Cell Therapy Analytical Services

At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current regulatory environment, and have a history of the development and qualification of analytical methods. We operate with a forward-looking methodology by deploying robust and reproducible analytical methods during preclinical development for a seamless transition into manufacturing. The analytical methods created during preclinical development play a major role in any regulatory filing and can potentially accelerate product and process development. Our team implements robust QC assays to measure the quality and consistency of your final product throughout the process. Our focus is to ensure the identity, purity, safety, and potency of your cells. Our services are performed under CGMP conditions in compliance with the following requirements: ICH Q2 (R1), European and US pharmacopeia, FDA, and EMA. Our analytical capabilities include:

• Method Development
• Characterization
• Safety Testing
• Validation
• Release Testing
• GMP Release and Stability Testing
• Comparability Studies
• Raw Material Performance Testing

Tests performed:

• Potency
• Phenotype by Flow Cytometry
• Viability / Vitality
• VCN Vector Copy Number
• Replication Competent Virus
• Cytokine Independent Growth
• Cytokine Expression Quantitation
• Cytotoxicity
• Sterility
• Endotoxin
• Mycoplasma
• Visual Inspection
• qPCR / RTqPCR
• ELISA
• MSD Multiplexing Technology