Manufacturing Materials Safety and Technology Working Group

Charter

The Manufacturing Materials Safety and Technology (MMST) Working Group aims to discuss, clarify and guide regulatory expectations surrounding manufacturing and process controls during the early-stage development of CGTs. Subsequently, the MMST 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.

The MMST Working Group Aims to: 

• 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 and commercialization.
  
  

Recent Publications

• Curated Roundtable at ISCT Annual Meeting 2024 in Vancouver:
  Let's Talk Particulates: Working Towards Best Practices 
  
  
• Article published in the October 2024 issue of Telegraft, ISCT’s Monthly Newsletter:
  Committee Spotlight: ISCT Manufacturing Materials Safety and Technology (MMST) Working Group - Process Development and Manufacturing Committee
  
  
• Publications in Cytotherapy, the official Journal of ISCT:
  
  • Particulates are everywhere, but are they harmful in cell and gene therapies? (2022)
  • Particulates in CGT guidance survey results – an ISCT process development & manufacturing committee perspective on cell and gene therapy industry knowledge awareness (2024)
    
    

The 2024 Committee

Dominic Clarke
Cryoport Systems

Lindsay Davies
Next Cell Pharma

Chris Harrison
Cellino Biotech

Renee Harte
LumaCyte

Tim Largen
Applied Stemcell

Kelly McDonald
CGT Catapult

Mindy Miller
Terumo BCT

Sam Molina
American Red Cross

Atherine Opene
Thermo Fisher Scientific

Sreethu Sankar
Proteintech Inc. 

Maximilian Schlebusch
Miltenyi Biotec

Andrew Snyder
Halo Labs

Dave Stull
Cook Myosite

Rogetio Zamilpa
BioBridge Global