This paper provides a commentary on the analytical methods used for the release and/or characterization of full, partially filled, and empty capsids in various process development step and clarifies which analytical methods are amenable to GMP validation for product release in late-stage clinical trials and commercialization of gene therapy products.
As a first step toward defining an industry-accepted ontology, the BioPhorum Technology Strategy Big Data to Smart Data workstream has reviewed best practices for ontology development across industries, adapted them to the biomanufacturing
space and then carried out an initial proof-of-concept (PoC) implementation of ontology-enabled analysis. The results demonstrate how implementing better data management as part of a digital transformation can create compounding value over time.
Ethylene oxide (EtO) is one of the most widely used sterilization methodologies in the biopharmaceutical industry. However, the US Environment Protection Agency (EPA) has issued proposals for a five-year timeline for cycle redesign and compliance to reduce EtO used in existing products to ≤500mg/L and two years for new products to market. The biopharmaceutical industry understands the rationale for the proposed changes but thinks the...
This BioPhorum approach aims to define the polymer-based transfection reagent release testing needed for cell and gene therapy processes.
The BioPhorum Closed Systems in CNC space team have collated a terms relevant to closed systems and closed processing derived from multiple sources, including the FDA, EU EudraLex Volume 4, various WHO documents, ICH Documentation, ISPE documents and ASME.
This document outlines a general strategy for drug substance and/or drug product manufacturing processes expected to undergo process performance qualification with considerations unique to gene therapy. It addresses the specific requirements of the gene therapy industry, as general validation templates from the biologics industry may not be entirely applicable.
This chapter focuses on current regulations and guidelines mentioning and supporting the implementation of closed systems as a contamination control measure in the product protection strategy.
This paper sets out the rationale and approach to conduct a ‘tabletop exercise’ (TTE) that explores the readiness of operational technology (OT) and information technology (IT) support organizations to handle a
cybersecurity incident impacting a manufacturing plant. It describes the value of a lessons-learned exercise after the event to make improvements to processes and ways of working.
This response to Annex XV restriction report proposal for a restriction on per- and polyfluoroalkyl substances from the European Chemicals Agency (ECHA) has been submitted by MediPhorum, a global medical technology collaboration within BioPhorum comprising major manufacturers and suppliers of medical technologies from the biopharma sector.
This BioPhorum document focuses on cybersecurity vulnerability management, considering the challenge of exploitable code and protocol weaknesses, and how to address these. We consider why the threat landscape is changing and offer some ideas about its effective
management.
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.
