The Laboratory for Cell and Gene Medicine (LCGM) is a purpose-built biologics production facility located in Palo Alto, California. The approximately 10,000 ft2 facility is designed to manufacture, test and store cell and viral vector products for phase I/II clinical investigations conducted under Investigational New Drug (IND) application as specified in 21 CFR Part 312 and in accordance with US FDA current Good Manufacturing Practices (cGMP - 21 CFR Parts 210, 211) and European Medicines Agency (EMA) regulations. The facility is led by Interim Executive Director Dr. Bruce Burnett and managed by experienced professionals with specific training in Good Manufacturing Practices.
LCGM manufactures and engineers clinical materials (cells and vectors) to be used with patients. It possesses a rare expertise in manufacturing those treatments and providing support via clinical trial process development, quality systems and regulatory management.
Cell processing is conducted in one of four cell processing suites containing equipment for cell washing and formulation, density separation, magnetic bead selection, flow cytometric cell sorting and culture. Each suite is a separate, ISO Class 7/EMA Grade D processing area, accessed by a dedicated gown room/pass-through. The suites are accessed through an ISO Class 8 general area, which includes a gowning airlock, material airlock, material staging / storage room, general storage room, media preparation room, and irradiator room. Additional ISO Class 8 space for media preparation, cryopreservation and released material storage is provided throughout the cell manufacturing area.
The Laboratory for Cell and Gene Medicine houses a dedicated Quality Control Laboratory with equipment and analytical capability to perform cell culture assays, bacterial assays, biologic and general chemistry test methods. Shipping, receiving, warehouse and utility areas are included in the facility. Storage is strictly segregated and access to materials associated with projects subject to cGMP regulations is available only to authorized production or Quality Systems personnel. Offices, open office spaces, and conference rooms and other support areas are finished and furnished conventionally to the usual high standards typically adopted for laboratories and offices throughout the campus.
The Laboratory for Cell and Gene Medicine staffing is organized into independent groups for Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs.
Process Development and Manufacturing (PDM)
The Process Development and Manufacturing staff perform process development, qualification and manufacturing of all clinical batches of cell and/or gene therapy products.
Quality The quality team is divided into two groups:
- Quality Control (QC) and Analytical Development. The Quality Control group performs analytical and release testing for cell and gene therapy products manufactured at LCGM. The Quality Control group’s in-house testing program includes: Endotoxin, Mycoplasma, qPCR, environmental monitoring (EM), and flow cytometry (with a state-of-the-art cytometer). For testing that is not performed in-house, the Quality Control group coordinates shipment of samples to qualified testing facilities. The Quality Control group also develops new assays or optimizes existing assays for testing of clinical products.
- Quality Assurance (QA). LCGM has a robust quality system that includes but is not limited to the management of procedures, records, supplies & reagents, product storage, vendors, equipment, employee training, process validation, complaints, receipt of product, and distribution of product by the Quality Assurance group. The Quality Assurance group also performs periodic assessments of the health of the quality system and reports the status to the LCGM Executive Committee.
Regulatory Affairs (RA)
The Regulatory Affairs staff is responsible for creating and maintaining regulatory documentation on investigational products according to federal state, local or institutional requirements and supports IND development and master file creation and maintenance for the Laboratory for Cell and Gene Medicine facility and Stanford Cell and Gene Therapy products.
The Laboratory for Cell and Gene Medicine is the bridge in bench to bedside translational medicine. Our staff is dedicated to improving the health and life of patients. Our mission is to create quality manufacturing processes for Cell and Gene-based therapies for the treatment of pediatric and adult patients with incurable disease.
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