Manufacturing Materials Safety and Technology Working Group

ISCT Manufacturing Materials Safety and Technology Working Group


The Particulates Working Group aims to discuss, clarify and guide regulatory expectations surrounding manufacturing and process controls during the early-stage development of CGTs. Subsequently, the Particulates Working Group seeks to define how raw materials, manufacturing and container-closure components, and foreign particulate matter should be characterized and controlled during product development and throughout the clinical phases through the lens of form, fit, function. Special considerations will be paid to the effect of manufacturing materials on the quality and patient safety of CGTs in the era of plastics and Single-Use Systems.

Topic area of consideration include: 

  • Critical materials
  • Manufacturing materials and components
  • Primary container-closure systems
  • Extractables and Leachables
  • Container closure integrity
  • Visual inspection
  • Foreign particulate matter in the visible range
  • Sub-visible particulate matter
  • Cryopreservation from a container perspective


  • Assess the current industry gaps and concerns surrounding the characterization and control of manufacturing materials, processes, and container-closure systems intended for CGTs.
  • Define a series of best practices for characterizing manufacturing materials and container-closure systems for CGTs during early-stage product development, focusing on deep-cold and cryogenically-stored products.
  • Construct a framework for continual materials and process control that carries through late-stage development

Projects & Objectives

  • White papers: The Particulates WG currently has an opinion piece under review with ISCT Journal, Cytotherapy. Stay tuned for the publication.
  • ISCT Annual Meeting: Most recently held a roundtable at the ISCT 2023 Annual Meeting in Paris.
  • Educational Webinars: The Particulates WG are working on an open-access webinar for Q4 2023

Recent Publications

The 2024 Committee

Headshot of Sam Molina

Co -chair

Sam Molina, PhD

American Red Cross 
United States

Headshot of Sam Molina


Sean Werner, PhD

BioLife Solutions 
United States

Dominic Clarke

Cryoport Systems

Lindsay Davies
Next Cell Pharma

Manoja Eswara

Erwin Gorjup
Sarcura GMBh

Fernanda Masri

Domhnall McGowan

Mindy Miller

Terumo BCT

Atherine Opene
Thermo Fisher Scientific

Antonio Scatena
Gateway Analytical

Shahram Shahabi
Fujifilm Irvine Scientific

Andrew Snyder
Halo Labs