Cell and Gene Therapy Assay Development Services
Products & Services
Information
https://missionbio.com/products/pharma-assay-development/pad-for-cell-gene-therapy/
Mission Bio’s Cell and Gene Therapy Assay Development Services provide a collaborative, end-to-end solution for designing custom, fit-for-purpose single-cell assays that de-risk both ex vivo and in vivo gene therapy programs from early discovery through clinical transfer. The team partners with developers to engineer tailored assays that validate critical quality attributes (CQAs) such as vector copy number (VCN), transduction efficiency, on- and off-target editing, and chromosomal integrity specifically for a client’s unique therapeutic product or model system. Crucially for in vivo therapies, where the patient’s body acts as the manufacturing site, these assays can characterize heterogeneous editing outcomes in extracted tissue samples, confirming precise delivery and safety in preclinical models before human trials. These services encompass the entire assay lifecycle, including custom panel design, method qualification, and bioinformatic analysis, ultimately delivering a GxP-ready, transferable assay that supports IND-enabling studies and lot release testing while satisfying rigorous regulatory safety standards.
