cGMP Manufacturing Of Cell And Gene Therapies For Phase I & II Clinical Trial CDMO Services

Source: CCRM

CCRM's 40,000 sq-ft PD and cGMP manufacturing facilities are staffed with 120+ scientists, engineers, operators and support functions, with plans to grow the team by late 2020 to support increasing industry demand. We have experience in manufacturing for global clinical trials, and can provide both small-scale autologous and large-scale (200 L) allogeneic batches, as well as have scalable workflows. Our team can perform complex and highly customized manufacturing runs (CAR-T, T-cell, iPSC, NK, MSC, LVV, AAV).

  • 10 cGMP suites, two dedicated to viral vectors
  • ISO Class 7/Grade B clean rooms for Phase I and II trials
  • Designed for USFDA, Health Canada, EMA compliance
  • On-site QC Testing Capabilities and QA/Audit Support
  • Located a short distance from Toronto Pearson International Airport

CCVP equipment capabilities include:

  • Hardware (USP/DSP): GE Healthcare, Miltenyi, Eppendorf, Sartorius and more
  • QC capacity: real-time PCR, multi-mode plate reader, Endosafe, flow cytometry
  • Software: MasterControl® QMS, batch record and material management systems
  • Cryo-storage for 25,000+ vials
  • Gamma cell irradiator

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