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Johns Hopkins Bloomberg School of Public HealthCAAT
 

Microphysiological Systems and Systems Toxicology

Lena Smirnova

Coordinator: Lena Smirnova (lsmirno1@jhu.edu)

Call for Expression of Interest:
P4M—Public Private Partnership for Performance Standards for Microphysiological Systems

Organo-typic cultures with elements of organ architecture and functionality are flourishing, increasingly moving even to multi-organ systems.They promise to boost the relevance of in vitro work, fueled also by the increasing availability of high quality human cells due to stem cell technologies. CAAT has been part and actively promoted these developments. In various stakeholder discussions, we perceived the need to complement the technical developments with quality assurance aspects. Our ongoing efforts toward Good Cell Culture Practice (GCCP), in vitro reporting standards and in vitro risk-of-bias assessments already go in this direction.

As a next step, we would like to invite all stakeholders to join us starting a discussion about performance standards for microphysiological systems (MPS). This will encompass questions like:

  • What makes a cell culture an MPS? 
  • What is a good MPS, e.g. fit-for-purpose, reproducibility, relevance, validity?
  • How does an MPS need to be documented and reported? 
  • How can a lab show proficiency in testing with an MPS? 
  • What quality assurance and management need to be in place? 

This call for expression of interest wants to identify possible partners from academia, regulatory agencies, industry (users and technology providers), and others (e.g., NGOs). You are invited to contact us at caat@jhu.edu. Letter of motivation and referrals to relevant activities in this area you are part or aware of are most welcome. We will start organizing the dialogue with the exact form depending on the responses received.

Become part of an exciting process helping to revamp the relevance of in vitro work!