GMP Shared Resource
Overview
The GMP Facility provides MSK investigators and external collaborators with access to GMP-compliant cleanroom facilities, Quality Control (QC) services, and operational support for the development and clinical translation of advanced biotherapeutics. The facility supports a broad range of therapeutic modalities, including cell therapies (e.g., CAR-T and other engineered immune cell products), gene therapies, mRNA-based therapeutics and vaccines, viral vectors, and other advanced therapeutic products.
Through centralized quality systems, specialized analytical testing, and expert operational oversight, the GMP Facility enables investigator-initiated studies, translational research, and early-phase clinical trials while ensuring regulatory compliance and efficient access to shared GMP resources.
The GMP Facility provides an integrated environment for the clinical translation of advanced biotherapeutics by combining GMP-compliant infrastructure, specialized Quality Control services, and experienced operational support.
Our facility offers:
- GMP-compliant cleanroom infrastructure
- Integrated Quality Control laboratory
- Specialized assay development and validation
- Support for a broad range of advanced biotherapeutic modalities
- Experienced GMP operations and quality personnel
- Centralized scheduling and project coordination
- Regulatory-compliant quality systems supporting clinical translation
Core Services
The GMP Facility provides the infrastructure and operational support required for compliant clinical manufacturing, including:
- GMP cleanroom scheduling and suite management
- ISO-classified cleanroom facilities
- Equipment qualification and lifecycle management
- Environmental monitoring
- Equipment calibration and preventive maintenance
- Material receipt, quarantine, storage, and inventory management
- Raw material verification and traceability
- Controlled temperature storage (refrigerated, frozen, and cryogenic)
- Chain of custody documentation
- Facility alarm and monitoring systems
- Batch record support
- Deviation and change control management
- Quality assurance and regulatory support
- Product storage and distribution support
The GMP Quality Control Laboratory provides analytical testing, assay development, stability studies, and quality documentation to support clinical manufacturing and product release.
Product Testing
- Cell viability testing
- Mycoplasma testing
- Endotoxin testing
- GALV testing
- SFG Vector Copy Number (VCN) testing
- Cytotoxic T Lymphocyte (CTL) assays
Assay Development & Validation
- CTL assay development
- Assay qualification and validation
- Method development and optimization
- Clinical assay support
Stability Studies
- Stability study design and execution
- Short- and long-term stability studies
- Stability sample management
- Stability reporting
Quality Documentation
- Certificate of Analysis (CoA) preparation
- Analytical data review
- QC documentation supporting product release
- CMC support for IND applications
The GMP Facility is designed to support compliant clinical manufacturing through dedicated cleanroom infrastructure, controlled personnel and material flow, and specialized laboratory space.
Facility features include:
- Multiple ISO-classified cleanroom processing suites
- Dedicated Quality Control laboratory
- Material quarantine and staging areas
- Personnel and material airlocks
- Controlled gowning areas
- ISO 7 production corridors and cleanrooms
- ISO 5 Biological Safety Cabinets (BSCs) for critical processing
- Controlled storage and environmental monitoring systems
ISO Classification
| Area | ISO Classification |
|---|---|
| Material Quarantine | ISO 8 |
| Quality Control Laboratory | ISO 8 |
| Locker Rooms | ISO 8 |
| Gowning Areas | ISO 7 |
| Production Suites & Hallways | ISO 7 |
| Biological Safety Cabinets (BSCs) | ISO 5 |
The GMP Facility supports:
- MSK investigators
- Academic collaborators
- Industry-sponsored projects
- Cell and gene therapy programs
- Translational research initiatives
- Early-phase clinical trials
To request GMP Facility services:
- Submit a service request through iLab
- Complete the GMP Scheduling Request Form for clinical manufacturing requests
- The GMP team will review your project requirements and scheduling needs.
- Facility reservations and QC services will be coordinated with the project team.
- Billing will be managed through iLab.
For questions regarding facility access, scheduling, Quality Control services, or project planning, please contact the GMP Facility team: [email protected].
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