The Biotherapeutic Core Facility (BTCF), formerly known as the Cell Therapy and Cell Engineering Facility (CTCEF), at Memorial Sloan Kettering Cancer Center is a FACT-accredited facility dedicated to advancing clinical research in cell engineering and adoptive cell therapies. Our mission is to develop, validate, and support Phase I and Phase II clinical trials, collaborating closely with researchers and clinical teams to bring innovative treatments to patients while maintaining quality, safety, and compliance.

BTCF has the capacity to produce a wide range of cellular components, including T cells, natural killer (NK) cells, and hematopoietic progenitor cells (HPSCs). The facility also specializes in genetic engineering, vector production, master cell bank generation, and large-scale manufacturing of cGMP-grade retroviral vectors. Our quality control (QC) laboratory performs rigorous biosafety testing to ensure the safety and efficacy of cellular products for patient use.

Our Capabilities

cGMP Manufacturing

• Processing and cryopreservation of apheresis products
• Purification of immune cell populations (e.g., T cells, NK cells) for adoptive cell therapy
• Generation and cryopreservation of master cell banks (MCB)
• Production of retroviral vectors and CAR-T cells using multiple platforms
• Hematopoietic stem and progenitor cell (HSPC) engineering
• Gene editing and preparation of cellular products for infusion

GLP Services

• Cell line development and seed bank preparation
• Stem cell purification and T cell preparation
• Vector preparation
• DNA extraction from blood, bone marrow, biopsies, and cerebrospinal fluid

Process Development & Support

• Consultation and pre-clinical small-scale testing
• Process design and verification
• Assay development

Quality Control Testing

• Reagent qualification (e.g., antibodies, FBS, human serum)
• Mycoplasma and endotoxin testing
• Cytotoxic T lymphocyte (CTL) assay
• ELISA
• ddPCR, qPCR, PCR
• Flow cytometry
• Vector envelope detection and titration
• Cytokine-independent growth assays
• Stability studies

Regulatory Support

• Standard Operating Procedure (SOP) development
• Master Control Production Record (MPCR) development
• Quality report generation
• Certificate of Analysis (COA) issuance
• Assistance with pre-IND FDA meetings
• Assistance with IND chemistry, manufacturing, and control (CMC) section preparation
• Internal and external audits
• Product chain-of-custody and distribution control

With cutting-edge technology, a robust regulatory framework, and a highly skilled team, BTCF is committed to driving innovation in cell therapy research and clinical translation, helping to bring next-generation treatments to patients in need.

The Cell Therapy and Cell Engineering Facility (CTCEF) is a FACT (Foundation for the Accreditation of Cell Therapy) accredited facility that plays a vital role in advancing clinical research at Memorial Sloan Kettering (MSK). The mission of the Core is to develop, validate, and support the implementation of phase I and phase II clinical trials for cell engineering and adoptive cell therapies at MSKCC. Our goal is to advance novel treatments that improve patient outcomes through seamless collaboration with researchers and clinical teams, while upholding high standards of quality, safety, and compliance.

The Core has the capacity to produce various cellular components, including T cells, natural killer cells, dendritic cells, and hematopoietic progenitor cells (HPSCs). It also supports genetic engineering, vector producer cell line development, master cell bank generation, and large-scale production of cGMP-grade retroviral vectors. The QC laboratory performs biosafety testing critical for the release of cellular products used in patients.

cGMP (CTCEF is a FACT-accredited cGMP facility)

• Processing and cryopreservation of apheresis product
• Purification of immune cell populations, such as T cell, NK cells for adoptive cellular therapy
• Generation and cryopreservation of master cell bank (MCB)
• Production of retroviral vector
• Production of CAR-T cell with multiple platforms
• Hematopoietic stem and progenitor cell engineering
• Gene editing
• Preparation of cellular product for infusion

GLP

• Cell line development
• Seed bank preparation
• Stem cell purification
• T cell preparation
• Vector preparation
• Blood/BM/biopsies/cerebrospinal fluid DNA extraction

Process Development and Support

• Consultation
• Pre-clinical small-scale testing
• Process design and verification
• Assay Development

Quality Control Testing

• Reagent (such as antibody, FBS, Human Serum) qualification
• Mycoplasma
• Endotoxin
• Cytotoxic T lymphocyte (CTL) assay
• ELISA
• ddPCR
• qPCR
• Flow cytometry
• Vector envelop detection
• Vector titration
• Cytokine independent growth assay
• Stability study

Regulatory

• Standard operation protocol (SOP) development
• Master control production record (MPCR) development
• Quality report generation
• Certificate of analysis (COA) issuance
• Pre-IND FDA meeting assistance
• IND Chemistry, Manufacturing and Control (CMC) section preparation assistance
• Internal and external audits
• Product chain of custody and distribution control