BioPhorum Drug Substance

Find out about more about the impactful activities happening in the Drug Substance Phorum. Thank you to all of our members for their continued passion, commitment and engagement that makes these publications and events possible. Reach out if you want to know more and to be part of the journey to enabling positive change within the BioPharmaceutical industry

BioPhorum Drug Substance’s fourth quarterly newsletter has just been sent to members and subscribers.     To join our mailing list and ensure you stay up to date with the latest news from the Drug Substance team, email hello@biophorum.com and we will include you on the list for our next edition.     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.   You can also catch up on Q3 Phorum showcases and register for the Q4 showcases on Life Cycle Management, Raw Materials and Continued Process Verification.    You can view a copy of the newsletter here: https://lnkd.in/e3qbcgbS 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 

On 8 and 9 October, BioPhorum Drug Substance will be hosting a virtual event focusing on post approval change. This will take place over three sessions, each one with a unique focus. Session one - 8 October: Unlocking regulatory success - Insights and innovations in LATAM We’re excited to kick off the first of three engaging sessions, focused on global harmonization for post approval changes in the biopharmaceutical industry. What to expect: · Mic McGoldrick will provide key insights into reliance from the industry’s perspective. · Mic McGoldrick, Gloria Bocardo and Flavia Firmino will host a unique workshop featuring a deep dive into the current LATAM landscape, offering attendees the chance to shape the future by addressing key barriers. · Flavia Firmino will highlight BioPhorum work with INVIMA in Colombia, supporting their recent Biologics guideline revision. · Sebastian Comellas will close out the session with an insightful case study on a recent publication from Developing Countries Vaccine Manufacturers Network (DCVMN International). 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 #biopharma #postapproval #globalharmonization #biologics #regulations #LATAM #networking #BioPhorum Caroline Meenan

Join BioPhorum Drug Substance for an exclusive showcase on Post Approval Strategy, Single-Use Systems and Human Performance Optimization Date: 26 September  Time: Session One - 09:00m CET, Session Two - 11:00 EST Location: Online (Register now using the links below) Session One: Register here - https://lnkd.in/dUMUVsmN Session Two: Register here - https://lnkd.in/dUY_9Yyx In today’s fast-paced biopharmaceutical landscape, efficiency and compliance are more critical than ever. This webinar brings together industry experts to provide actionable insights into: - Post Approval Strategy: Navigate regulatory landscapes with confidence - Single-Use Systems: Ensure a resilient supply chain and compliant qualification and application of Single Use Systems across the BioPharmaceutical value chain - Human Performance: Boost operational excellence through workforce optimization For further information about BioPhorum Drug Substance and learn how you can become part of our community visit: https://lnkd.in/ejRyz9te #drugsubstance #postapprovalchange #humanperformance #singleusesystems #connect #collaborate #accelerate

BioPhorum Drug Substance is delighted to present the new publication from the Multi Product Facility workstream ‘Changeover cleaning of empty columns and column-packing equipment—a justification for using in-process checks and controls in place of cleaning validation’.    You can download the paper here:  https://lnkd.in/e8gr8enm   This paper looks at whether time and effort spent on cleaning validation on column packing equipment is necessary, or if it can be eliminated and replaced with compliant and routine practices based on GMP, routine checks, and supportive justifications.    Thank you Michael Parks (Pfizer), Jeff Felker (Sanofi), Michael Vrijs (Incyte) and Andy Brewer (Roche/Genetech) for all your hard work and dedication in producing this important publication.  #multiproductfacility #drugsubstance #chromatography #columncleaning  Caroline Meenan Donna Hamilton BioPhorum

We’re hiring! Check out this opportunity to be part of our great team at the heart of #biopharmaceutical industry change.