BioPhorum

Want to know more about reducing the environmental impact of drug delivery devices? Then read on!   Drug delivery devices play an increasingly important role in supporting global health and wellbeing, and the need for them is predicted to increase substantially.   However, the current model for designing, producing, distributing and end-of-life processing of drug delivery devices results in missed opportunities to embed circularity and the principles of sustainability.   Without a collective commitment to sustainable practices, there is a risk that natural resources will beirrevocably depleted and it will become impossible to reduce carbon emissions and improve circularity.   We wanted to look at the issues around the production of drug delivery devices through a lens of environmental sustainability. Our new paper provides you with: • an overview of the current state • examines the challenges and opportunities for improvement • recommends potential solutions and strategies • discusses the importance of having access to data.   It aims to establish an industry consensus on the need for a holistic, total value-chain approach to measuring the environmental impact of drug delivery devices.    You can download the full paper for free here - https://obi41.nl/c2h4582r   Next steps for the BioPhorum community are towards turning these recommendations into tangible action, and members are holding a workshop on 19 September to start that work. To find out more, or to get involved contact your BioPhorum account manager or email [email protected]   #biophorum #drugdeliverydevices #combinationproducts #sustainability

The shift towards cloud-based infrastructure in manufacturing execution systems (MES) presents a significant opportunity for organizations to leverage emerging technologies and improve their operations. However, it is essential to understand user requirements and have a two-way dialogue with vendors on how to best implement MES. You can download the paper here - https://obi41.nl/2p8caws3   Our new paper tackles this area head-on and explores areas such as: ‣ the perspectives of industry experts and their motivations for moving to the cloud ‣ the challenges of achieving a cloud-based approach ‣ the importance of customer feedback and dialogue in shaping the direction of cloud-based solutions ‣ the complexities of data security and the functional use of data and explores the critical need for a shared understanding of industry expectations to enable MES to be a full solution in the cloud.   It will help you explore all the key factors and considerations involved in implementing a truly cloud-based system.   This is the fourth in a series of papers from the MES of the Future Workstream—see also MES of the future manifesto - https://obi41.nl/msbup2am, Unlocking efficiency: a deep dive into MES integration for enhanced biopharmaceutical manufacturing - https://lnkd.in/ePkW-Fpf Navigating the data maze: a practical guide to defining priority data in MES - https://obi41.nl/2p98w9nz #biophorum #manufacturingexecutionsystems #MES #cloud

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

Environmental Monitoring Performance Qualification in new facilities: overview and application of an industry-harmonized approach 📆 Tuesday 10 September 15:00-16:30BST 📍 Online event You can register for the event here - https://obi41.nl/2xs59cf7 Can't attend? Subscribe to our YouTube channel to be notified when the webinar is available on-demand: https://obi41.nl/3ajyrc7m This webinar delves into a comprehensive overview of EMPQ for new facilities based on industry led guidance, offering insights from subject matter experts and including the following key elements: ‣ Prerequisites for EMPQ  ‣ Setting alert levels and action limits ‣ Sampling requirements and EMPQ execution (sample location selection, sampling type and number of sets of sampling) ‣ Acceptance Criteria ‣ Final Report and Area Release ‣ Post-qualification activities  Case studies of recent experiences from global biopharmaceutical manufacturers will be presented to further illustrate the elements of an EMPQ as well as highlight lessons learned, best practices and incorporation of relevant changes based on Annex 1. This webinar follows the publication of our paper Environmental Monitoring Performance Qualification in new facilities: an industry-harmonized approach, and will be a great opportunity to engage directly with the experts, exchange ideas and get specific questions answered. #biophorum #webinar

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 Supply Resilience quarterly supply survey – have your say The BioPhorum Supply Resilience cross-industry survey is now in its sixth round, building on from five quarters of previous data. Each round has gained momentum in the number of responses, and has provided critical data 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://obi41.nl/awt7b2b2 Robert Brooks Ben Kinchen #BioPhorum #SupplyResilience #Biomanufacturing #BioPharma

BioProcess international conference & exhibition September 23-26, 2024 Hynes convention center | Boston, USA BioProcess International Conference & Exhibition (BPI) in Boston is the industry’s flagship event for learning how to improve efficiencies across all phases of biopharmaceutical development and production. BioPhorum members are encouraged to attend this year’s event to access the science, technologies and contacts you need to accelerate your biologics towards commercial success. This year’s event will gather 3500+ global bioprocessing professionals, 300+ expert speakers, and 250+ exhibitors that service the entire bioprocessing lifecycle. BioPhorum is partnering with BPI and has speakers across the event. View the BioPhorum sessions on this year’s agenda at https://obi41.nl/2882fmp9

This spring, BioPhorum Sustainability released their publication ‘A case for shifting to water stewardship in the biopharma sector’.    You can download the publication here: https://lnkd.in/euH26RjP    As World Water Week progresses, here’s a reminder of what you can do at an organizational level to play your part in water stewardship.    Reliable access to clean water is critical for the biopharmaceuticals sector. There is no alternative raw material for its uses in the industry, and dependence on high-quality water from basins around the world is only growing.    It is time to rethink the biopharma industry’s approach to water. Shifting from ‘water management’ focusing on your own operations to a wider ‘water stewardship’ requires significant change management and support from your senior leaders.     To find out more about BioPhorum Sustainability’s work in this area visit:  BioPhorum Sustainability - BioPhorum    Or to join the collaboration of industry leaders driving critical change email [email protected] 

LSX World Congress USA 11-12 September Boston Find out more here - https://obi41.nl/6ek22ymx 15% discount for your network is - biophorum15 BioPhorum is delighted to partner with LSX World Congress USA. The congress represents the breadth and depth of cutting-edge research and technology driving the advances in the industry right now and in the near future.   The biotech, healthtech and medtech industry’s c-suite will be joined by the sector’s most active investors, big pharma, big medtech and health technology BD&L teams, R&D leaders, KOLs and top tier service companies who are driving the sector forward.   As convergence across health and care technology sub-sectors continues to be the major driving force in improving patient care and outcomes, the Congress continues the focus across all areas of innovation - Biotech, Medtech and Healthtech Leaders.

Environmental Monitoring Performance Qualification in new facilities: overview and application of an industry-harmonized approach 📆 Tuesday 10 September 15:00-16:30BST 📍 Online event You can register for the event here - https://obi41.nl/2xs59cf7 Can't attend? Subscribe to our YouTube channel to be notified when the webinar is available on-demand: https://lnkd.in/g3MCA8rJ This webinar delves into a comprehensive overview of EMPQ for new facilities based on industry led guidance, offering insights from subject matter experts and including the following key elements: ‣ Prerequisites for EMPQ  ‣ Setting alert levels and action limits ‣ Sampling requirements and EMPQ execution (sample location selection, sampling type and number of sets of sampling) ‣ Acceptance Criteria ‣ Final Report and Area Release ‣ Post-qualification activities Case studies of recent experiences from global biopharmaceutical manufacturers will be presented to further illustrate the elements of an EMPQ as well as highlight lessons learned, best practices and incorporation of relevant changes based on Annex 1. This webinar follows the publication of our paper Environmental Monitoring Performance Qualification in new facilities: an industry-harmonized approach, and will be a great opportunity to engage directly with the experts, exchange ideas and get specific questions answered. #biophorum #webinar