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Material Measurement Laboratory / Biosystems and Biomaterials Division

Biomaterials Group

Summary of Workshop on Measurement Assurance Strategies for Cell Therapy Products

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Description: There is a need for improved measurements and standards for the field of regenerative medicine and cell therapy products. A survey of 16 big pharma by Alliance for Regenerative Medicine (http://alliancerm.org/) found that "product consistency & lack of standards is possibly the single greatest challenge facing the field" of regenerative medicine [1]. Likewise, a survey by Regenerative Medicine Foundation (http://regmedfoundation.org/) found that the "lack of reference materials to benchmark measurements and validation criteria for critical assays" are the biggest roadblocks for the field [2]. Finally, a regenerative medicine roadmap identified "cell attribute measurements" as a primary need to enable reproducible manufacturing of high-quality cells [3]. In order to examine approaches for improving confidence in the measurements that are necessary for bringing cell therapy products to market, a NIST Workshop was convened.

  1. Hunsberger J, Harrysson O, Shirwaiker R, Starly B, Wysk R, Cohen P, Allickson J, Yoo J, Atala A. Manufacturing road map for tissue engineering and regenerative medicine technologies. Stem Cells Translational Medicine 2015, 4:130-135
  2. Pharma & Biotech Survey, Alliance for Regenerative Medicine, 2014
  3. Achieving Large-Scale, Cost-Effective, Reproducible Manufacturing of High-Quality Cells: A Technology Roadmap to 2025, National Cell Manufacturing Consortium, AMTech, 2016

Link to Workshop Webpage: "Strategies to Achieve Measurement Assurance for Cell Therapy Products" (includes pdfs of the agenda, speaker slides & breakout session templates)

Workshop Attendee Demographics: 94 registrants comprised of 46% industry, 41% government, 5% non-profit & 7% academic.

Workshop Report: Simon Jr CG, Lin-Gibson S, Elliott JT, Sarkar S, Plant AL (2016) Strategies for achieving measurement assurance for cell therapy products. Stem Cells Translational Medicine 5, 705-708.   https://doi.org/10.5966/sctm.2015-0269

  

 

Results of an informal survey of cell therapy stakeholders regarding key "cell therapy product measurements that need improvement". Note that cell count and viability are the most fundamental of all cell measurements, yet stakeholders felt that they were the measurements most in need of improvement. This was unexpected since these measurements are so prevalent and have existed for so long.  
 

 

Measurement Assurance Framework
There are many strategies that may be employed to improve confidence in biological measurements. Measurement assurance can be achieved by taking steps to reduce uncertainty and improve confidence in the measurement result.
 

Contributors: Carl Simon, Sheng Lin-Gibson, Anne Plant, Sumona Sarkar, John Elliott

Bioscience, Cell biology, Engineering / synthetic biology, Health, Regenerative medicine and advanced therapy, Biomanufacturing, Standards, Documentary standards, Reference materials and Standards education

Contacts

Biomaterials Group

Created May 24, 2016, Updated November 26, 2019