Right-First-Time cGMP Manufacturing
Landmark Bio’s cGMP manufacturing facility and services have been designed and built for the production of advanced therapies. The bedrock of our cGMP services is an industry-leading track record of right-first-time technology transfer and cGMP batch release.
In addition, all cGMP manufacturing services are supported by a rigorous, phase-appropriate Quality Management System, on-site Quality Control testing, and cutting-edge digital tools including integrated enterprise resource planning and QC LIMS.
GMP Manufacturing Services Built for Cell and Gene Therapies
Landmark’s modular and reconfigurable manufacturing services are designed to support a diverse range of cell and gene therapy modalities, including:
GMP Manufacturing Facilities - Built for Cell and Gene Therapies
Located in Watertown, Massachusetts, USA, the Landmark Bio facility is approximately 44,000 square feet. Designed to be reconfigurable, the modular cGMP Suites have been purpose-built to address the cGMP bespoke requirements of advanced therapies manufacturing.
The design of Landmark Bio’s facility was reviewed with the FDA in a Type C meeting prior to construction to ensure robust HVAC design, personnel and material flows. Each suite has independent HEPA-filtered air handlers and is equipped with process gases via qualified distribution networks. Additional support rooms include cGMP warehousing, kitting, controlled-rate freezing, and a freezer farm with multiple 2–8°C, –20°C and –80°C temperature control units. The manufacturing space includes suites equipped with BSCs, incubators and cell counters. The Large-Scale Processing Suite is also equipped with downstream processing equipment including tangential flow filtration and chromatography.
44,000 sq. ft. integrated facility in Watertown, MA
Innovation and Development Labs
- Discovery Research
- Process Development
- Analytical Development
- Formulation Development
GMP Manufacturing
- 5 Cell Processing Suites
- 2 Viral Vector Suites
- 1 mRNA and LNP Suite
- 1 Fill & Finish Suite
Quality Control Labs
- Bioanalytical
- Microbiology
Office Space