Clinical Scale Manufacturing

Clinical Scale Manufacturing

The facility equipment capabilities will include the followings:

1. Hardware: Cytiva, Miltenyi Biotec, Terumo BCT, ThermoFisher Scientific and other emerging manufacturing platform etc
   
2. Quality Control / Assurance: Real-Time PCR, multi-mode plate reader, 12 parameters flow cytometer, 50 parameters flow cytometer etc

Manufacturing

1. Manufacturing Services
   1. a) Cell Manufacturing

• • • Minimally Manipulation i.e., Plasma and Red Cell Reduction, Buffy Coat Enrichment and Cell Selection
    • More Than Minimally Manipulation i.e., CTGT Product Manufacturing

1. 1. b) Cell Banking

• • • Master Cell Banking
    • Working Cell Banking

1. 1. c) Cryopreservation and Storage
2. Manufacturing Support
   1. a) On-Site QC Testing Capability

• • • Rapid Release Test i.e., Mycoplasma, RCL Assay etc
    • Potency Assay i.e., Cytokine Release Assay etc

1. 1. b) On-Site QA/Audit Support
   2. Cold Chain Management Using Validated In-House as well as External Logistics Provider