BioPhorum

In the rapidly evolving biopharma industry, the need for harmonized and patient-centric approaches to setting and justifying commercial specifications is paramount. BioPhorum’s latest publications outlined below address these critical needs by providing comprehensive frameworks and guidelines that streamline processes and enhance regulatory interactions. Harmonized approaches for setting and justifying commercial specifications of biological drugs  In the ever-evolving landscape of biopharmaceuticals, the need for consistent and patient-centric specifications has never been more critical. However, the approaches to setting and justifying specifications vary widely across industry. This inconsistency, non-harmonized requirements, and feedback from health authorities around the world lead to significant frustrations and an increased workload that does not always add value for patients. As industry moves toward more global, data-driven submissions and reviews, there is a clear need for standardized strategies that can be universally accepted. Our new paper addresses this pressing issue head-on. View here - https://obi41.nl/3ubpjmmr #biophorum #specifications #CMC #controlstrategy #acceleratedprograms

BioPhorum Global Relationship Director Alan Ross will be at E&L Europe 2024. BioPhorum (formerly BPOG) provides a unique collaboration for manufacturers, suppliers and end-users to collaborate and establish best practices and influence standards. Recent publications such as Guidance for risk evaluation of X-ray irradiation of single-use systems - https://lnkd.in/ep9Cma7k the importance of manufacturers and suppliers working together to support industry. To find out how you can be part of this reach out to Alan Ross or email [email protected] Louisa Mitchell BioPhorum Supply Resilience BioPhorum Drug Substance

BioPhorum is excited that Frances Sexton will be chairing the E&L case studies and single-use session plus the regulation session at the forthcoming Extractables and Leachables Europe 2024 on 5 November in Vienna, Austria.   BioPhorum (formerly BPOG) provides a unique opportunity for manufacturers, suppliers and end-users to collaborate and establish best practices and influence standards for agile single-use technology utilization. We share insights into SUS industry development and trends, driving adoption and implementation of the outputs of the workstreams which include a library of useful tools - https://obi41.nl/273ze44h and best practices. Our industry leading publication The BioPhorum (BPOG) extractables protocol can be downloaded here - https://obi41.nl/ydmrnfts To find out more about BioPhorum contact [email protected] Louisa Mitchell, BioPhorum Supply Resilience, BioPhorum Drug Substance

Today sees the end of what has been a fantastic tri-Phorum event in Copenhagen, Denmark, with representatives of 37 member companies attending.    BioPhorum Technology Strategy members explored opportunities for collaboration and, using case studies and by sharing best practice, identified optimal routes to a sustainable future in drug product manufacturing.    BioPhorum Fill Finish members explored the progressive role of advanced technologies in aseptic processing and mapped out the future of their collaboration through case studies and interactive workshops.    BioPhorum Sustainability members held interactive sessions on their Circularity Maturity Model and Plastics workstreams, in addition to member case studies. They discussed their vision and how collaborating plays an important part in ensuring companies’ strategic sustainability objectives are met.    We’d like to thank all participants and speakers for their case studies, contributions and conversations in making this such a successful initiative.     And a special thank you to our Novo Nordisk representatives for their hosting of an incredible site tour at the Hillerød facility.

PAT Monitoring and Control Roadmap Webinar Date - 21 November Time - 15:00 - 16:00 GMT This webinar will discuss The BioPhorum Process Analytic Technology Monitoring and Control (PAT MC) roadmap for developing, validating, implementing process analytic technology (PAT), and navigating the path towards good manufacturing practice (GMP) application. The roadmap, out now - https://obi41.nl/2p8ab2n6 aims to overcome the current organizational and regulatory challenges facing the biomanufacturing industry. It includes topics such as building a business case, PAT technology development, deployment and engagement, qualification, validation, transfer, lifecycle management and the regulatory landscape. The roadmap will empower organizations with the best practices to enable PAT, leading to better process understanding and control, improved product quality, and potentially improved productivity. Register for the webinar here - https://obi41.nl/bd5zncwd Can't attend? Subscribe to our YouTube channel to be notified when the webinar is available on-demand: https://lnkd.in/g3MCA8rJ #biophorum #biopharma #webinar

BioPhorum members and biopharmaceutical industry leaders are invited to join BioPhorum Supply Chain to Patient on 13 November at 15:00 - 16:00 BST/10:00 - 11:00 EST for the follow-up session on ‘Removing emotional bias: Optimizing supply chain decision making with data’. The first roundtable welcomed 26 senior leaders in supply chain management from 18 global industry organizations and initiated interesting discussions around some key themes that the next session will explore further.   Attendees of this event will have the opportunity to engage in discussions on:    ‣ The role of data in decision-making  ‣ Balancing data with intuition  ‣ Overcoming resistance to data-driven decisions    This is a must-attend for senior leaders and experts in supply chain management, digitalization, and innovation.  Register now: https://obi41.nl/2p8h88u8 Can't attend? Subscribe to our YouTube channel to be notified when the webinar is available on-demand: https://lnkd.in/g3MCA8rJ   For further information on BioPhorum Supply Chain to Patient visit:  https://obi41.nl/bdfustyy    #SupplyChain #BioPhorum #DataDriven #VirtualEvent #IndustryLeaders #Innovation

It’s great to see representatives from 37 member companies coming together in Copenhagen, Denmark this week where BioPhorum Fill Finish, BioPhorum Sustainability and BioPhorum Technology Strategy will collaborate to identify optimal routes to a sustainable future in drug product manufacturing. Attendees have also been invited to visit Novo Nordisk’s Hillerød site as part of their leadership team meeting.    We’d like to extend our thanks to all the many participants, speakers and contributors for their help in building what we’re sure will be a fantastic occasion. #biophorum #biopharma

Have you subscribed to our YouTube channel?   You can do so by clicking here: https://obi41.nl/yckmfd3n   Learn visually as experts from across the industry walk you through our most downloaded publications. By subscribing, you will be notified as soon as new webinars or BioPhorum videos are ready to watch.   Our channel has been set up in a way that is easy for you to navigate. Our webinars are set up with chapters to help easy navigation through sections, and each video has been added to a Phorum playlist, allowing you to browse through the topics you are most interested in.    Subscribe today to make sure you are up-to-date with the most recent content from BioPhorum, across all our channels.  https://obi41.nl/yckmfd3n

BioPhorum is excited to present work for two Phorums at PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024, BioPhorum Drug Delivery and BioPhorum Sustainability will present on the issues around the production of drug delivery devices through a lens of environmental sustainability. To read our paper on this download here: https://obi41.nl/c2h4582r Additionally. Dr Soroosh Bagheriasl will be presenting the work BioPhorum Drug Delivery are exploring on drug device co-development challenges.  To find out more about BioPhorum contact [email protected]   BioPhorum BioPhorum Sustainability Lucy Shering Soroosh Bagheriasl , PhD

Process analytic technology (PAT) monitoring and control is rapidly progressing as instruments shrink in size, have faster signal acquisition time, analyzers account for more variables, and modeling becomes more machine-learning based. However, each organization will have its own challenges around data management, organizational structure, internal support staff/resources, and funding – so it can be difficult for pharmaceutical and biopharmaceutical companies to understand the ideal path to implement PAT. This is why we have published this roadmap, which can be used for developing, validating, implementing PAT, and navigating the path toward good manufacturing practice application. Adopting PAT is a collective journey that necessitates a broad spectrum of expertise within an organization – but requires careful planning, cross-functional collaboration, and a clear business case to ensure its successful implementation. Our paper will help you do this, and more. Download here - https://obi41.nl/2p8ab2n6 #biophorum #pat #processanalytictechnology