BioPhorum Supply Resilience

To all our amazing members - Happy Holidays and here's to an amazing New Year in 2025... https://lnkd.in/eZKyP65x

BioPhorum Supply Resilience recently hosted a member-only 90-minute curated discussion with four major sterilization service providers on topics such as capacity landscape, future obstacles and opportunities, the long-term future of Gamma and sustainability.    The key messages from the meeting were:    1. Currently there is excess Gamma capacity available due to subdued demand, and with the ramp-up in X-ray in late 2025 (assuming no delays), there is not anticipated to be a capacity issue looming. However, this is reliant on managing demand as it returns to a new post-Covid norm (likely Q3 2025) and continuing to diversify validated modalities where possible to allow the use of Gamma or X-ray for sterilization.    2. Sustainability is a key focus, but we are still early in the X-ray journey. Going forward, the two main areas to address are the location of sites with respect to alternative or renewable electricity generation and process optimization and efficiency. There is also the offsetting of the carbon footprint in the early stages of adoption of the technology, to allow for fairer comparison versus gamma for carbon footprint.    3. Whilst Gamma irradiation will remain available where required for the foreseeable future, it is anticipated that X-ray will surpass it as the primary source of irradiation over the coming 5-10 years. The industry should plan to validate all new SKUs and a significant proportion of existing products for both modalities to capitalize on this.    To be included in any future conversations on this topic, please reach out to your BioPhorum account manager to discuss access.     If you aren’t currently a BioPhorum member, please visit www.biophorum.com to learn more, or contact us via [email protected]    #biopharma

In the aftermath of the COVID-19 pandemic, the impact of overstocking and contingency purchasing on the supply chain continues to raise some critical questions.    We know there was overstocking, but to what degree? How much is left in the system suppressing fresh demand data? How much will be usable before it expires or becomes unsuitable for onward processing?    Our Supply Partnering and Relationship Management workstream discuss these specific issues, key points for consideration and potential actions in our new publication ‘Restarting the Inbound Supply Chain: A BioPhorum Supply Partnering and Relationship Management position paper’.    Download it here: https://obi41.nl/2p9xv7r7    This paper takes a deep dive into:  - How and what should we order  - Transparency and collaboration  - Lagging vs. leading indicators  - Flexibility in material use  - Sharing risks, and  - When does capacity need to increase?    To learn more about our Supply Partnering and Relationship Management workstream, visit: https://obi41.nl/2p8dedvn BioPhorum Supply Resilience #supplychain #biophorum #biopharma

BioPhorum Supply Resilience quarterly supply survey – have your say The BioPhorum Supply Resilience cross-industry survey is now in its seventh round, building on from six quarters of previous data. Each round has gained momentum in the number of responses and has provided critical information that supports the analysis of trends and enables the evaluation of future demand on the inbound supply chain and its suppliers.   The survey data has proven invaluable to our members and our industry, supporting forecasting and helping prevent stock out, which in turn ensures patients continue to receive their treatments when needed. To share your views and help guide industry decision-making, please complete the most recent BioPhorum Supply Resilience survey here: https://lnkd.in/evt-Vq24 #BioPhorum #SupplyResilience #Biomanufacturing #BioPharma

Our Supply Resilience Leadership Team face-to-face meeting in North Carolina came to a close yesterday, ending with a great discussion on the potential for AI applications for the inbound supply chain at an industry level. In an in-depth and interactive session involving lots of green sticky dots and notations, the team assessed all possible links with our Program of Work and the full portfolio of workstreams across BioPhorum. We identified plenty of opportunities for collaboration across the 12 Phorums and will look to progress these in the coming weeks, to further strengthen Supply Resilience. The Leadership team then re-joined the Materials of Concern workstream to pick up the combined group’s top three take aways from the meeting and to share these via a paper snowball storm, which left us finishing our meeting on a real high! A key output from across the meeting is the Materials of Concern workstream team successfully furthering the development of an alert system. This can now be leveraged by the Leadership Team in the Crisis Response Team they are working on, collectively giving us impactful and tangible deliverables for the industry. After the meeting closed, attendees were invited to join a facility site tour of NC State University Biomanufacturing Training and Education Center (BTEC) which provided a great insight into the operations of this fantastic educational and training center, that develops skilled professionals for the biomanufacturing industry. Thanks to Gary Gilleskie, Ryan Barton, Ph.D. and all the team at NC State BTEC for welcoming us so warmly. Thanks also to all the BioPhorum members who participated over the three days of our meeting and especially to BARDA. Here's to a special relationship moving forward! #biopharma #biophorum #bioprocessing #SupplyResilience

