Quality Control
& Regulatory
Quality Control Testing for Cell Therapy:
Ensuring Safety, Purity & Potency
Service
Description
At CCS, we understand that quality is the foundation of successful cell therapy development and manufacturing. Our Quality Control (QC) Testing services are designed to ensure the safety, purity, identity, and potency of your cell therapy products, helping you meet regulatory requirements while accelerating your path to market.
As a trusted CDMO partner, we provide a comprehensive suite of GMP-compliant analytical testing services tailored to the complexities of cell-based therapies. With a deep commitment to precision, compliance, and efficiency, we help you de-risk your development process and achieve consistent product quality.
Why
Choose us?
Seamless Tech Transfer
Contract Testing
CMC Support
Service
Offerings
Microbiology
- Bacterial endotoxin testing USP <85>
- Gram stain
- Sterility testing
- USP <71> (direct inoculation)
- Rapid via BACT/ALERT® 3D platform
- Environmental monitoring
- Contact and settle plates
- Active air sampling (total particle and viable microbial)
QC Testing
- Complete blood count (CBC) analysis
- Cell count and viability
- Flow cytometry (up to 12 colors)
- Potency assays (e.g., colony forming unit assay – STEMvision™)
Additionally, we offer bespoke assay development services to accommodate our clients’ unique needs for testing that is not available off-the-shelf. Please see our Assay Development Services.
Regulatory Support
Our in-house regulatory team can guide clients through phase appropriate considerations for later stage clinical and commercial success. When additional support such as regulatory writing is required, we can connect clients with our preferred partners for an integrated, seamless experience.