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 document communicates a strategic framework for solving technical problems relating to managing raw materials in the biopharmaceutical industry and encourages biopharmaceutical end-users and suppliers to work together to address specific raw material and end-user process needs. It highlights the importance of implementing industry solutions and sign-posts a range BioPhorum raw materials publications. These establish standard definitions, a common understanding of raw material requirements, and the importance of regulatory, quality, and supply chain links.
Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.
A comprehensive benchmarking survey aimed at collating data on the technical practices involved in therapeutic protein production and evaluation of if/how this has changed in response to the COVID-19 pandemic.
The biopharmaceutical manufacturing industry inbound supply chain strategic framework identifies the key five strategic objectives that will help drive operational excellence and improvements to solve some of the most important inbound supply chain issues for the industry over the next 2–5-years.
This paper provides an overview of points to consider and good practices relating to the most challenging areas identified following an industry benchmark on the serialization of sellable units. The purpose of this benchmark was to identify common industry challenges with serialization and to broaden the knowledge of good practice, industry capabilities and to identify the quickest route to implementation and compliance with global serialization requirements. The paper also seeks to encourage dialogue between industry, regulatory agencies, and track and trace system providers, by adding the unique perspective of secondary packaging customer, summarized after several years of using such serialization systems
This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.
Drawing on their real-world experiences, a group of experts drawn from 28 BioPhorum member companies has provided guidance on the detailed working methods that support a successful remote inspection or audit; for example, how to manage information flows between the inspectors and the site subject matter experts’ team. With the impact of Covid-19 likely to be seen for the foreseeable future, virtual inspections may be required for some time. This guidance will help all stakeholders prepare and to avoid the potential problems of remote inspections and audits.
The checklist is a best practice checklist to define the recommended minimum required steps to generate a useful forecast. It is for companies moving towards mature demand forecasting practices, and biomanufacturers and suppliers with regular demand forecasting meetings. It should be used each time a new forecast is generated to ensure the key steps are carried out. The communications pack explains the recommended forecast and demand planning cycle of events, i.e. when you should sit down and talk, what you should talk about, what should be in the discussions, etc. This will help guide and structure the regular meetings between biomanufacturers and critical suppliers. Having a comprehensive framework for those meetings is essential, especially when discussing key materials. It includes everything from the minimum required agenda items and an action log template, to a forecast confidence ‘traffic light’ indicator and ‘hints and tips’ to get the most out of the pack.
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.
