GMP & GTP
Manufacturing 

From Draw-to-Thaw™: Optimized
cGMP & GTP Manufacturing for Advanced Therapies

Service
Description

At CCS, we provide end-to-end cGMP manufacturing solutions tailored for advanced cell therapy developers ensuring regulatory compliance, scalability, and high-quality production. Our expertise spans both autologous and allogeneic (off-the-shelf) therapies, enabling seamless transitions from process development to commercialization. Whether scaling out or scaling up, our focus remains on efficient, cost-effective manufacturing. 

As a non-profit organization, CCS delivers exceptional value while maintaining strict GMP and regulatory standards. We specialize in manufacturing optimization through process closure and automation, and our unique Draw-to-Thaw™ model integrates cell sourcing, processing, and cryopreservation for a true vein-to-vein solution.

From tech transfer and advanced bioprocessing to rigorous quality control, we accelerate the path from development to market for cell therapy products.

Why
Choose us?

ISO7 Clean Rooms

Twin clean rooms in Louisville, KY support clinical phase I-II projects with platform-agnostic capabilities for cell isolation, enrichment and depletion, cell wash and volume reduction, cell culture, expansion and differentiation, viral transduction, formulation and cryopreservation.

GTP Manufacturing

Across two locations, our teams utilize greater than 2000 sq ft of lab space for the processing of intermediate GMP products and clinical apheresis for infusion per CFR 1271, ensuring the highest quality possible for irreplaceable biomaterials. This includes bone marrow processing, mononuclear cell enrichment, fill/finish of final drug product, and cryopreservation of apheresis material.

Quality Control Labs

Labs adjacent to GMP manufacturing suits support the conduct of flow cytometry, cell analysis, and release testing of manufactured products.

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