BioPhorum Supply Resilience’s Leadership and Materials of Concern (MoC) teams had another productive day yesterday at our three-day meeting taking place in North Carolina.    The day started with an overview of the ongoing Regulatory Agency and Government office engagement work taking place within our MoC workstream. The Leadership team were impressed to hear that we had engaged with the FDA, the EPA, the Senate Office of Senator Dick Durbin, and the Congressional Office of Congresswoman Betty McCollum.    Our Materials of Concern workstream highlighted the value of these conversations and shared details of the information given to the agency and government officials at a key time, whilst they were drafting legislation.    Thanks to Tori Crawford, Victoria Mwanza and all the biomanufacturer and supplier members who took part.    Our Leadership team then held a separate meeting to conduct governance on our Program of Work, including the new findings from our MoC workstream. We will continue collaborating on this critical work, which will help sustain and maintain the industry's 'License to Operate'.    Fred LaPlant, Product Development Manager at 3M, then presented on how influential BioPhorum has been at changing the landscape for Single Use Systems’ adoption by the creation of the Extractables and Leachable protocol. We are pleased to learn that this protocol has become industry best practice and is now being built into the regulatory framework under the USP and ICH standards - a great demonstration of the power of our industry collaboration.    Another challenge we tackled was to look at how to develop a Crisis Response Team approach, as suggested by the Senior Sponsors of BioPhorum during the Annual BioPhorum event which took place in May. Our members collaborated on this challenge during our brainstorming sessions which has now led to a proposal which we will take back to the Senior Sponsors for support in moving this forward.    Having BARDA in the room gave this meeting a great sense of reality and understanding of the landscape and what needs to be done to connect globally. Thank you Frank Flores and Patric Klotzbuecher-Cruz for joining us.    We’re now really looking forward to seeing what Day 3 brings.  You can learn more about BioPhorum Supply Resilience here: https://lnkd.in/eJyVpzip

Day one of the BioPhorum Supply Resilience meeting in Research Triangle Park, NC included a fantastic discussion on the work being done by the Materials of Concern workstream team.   Members of the team highlighted the proactive approaches being adopted, including the alert system that has been built that triages and prioritizes new regulations that could impact materials in use by the industry. Thanks to Derek Hubley from Lonza, Jake Gibbons, CISS-EO from Genentech (Roche) and Pritam Rajkule, from Takeda for presenting on behalf of the team.   The review of the Reactive Team and the work already done by the Materials of Concern sub teams was also impressive to see. It really illustrated the need for the biomanufacturing industry to collaborate, and to communicate clearly and often with all stakeholders - both inside BioPhorum, and with all the other agencies and organizations involved. This is a vital step in ensuring that the industry speaks with one voice on the sustainability of manufacturing biotherapeutics, so that we can continue to support people and patients long-term.   It was also great to have four representatives from Biomedical Advanced Research and Development Authority (BARDA) helping us to understand the regulatory landscape in the USA more fully, and to learn about the many opportunities available for working with them and others across the Government and Regulatory landscape. Thank you all for your guidance.   To round off the day, we then enjoyed a fun, social evening with a meal and a quiz about North Carolina.   Day two will see us continuing to map out who we need to communicate with, and how to collaborate with all agencies and stakeholders effectively. The BioPhorum Supply Resilience team will then break off to work on the rest of the Program of Work that the Phorum is currently engaged in. This will include our workstreams: Alternative to Gamma, Electronic Data Exchange/Digitization of the inbound Supply Chain, Supply Partnering and Relationship Management, Supply Chain Quality Management, Risk and Business Continuity Management, Supply Chain Management for CGT and our Single Use Expert Committee and Joint Leadership Team.   #biophorum #biopharma #bioprocessing

