Memorial Sloan Kettering Cancer Center
Contact Info:
Xiuyan Wang
417 E 68th Street
Mortimer B. Zuckerman Research Center
New York, NY 10065
https://www.mskcc.org/research/ski/core-facilities/biotherapeutics
Grants and Identifiers:
RRID: RRID:SCR_027797
Instrumentation:
Services Provided:
ADCC (Antibody-Dependent Cellular Cytotoxicity) Assays
Cell Line Development (such Vector Producer Cell Line, Or ADCC Target Cell Lines)
Cell Subset Purification (CD3, CD4, CD8, CD34, CD56)
CMC-Enabling Studies (e.g., Cell Preparation For Pharmacology/toxicology)
Gene Editing & Site-Specific Gene Transfer
GLP Cell Purification (T, NK, CD34 Etc.)
Immune Cell Transduction (T, NK, HSC Etc.)
Large-scale Vector Stock Production (retro And Lenti)
Patient Sample Processing (PBMC Purification, FACS, Vector Incorporation In Genome)
Retroviral & Lentiviral Vector Titration
T Cell Expansion & Formulation
Vector Construct Cloning And Amplification (e.g., SFG Retroviral Vector Constructs)
Relevant Publications:
Description:
The Biotherapeutics Core Facility (BTCF) serves as the bridge that translates research discoveries into clinical applications, specializing in tech transfer, process development, and cGMP manufacturing of cellular products for clinical trials. BTCF partners with investigators across MSK to advance cell and gene therapy programs from bench to bedside, providing support for IND CMC submissions and Phase 1/Phase 2 clinical manufacturing. **Tech Transfer & Process Development** BTCF translates research-laboratory processes into GMP-compliant manufacturing workflows ready for clinical use. Services include process design and optimization, scale-up, development of Standard Operating Procedures (SOPs) and batch records for cell processing, cell engineering, and vector production, and process qualification. For each clinical program, BTCF develops a comprehensive set of Critical Quality Attributes (CQAs) and testing plans to support IND CMC filings and ensure product quality and safety. **cGMP Cell Therapy Manufacturing** Full-scope cGMP manufacturing of autologous and allogeneic cell products, including patient cell handling from purification and transduction through expansion and final formulation, in support of Phase 1 and Phase 2 clinical trials. **Vector Production** Production of viral vector stocks, including retroviral vector production under cGMP conditions for clinical applications, and lentiviral vector production under research-grade conditions. **Analytical & Testing** Characterization of cell lines, patient cells and vector stocks for phenotype, potency, purity, including gene transfer and expression analyses by FACS and VCN. **Cell Line Development & Molecular Biology Support** Cell line development, molecular cloning of genes of interest into vector backbones.
