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Information regarding Be The Match BioTherapies response to COVID-19

Cell Lines

The benefits of a Quality System Audit Program

Accelerate patient access to cell and gene therapies

Be The Match BioTherapies · Quality System Audits, Standardization · July 11, 2019

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What if you could shorten the time it takes to activate apheresis and cell collection sites to begin collecting starting material for your cell or gene therapy and simultaneously create efficiencies for those sites?

A standardized quality system audit (QSA) program, like the Quality System Audit Program (QSAP) offered by Be The Match BioTherapies®, helps accelerate patient access to life-saving cell and gene therapies while ensuring quality compliance at apheresis and cell collection centers.

How a QSA program benefits collection centers and therapy developers

Click on image for full size.

With QSAP, one organization audits each center one time over an established timeframe, such as every two years. Cell and gene therapy companies license the audit results from the auditing organization, alleviating the necessity for multiple companies to conduct individual, yet similar, audits at the same sites.

Therapy developers can more rapidly move sites from qualification to activation. And, collection centers can spend less time on audit activities and more time collecting high-quality starting material for therapy manufacturing and delivery to patients.

The result? Patients get access to new cell and gene therapies sooner.

Download our white paper, authored by Heather Steinmetz, MPH, Quality Assurance Manager, UCLA Health Hematologic Malignancy/Stem Cell Transplant Program; Amy Hines, RN, BSN, director, Collection Experience, Be The Match BioTherapies and Richard Smith, consultant, Be The Match BioTherapies, to explore the challenges of the current quality system audit environment and the benefits that a standard QSA program offers cell and gene therapy companies, apheresis and collection centers, and labs.

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apheresis centerCell Sourcingcell therapygene therapyquality system audit programstandardization
About the Author
Be The Match BioTherapies

Be The Match BioTherapies

Be The Match BioTherapies partners with organizations pursuing life-saving cellular therapies in every stage of development – from discovery through commercialization. Built on the foundation established over the last 30 years by the National Marrow Donor Program (NMDP)/Be The Match, we have unparalleled experience managing cellular therapies. Our cell therapy supply chain delivery for autologous or allogeneic therapies is enabled by high-touch, personalized case management and a technology platform, MatchSource®. Our experience in cell sourcing and collection allows us to provide cells consented for research, clinical or commercial use. Researchers have access to clinical trial services through our research program CIBMTR. And, we have the infrastructure in place to collect, store and analyze patient samples post-cell or gene therapy treatment at the time points required by regulatory authorities.

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