This paper summarizes the industry position and aims to start a strategic discussion on this situation. It will help ensure we have a common language and understanding across industry. Looking ahead, we will emphasize shared learning, best practices, and retrospective investigations to improve long-range planning processes
This paper proposes that shared and electronic data exchange (EDE) is a cornerstone of collaboration and innovation in the supply chain. The paper aims to demystify EDE, set out its importance for supply chain effectiveness, capture its benefits and help people understand the practical enablers.
This paper provides an overview of the current and near-future bioprocess supply situation and trends. This research provides insights into how the industry has adjusted as the Pandemic begins to abate.
This paper provides an introduction and a high-level view of on time in full (OTIF) so that when we use the acronym, we know how it is calculated and are all using it in the same way. It examines detail on the components of ‘Actual orders delivered’ and ‘Expected orders to be delivered’ and talks about the information included, actions to take and gives tips on how to best use each component.Â
These tools support sharing the optimal high-level steps to simplify a process and invite people into the discussion using a common language. The optimal process outlines the essential process steps and for each one lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). The RACI supports people to understand where accountabilities and responsibilities lie.
Suite of deliverables to support the forecast and demand planning process and complement the FDP Toolkit. They include an optimal process, RACI and template. These areas are where there is potential for the greatest benefit and will create value for industry when used correctly.
A benchmark survey which sets out to establish the baseline for electronic data exchange across participating members, to understand: How suppliers and biomanufacturers were working with EDE for raw materials across their inbound supply chain, whether they were using the ASTM standard and, if so, its application and value to their company and to provide Insights for improving EDE across the sector. The results cover utilization, prioritization, ASTM E3077-17 standard utilization and the benefits and challenges in implementing it, EDE maturity, benefits and challenges for EDE in the inbound supply chain, EDE accelerator and other conclusions.
A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.
The BioPhorum Alternative to Gamma Sterilization workstream is focused, in partnership with the Bio-Process Systems Alliance, on raising awareness of the need for sterilization alternatives for single-use systems. As part of this work the team discovered a need to understand some of the first principles. This paper is to provide a lay person’s introduction to the need for change, the basic physics involved and a high-level comparison between x-ray and gamma
Over the course of 14 months, eight site audits were carried out on BioPhorum’s Supply Partner supplier member company sites and these were made available for industry to license via the Rx-360 website. The audits were conducted through the Rx-360 Joint Audit Program and its audit partner BSI. This report details the methodology of the approach, the feedback and the findings of all the stakeholder groups involved and the reviewer panel involved in the pilot program.
Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.
We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C>-specific validation issues, as well as working toward resolving the current challenges to commercializing C> products. Discover more and learn about the outputs here.
The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.
Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives
Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.
Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.
Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges. To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here.Â
IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum.Â
The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation.Â
BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, Filing and Review, Interactions with Health Authorities, and Harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.
The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.
BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:
There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.
The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.
BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.
With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.
This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.
The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.
Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.
AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.
Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.
