The Standards Coordinating Body and Phacilitate form industry working groups to explore standards and solutions for automating cell and gene therapy manufacturing
Open call for experts from cell and gene therapy developers, CDMO's and providers of enabling technologies to participate in working groups
Gaithersburg, MD, and London, UK, 27th April 2021 | The Standards Coordinating Body (SCB), a non-profit organization established to catalyze development of standards for use by the regenerative medicine and advanced therapies industries and Phacilitate, a leading community platform for the global advanced therapies community and organizer of Advanced Therapies Week, today announced the formation of five working groups to explore standards and solutions for automating cell and gene therapy manufacturing.
The working groups are part of the Automation Special Interest Group (Automation SIG) established by Phacilitate in 2017 to discuss and propose solutions to major obstacles in automating cell and gene therapy manufacturing. The Automation SIG is actively recruiting experts from cell and gene therapy companies, CMOs and technology providers to join the following groups:
- Digitization of advanced therapies
- Vein-to-vein tracking and supply chain digitization
- Automating release for autologous products
- Modularity and flexibility in closed systems
- Aligning roadmaps for automation and technology with regulatory and process development
“At SCB, our goal is to help support development of industry standards to accelerate commercialization of safe, high-quality advanced therapies,” said Robert Shaw, Executive Director of SCB. “An essential part of this process are non-biased and impartial forums, such as these working groups, in which the issues of standardization are discussed and interested and impacted groups contribute their perspectives. The Automation SIG represents an opportunity for open and robust discussion, enabling all contributors to understand the issues, and allow development of a consensus approach.”
A digital Automation Community is also being established as a place for those with an interest in automation to connect and closely follow the progress of the working groups. Members of the larger community exchange ideas, start or respond to discussion threads, join networking events, access content and stay up-to-date on the working groups and their proceedings.
“By establishing the Automation Community, we expect to implement the important guidance from the working groups with added precision and influence much bigger change in the industry,” said Malgorzata Swida, Phacilitate’s Head of Content and Manager of the Automation SIG.
The Automation SIG and Community have secured several partnerships within the industry to support this important mission. Ben Nelson, Senior Manager of Strategic Marketing and Commercial Operations at ScaleReady remarked that “Being part of the Automation SIG allows us to collaborate with leaders across the industry to help define a framework for the future of automation. We’re excited to work side by side with therapeutic developers and other tool and technology companies towards the creation of much needed standards and novel solutions”.
About the Standards Coordinating Body
The Standards Coordinating Body (SCB) is an independent non-profit organization focused on educating the regenerative medicine and advanced therapies ecosystem on the importance of standards and bringing experts together to prioritize and catalyze standards development, harmonization and adoption. SCB helps those interested in participating in the process actively engage with the standards development community, share their expertise, have their voices heard and contribute to the standards which will affect the industry for years to come. By creating awareness of the need for standards, serving as a gateway for stakeholder engagement and facilitating access to the standards once established, SCB is playing a vital role in reducing the complexity, cost risk and time required to bring safe and effective breakthrough therapies to clinicians and patients.