MC3 oversees two GMP Laboratories. The Robertson cGMP Laboratory and the MPACT GMP Laboratory. The GMP manufacturing is supported by a team of over 50 individuals who are subject matter experts, including facilities and engineering, technical operations, quality control and analytics, inventory management, and regulatory and quality. The facility supports the manufacturing of phase 1 to licensed products, including investigator initiated and external sponsor supported projects.
Analytic testing includes endotoxin, BacT sterility, cell counting, flow cytometry, mycoplasma, and gram stain.
Robertson cGMP Laboratory
The Robertson cGMP Laboratory is a FACT accredited, FDA registered, multi-purpose facility that includes 13 individual rooms and 3 manufacturing rooms, covering 3150 GSF. This facility is dedicated to the manufacturing of biologics and processing of tissues for human clinical use.
The facility’s mechanical systems, architectural features and finishes meet US Food and Drug Administration as well as relevant international requirements for controlled clean room manufacturing environments and aseptic processing. Some of its attributes include:
- Ultra low particulate air (ULPA) filters and air-handling units are configured to deliver particulate-free air at a positive air pressure respective to surrounding rooms and spaces.
- All critical parameters (temperature, pressure, and humidity) are monitored.
- Periodic environment monitoring is performed to assure microbiological control.
- All manufacturing equipment and utilities are validated in accordance with biopharmaceutical standards.
- Standard operating procedures assure that all systems are properly maintained and functional.
- Access to the facility is controlled.
The facility includes manufacturing and support operations on one floor consisting of CNC, ISO 8, and ISO 7 areas.
MPACT GMP Laboratory
This phase 1 focused facility supports first in human clinical trial cell production. The facility has 2 ISO7 clean rooms, supply record storage, and quality control testing space. The facility has a CliniMACS Prodigy® for automated cell processing and MACSQuant® Analyzer for flow cytometry.