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.