Single-Use Program

In this workstream, we provide a unique opportunity for single-use system (SUS) manufacturers, suppliers and end-users to collaborate and establish best practices and influence standards for agile single-use technology utilization.​ We share insights into SUS industry development and trends, driving adoption and implementation of the outputs of the workstreams which include a library of useful tools and best practices.

Identifying key industry trends in single-use technology, pain points and opportunities and supporting pathfinders to address them.

The understanding of the performance and applications of single-use systems is complicated and evolving. There has been a rapid transition away from the use of stainless steel in recent years and the use of SUS componentry has opened up the manufacturing of new modalities and lowered the barrier to entry for the production of biologics. The level of understanding around these SUS components and the materials they are made of needs to be shared across industry and between users and suppliers as more and more applications for the technology are established. The work done already in the areas need support to keep driving adoption and implementation of program deliverables, establishing best practices and influencing standards for agile single-use technology utilization.

Regulatory compliance and acceptance for the use of single-use technology

To enable realization of the refreshed vision and mission the team are developing a new five-year SUS plan while supporting the current, ongoing SUS workstream program focused on robust supply chains, validation, qualification, and application of single-use technologies across the biomanufacturing value chain. Providing guidance and expert resources for rapid response teams (PFAS/EtO/Standard review and feedback teams).

Single-Use Program deliverables

DeliverableDateDetailsDownload

Disposables: Single-use systems bag assembly leakage and defect toolkit

23 October, 2020
0.00 KB
1139 downloads

TVR: Determining testing validation and release requirements for single-use systems through risk assessment

28 September, 2020
5.29 MB
585 downloads

Change Notification: A guide to change notification packages for single-use manufacturing systems

11 September, 2020
375.42 KB
392 downloads

Disposables: Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

22 April, 2020
312.85 KB
2148 downloads

BioPhorum Extractables Data Summary BEDS Template Feb 2020

9 April, 2020
108.92 KB
203 downloads

Extractables: Single use supplier extractable reporting pack

7 April, 2020
798.51 KB
1358 downloads

Single-use user requirement (SUUR) toolkit

9 September, 2019
31.64 MB
971 downloads

Change notification: Stakeholder analysis – biomanufacturer

31 July, 2019
36.68 KB
31 downloads

Single-use, change notification: BioPhorum change notification levels and decision tree – biomanufacturer letter template

31 July, 2019
13.01 KB
56 downloads

Change notification: Stakeholder analysis – supply partner

31 July, 2019
44.79 KB
44 downloads

Single-use, change notification: BioPhorum scorecard survey

15 May, 2019
490.20 KB
88 downloads

Guide to the completion of the BioPhorum extractables data template

15 May, 2019
217.54 KB
146 downloads

BioPhorum extractables assembly family template

14 May, 2019
110.91 KB
122 downloads

BioPhorum extractables component family template

14 May, 2019
101.13 KB
302 downloads

Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

28 September, 2018
269.66 KB
308 downloads

Single-use, change notification: Guidance and implementation tool kit

26 June, 2018
211.36 KB
560 downloads

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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An industry perspective on understanding AAV capsid content variants
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An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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BioPhorum’s holistic approach to container closure integrity
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Digital Plant Maturity Model 3.0
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Inaugural BioPhorum Quality face to face – get involved
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A vision for the biopharmaceutical industry’s inbound supply chain
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BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing