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BPSA Publishes Two New Papers Highlighting the Role of Single-Use Technologies in Cell & Gene Therapy and Continuous Bioprocessing

The Bio-Process Systems Alliance (BPSA) is pleased to announce the publication of two new technical papers focused on advancing the implementation of single-use technologies across biopharmaceutical manufacturing. The new resources address manufacturing bottlenecks in cell and gene therapy production and the growing adoption of continuous bioprocessing.

The first paper, Navigating Cell and Gene Therapy Manufacturing Bottlenecks, examines common constraints that impact the scalability and reliability of cell and gene therapy manufacturing. The paper highlights how single-use technologies address operational bottlenecks and support flexible and efficient manufacturing strategies in this rapidly evolving sector.

The second paper, Continuous Bioprocessing with Single-Use Technologies, explores how single-use systems support the transition from traditional batch processing to continuous manufacturing. This paper provides a practical overview of key considerations, challenges, and opportunities for integrating single-use technologies into continuous operations.

“These two papers focus on areas that are at the center of innovation and growth across bioprocessing,” said BPSA Chair, Mark Petrich, PhD, of Krystal Biotech. “Single-use technologies continue to play a critical role both in addressing the unique challenges of cell and gene therapy manufacturing and in enabling more flexible approaches to continuous bioprocessing. These BPSA papers provide valuable insights for single-use suppliers and end-users alike.”

“I would like to thank the BPSA Advanced Therapies Committee, co-chaired by Brendan Lucey of Kivi Bio LLC and Todd Pangburn, PhD of Dupont, and the BPSA Continuous Bioprocessing Committee, co-chaired by David Chau, PhD of Thermo Fisher Scientific and Davinder Chawla, PhD, of Sanofi, for their dedication and contributions.”

The papers are now available for download:

Navigating Cell and Gene Therapy Manufacturing Bottlenecks – Download
Continuous Bioprocessing with Single-Use Technologies – Download

Visit BPSA’s resource library for additional information.

Special thanks to BPSA sustaining sponsors: AdvantaPure, Burkert Fluid Control Systems, Cytiva, CPC Biotech, Entegris, MilliporeSigma, PendoTECH, Renolit Healthcare, Saint-Gobain Life Sciences, Sartorius and Solvias for making these resources possible.

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Updated Single-Use User Requirements (SUUR) Toolkit Published by BioPhorum & BPSA

Single-use technologies have become integral to modern biopharmaceutical manufacturing, supporting faster, more flexible production in an increasingly complex regulatory landscape. As adoption accelerates, the need for clear, consistent communication between end-users and suppliers has never been more critical. Yet effectively communicating single-use system (SUS) requirements remains a challenge across the industry, often revealing gaps in expectations between end-users and suppliers. 

We wanted to equip the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities in accordance with industry standards. BioPhorum, in collaboration with the BPSA, has therefore published an updated edition of the Single-Use User Requirements (SUUR) Toolkit – Implementation & Use. This update reflects both current regulatory expectations and the practical experience gained since its original release in 2019. 

The Toolkit is a collection of standard templates to support SUS design and qualification, facilitating right-first-time implementation. It includes a user requirements template, supply chain memo template and a supporting ‘how to’ and implementation guide. It equips the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities when building SUS for an end-user application. 

SUURs allow end-users to communicate process/application details and single-use requirements to suppliers, and allow suppliers to affirm or describe their capabilities to meet these requirements. The Toolkit uses consistent terminology in a logical structure of simple, categorized requirements. 

The supply chain memo template is an additional, optional template that allows end-users to communicate requests for supply-chain-related information at the component level to suppliers, providing transparency of the supply chain for a SUS and enabling understanding and management of risk.  

So what is new and why does it matter? 

  • The updated guidance is now aligned with ASTM E3051-25, EU GMP Annex 1 and BPSA Quality Test Matrices 
  • It contains practical, step-by-step recommendations for implementing SUURs across organizations and supply chains 
  • It has an expanded focus on cross-functional engagement between manufacturing, quality, engineering, sourcing and suppliers 
  • It contains clear guidance on how to use the SUUR template and optional supply chain memo to improve transparency, reduce rework and accelerate ‘right first time’ execution 
  • It includes real-world considerations for rollout, governance and change management. 

The SUUR Toolkit adds significant value to the industry by establishing a common language and a structured approach for defining requirements and confirming supplier capabilities. This reduces misalignment, mitigates risk and supports faster, more robust implementations of SUS. 

For end-users, the Toolkit minimizes non-conformances and regulatory risks caused by gaps in expectations with suppliers. It also reduces implementation timelines for new designs, minimizes supply disruptions, and facilitates second sourcing by comparing supplier responses like-for-like. 

For suppliers, the Toolkit deepens the understanding of customer application and requirements up front, ensuring that designs are fit for use. It also provides consistency in the content and format of user requirements, reducing the time and resources required to respond by preparing standard responses in advance. 

Developed collaboratively by end-users and suppliers, this update reinforces SUURs as a foundational best practice for designing, qualifying and implementing SUS in today’s regulatory and supply-constrained environment, and will help drive consistency, transparency and confidence across SUS design and supply. 

Click here to download the new SingleUse User Requirements (SUUR) Toolkit – Implementation & Use