List Labs is a premier contract services organization, with over 25 years’ experience manufacturing bacterial based products including live biotherapeutic products (LBP), bacterial toxins, proteins, and polysaccharides. We offer contract development and manufacturing (CDMO) services and have manufactured cGMP drug substance and drug products approved for use in Phase 1 and 2 clinical trials in the US and Europe.
Background on GMP
List Labs offers the following GMP manufacturing services:
- Master Cell Banks (MCB) and Working Cell Banks (WCB)
- Biological Intermediates
- Drug Substances
- Drug Products
List Labs is flexible to meet the unique needs of your product.
The List Labs facility is designed to support the quality of your products. GMP production occurs within our expertly designed Manufacturing Suite. The Manufacturing Suite consists of several independent Production Suites designed for process containment with independent gown rooms and dedicated HEPA filtered air supply and exhaust. All rooms within the manufacturing suite meet ISO 7 or ISO 8 guidelines (Class 10,000 and 100,000, respectively) for pharmaceutical production. ISO 5 (Class 100) environments for critical aseptic operations, are provided by biological safety cabinets within ISO 7 Production Suites. Parallel cGMP manufacturing capabilities steamlines project timelines and avoids delays.
Quality & Regulatory
GMP contracting manufacturing at List Labs is governed by our Quality Manageement Systems which ensure compliance with cGMP’s. List Labs holds a Drug Manufacturing License with the State of California Department of Public Health. We have filed several Drug Master Files with the FDA and Health Canada on behalf of our clients and can provide support to clients for IND filings. List Lab’s quality program for GMP manufacturing consists of:
- Standard Operating Procedures
- Document Control
- Employee Training
- Facility Maintennce
- Equipment Maintenance, Calibration, and Qualification
- Raw Material and Component Control
- Nonconforming Events
- Change Control
- Risk Management