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

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cGMP document and batch record development

We develop records for product traceability and in-process testing and specifications.

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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

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Performance Cell manufactured cGMP allogeneic MSC final cell product from adipose tissue for an FDA-approved Phase 1 IND

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The project included master cell bank and final cell product lot release testing

Manufacturing Case Study

Feeder Cell Manufacturing

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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

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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

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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

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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

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Performance Cell manufactured multiple lots of final cell product from cGCP clinical autologous tissue collections

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The project included clinical tissue collections, shipment logistics, and cGMP manufacturing of seed lots and final cell product with lot release testing

Join the growing list of clients that have made the switch.