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MSKCC-Biotherapeutics Core Facility (Biotherapeutics)

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417 E 68th Street

Mortimer B. Zuckerman Research Center

New York, NY 10065

United States

https://www.mskcc.org/research/ski/core-facilities/biotherapeutics

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Primary Contact:

Xiuyan Wang

Facility RRID

RRID:SCR_027797

Facility Details

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.

Facility Policies

Services are offerred outside of

Consulting is offerred outside of Memorial Sloan Kettering Cancer Center

Last Updated: 04/30/2026