Process and Analytical Development

Applied StemCell’s development services help our clients design and develop robust processes and analytical methods providing the foundation for success in the clinic through commercialization. Our team’s extensive experience in all stages of cell and gene therapy development and commercialization helps guide your plans and build for the long-term goals of consistent quality, cost effectiveness, and scalability while applying a phase-appropriate approach in the early stages of CMC development.

Cell therapies with or without gene modification require thorough characterization in both analytics and process. We have a wide range of analytical capabilities in flow cytometry, qPCR, ELISA, cell-based assays, imaging, compendial methods, etc. Using Quality by Design (QbD) principles and DOE studies, our expert team can help you define and measure your product’s critical quality attributes (CQAs) with scientifically justified, qualified, and validated analytical methods to meet the regulatory requirements along your product’s unique specifications and clinical development journey, ensuring safety, quality, identity, purity, and potency every step of the way.

Our deep knowledge of cell biology across a wide range of cell types (iPSC and many of their differentiated tissue types, HPSC, MSC, NK, T-cells, T-Reg, PBMC, APC, macrophage, etc.) enhances your team’s know-how to characterize and optimize your manufacturing process for future scale. We can help you fully define your critical process parameters (CPP) and, importantly for scale and robustness, which parameters are flexible.

The ASC team brings a wealth of real-world CMC development experience with regulatory feedback for cell therapy products from pre-clinical through high-volume commercial scale. As your partner, we can help you design and execute drug substance and drug product GMP and non-GMP stability studies, process improvements, scale-up/scale-out, phase-appropriate comparability studies, raw material selection and vendor qualification.

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