newsletter includes features on: • Our exclusive Post Approval Strategies virtual event  • Our upcoming leadership F2F in Munich   • Three recent industry events where BioPhorum members presented, covering single use technologies, Multi Product Facility and Post Approval Strategy  • Our latest Phorum publications on 'Streamlining environmental monitoring' and 'Changeover cleaning of empty columns and column-packing equipment'.   Subscribers are also invited to watch our recent workstream showcases on demand, to learn what we’re focusing on within our Phorum, and to register for forthcoming showcases focusing on Life Cycle Management, Raw Materials and Continued Process Verification.   To subscribe to our newsletter, email hello@biophorum.com  Catherine Wyatt, Nicola Powell, Caroline Meenan, Louisa Mitchell, Olivia Paisley, Paul Osborne, Sam Johnson & Sean Collins #drugsubstance #postapprovalstrategies #multiproductfacility #closedsystems #microbialcontrol #cellbanks #singleusesystems #connect #collaborate #accelerate

BioPhorum Drug Substance recently held its latest workstream showcase webinar, highlighting its Post Approval Strategy, Single-Use Systems and Human Performance workstreams.  We are pleased to announce that the webinar is now available on-demand via our website: https://lnkd.in/eUNMnQV6  In today’s fast-paced biopharmaceutical landscape, efficiency and compliance are more critical than ever. This webinar shows the work being done in three of our workstreams to address current industry challenges in the following areas:  - Navigating regulatory landscapes with confidence  - Ensuring a resilient supply chain and compliant qualification and application of Single Use Systems across the biopharmaceutical value chain  - Boosting operational excellence through workforce optimization    For further information about BioPhorum Drug Substance, its workstreams and to learn how you can become part of our community, you can visit:  https://lnkd.in/ejRyz9te  You can subscribe to our YouTube channel to be notified when webinars become available on-demand here: https://lnkd.in/g3MCA8rJ   #drugsubstance #postapprovalchange #humanperformance #singleusesystems #connect #collaborate #accelerate

BioPhorum Drug Substance are pleased to announce the first publication from the #Annex1 applied in DS workstream:  ‘Streamlining environmental monitoring in low bioburden drug substance production: industry interpretation of Annex 1’     You can download the paper here: https://lnkd.in/eZApT8jS The paper provides guidance on how to interpret and apply the environmental monitoring principles of Annex 1, to the low bioburden drug substance manufacturing industry.     While Annex 1 primarily focuses on sterile products, certain principles, particularly regarding contamination control, are relevant to low-bioburden drug substance manufacturing.    The paper systematically examines each paragraph of Annex 1's environmental monitoring section, providing a consensus interpretation of its applicability to low-bioburden Drug Substance facilities. It advocates for a risk-based approach to environmental monitoring, explaining the importance of tailored risk assessments and a comprehensive contamination control strategy to ensure appropriate controls for each specific product, process, and site.     This paper aims to enhance clarity for the low-bioburden drug substance manufacturing industry and provide a risk-based roadmap for ensuring consistency in environmental monitoring practices across the industry.     Thanks to Sallyann Connor, Taylor Patzwahl, Cathrine Friberg, Paul Osborne, Aateka S., Donna Foti, Maria Paola Baini, Paula Doolan, Audrey Meade, Andrew Digga for all your hard work and dedication in producing this important publication.    #connect #collaborate #accelerate #Annex1 #DrugSubstance 

Join BioPhorum for the third and final session of their exclusive virtual event focusing on Post Approval Change!    Date: 9 October    Session three:  Life cycle management of raw materials and future vision for Post Approval Strategy    In this session, we will begin with an insightful BioPhorum member case study that explores the Quality by Design (QbD) approach to registering raw materials using critical material attributes, and how to overcome potential challenges for successful implementation.    Next, we'll engage in a workshop to delve deeper into the topic, focusing on:    Identifying common challenges in implementing QbD for raw materials  Discussing tools and processes that can be utilized  Understanding the key influencers within and outside your organization needed for successful implementation    The event will conclude with an aspirational presentation of BioPhorum's insights into future tools for Post Approval Changes.    Don’t miss this opportunity to connect with industry experts and drive forward the conversation on harmonization and innovation!      Register now: https://lnkd.in/eJjGKEUW Olivia Paisley Tim Corbidge Frances Sexton Elisabeth Lafay Isabelle LEQUEUX #biopharma #postapproval #globalharmonization #biologics #regulations #rawmaterials #networking #BioPhorum

BioPhorum Drug Substance are hosting three exclusive sessions for our virtual event focusing on Post Approval Change.    In case you missed our last post, you can read more information on the first session and register for it here: https://lnkd.in/esk3qdTh   Session two – 8 October: The journey from harmonization to reliance.    Are you curious to learn more about the transition from harmonization to reliance and how it is reshaping the regulatory landscape?    Session two will host an in-depth session featuring case studies from both industry and regulatory experts on the implementation of reliance. In this session, we will explore the prerequisites, hurdles, and opportunities that come with this evolving approach.    BioPhorum Regulatory CMC Phorum Director, Alison Robinson, will wrap up the session with an interactive panel discussion, giving attendees the chance to ask questions, gain valuable insights, and engage in meaningful conversations about the future of regulation.    Register here: https://lnkd.in/eJjGKEUW   #biopharma #postapproval #globalharmonization #biologics #regulations #LATAM #networking #BioPhorum