Cell Therapy
Manufacturing
We work with you to translate your processes into cGMP manufacturing
cGMP lot production
Small or large scale production of cell therapy products produced with cGMP compliant, validated processes.
Lot release testing
PCM has internal lot release testing capabilities and can manage outsourcing for any required assay development or third-party testing.
cGMP Storage
cGMP compliant storage of raw materials and intermediary/final product.
Multiple storage conditions available
Room temperature, 2-8°C, -80°C, Vapor-phase LN2
cGMP document and batch record development
We develop records for product traceability and in-process testing and specifications.
Rapid technology transfer of developed processes
PCM can efficiently review and transfer your current manufacturing process into our QMS. Experienced cGMP technicians on staff to rapidly expedite your process into production.
Manufacturing Case Study
Allogeneic MSC Manufacturing
Performance Cell manufactured cGMP allogeneic MSC final cell product from adipose tissue for an FDA-approved Phase 1 IND
The project included master cell bank and final cell product lot release testing
Manufacturing Case Study
Feeder Cell Manufacturing
Performance Cell manufactured cGMP feeder cell lines for support of manufacturing of multiple cGMP human therapy products for FDA-approved Phase 1 and 2 clinical trials
The project included complete tech transfer from university and third-party CMO facilities to PCM facilities and process validation
Manufacturing Case Study
Feeder Cell Manufacturing
Performance Cell manufactured cGMP feeder cell lines for support of manufacturing of multiple cGMP human therapy products for FDA-approved Phase 1 and 2 clinical trials
The project included complete tech transfer from university and third-party CMO facilities to PCM facilities and process validation
Manufacturing Case Study
Autologous Stem Cell Manufacturing
Performance Cell manufactured multiple lots of final cell product from cGCP clinical autologous tissue collections
The project included clinical tissue collections, shipment logistics, and cGMP manufacturing of seed lots and final cell product with lot release testing