A facility site tour - What a great way to get ready for the BioPhorum Supply Resilience meeting in North Carolina this week, bringing together our Leadership Team with our Materials of Concern workstream.    Today FUJIFILM Diosynth Biotechnologies welcomed us to their site under construction. This truly impressive site will boast 16 x 20,000L stainless steel fermenters when completed, with the first built out area of 4 x 20,000L reactors due to come online in mid-2025.    To be able to walk around the fermenter hall and all the service areas, and to talk about the project, its build approach and what it is trying to achieve was amazing.    Thank you to the Head of Site, Laurie Braxton, and all the team that led the tour and answered all our questions so expertly. Thank you also to Jeannine Rachor for helping to organize, and to site EHS and Sustainability Director, Matt Kuntz, for explaining some of the unique EHS features that help to make this site one of the safest and most sustainable sites in the world.    Next, we will begin our deep dive into 'Materials of Concern' and collaborate as biomanufacturers and suppliers with the help and support from the team at the Biomedical Advanced Research and Development Authority (BARDA).    By helping the industry to address the approach of managing our substances of very high concern from our manufacturing processes, we hope to make our industry sustainable for the future provision of biotherapeutics.    You can learn more about BioPhorum Supply Resilience here: https://lnkd.in/eJyVpzip    #biophorum #biopharma

Historically, there has been a lack of regulatory standards addressing bioreactivity testing of single-use technologies used in biomanufacturing processes.    In this absence, manufacturers have incorporated principles of GMP and adopted and adapted test practices intended for drug products in contact with plastic packaging, container closure systems, and the medical device industry. This has led to an expectation that single-use systems in biomanufacturing will meet in vivo biological reactivity testing requirements.    However, there is a growing consensus that many in vivo tests are not – and perhaps never were – appropriate to the risk assessment of single-use bioprocess equipment.   We reviewed the history and original purpose of these in vivo biocompatibility tests – including USP <88> Biological Reactivity Tests, in vivo for Class VI polymeric materials – and published our conclusions in this new paper.   It outlines the scientific rationale for moving away from USP <88> animal-based testing and toward a greater reliance on in vitro assessment, with a practical transition strategy for the single-use bioprocess industry. Thank you to our dedicated lead authors and working group members who have collaborated to drive this change,bringing together years of expert knowledge to benefit the wider industry. Monica Cardona, James Hathcock, Sade Mokuolu PhD, Ariana Gleisberg, Nicole Hunter.   For more information and contact Rebecca Tushingham, Senior Global Change Facilitator, at [email protected] Download the paper here - https://obi41.nl/9k72tk7v #biophorum #USP88 #biomanufacturing

BioPhorum is conducting a global survey to gather insights on the effectiveness of our 'Business Continuity Management in the Biologic Industry Supply Chain: A Best Practice Guide' and its associated assessment tool. You can download the guide here: https://lnkd.in/gWpYAtdJ The views of Business Continuity Management professionals globally are welcome. Your feedback is essential in helping us to understand:  How the 'Business Continuity Management in the Biologic Industry Supply Chain: A Best Practice Guide' and its associated assessment tool are being utilized across the industry  Their impact on organizational strategy and rollout Opportunities for improvement to enhance BCM practices By participating, you will therefore contribute to the continuous improvement of BCM strategies across the industry and you will gain access to valuable benchmarking data that can benefit your organization. Take the survey here: https://lnkd.in/eRgkdmS6 Your input will remain confidential and will be used solely for this research and we will ensure you are kept updated on the results of the survey.  Please share your views and help us ensure a resilient and robust supply chain for the biopharmaceutical industry. Survey closing date: EXTENDED to 30 October 2024 Thank you for your input.   #Biopharma #BusinessContinuity #SupplyChain #BCM #Resilience #ContinuousImprovement #BioPhorum