Analytical
Development
Precision Analytical Solutions
for Cell & Gene Therapies
Service
Description
At CCS, we provide Analytical Development for cell therapy, ensuring that your process and product meets the highest standards of quality, safety, and efficacy. Our specialized team leverages state-of-the-art technologies to develop, and tech transfer, robust analytical methods tailored for the unique needs of cell-based therapies. Whether you’re advancing an autologous or allogeneic therapy, our comprehensive services help you optimize your analytical strategy, enabling you to meet phase appropriate regulatory requirements.
Why
Choose us?
Expertise in Cell Therapy Analytics
Method Validation Expertise for Every Phase
Comprehensive Testing for Product Characterization
Service
Offerings
Method Development
We design and optimize analytical methods to ensure accurate testing of cell identity, potency, purity, and sterility for your therapy.
Stability Studies
We design stability-indicating assays to assess long-term storage and shelf life, ensuring reliable quality control for cell therapy products.
Process Monitoring & In-Process Testing
We conduct in-process testing to ensure process control, consistency, and product quality, using metrics like cell count, viability, phenotype analysis, and advanced proteomic/genomic monitoring.
Release Testing
We develop assays to confirm that your cell therapy product meets all specifications and critical quality attributes for clinical use.
Characterization of Cell-Based Products
We provide flow cytometry, ELISA, PCR, and other assays to verify cell identity, purity, and potency, ensuring regulatory and clinical compliance.
Documentation
We provide comprehensive, traceable documentation to support regulatory filings and ensure a seamless submission process.