GMP Manufacturing for Phase I and II Trials

Over 45 Years of Experience

List Labs’ Campbell, CA site manufactures cGMP drug substance and drug products approved for use in Phase I and II clinical trials. As an industry-leading CDMO, List Labs has over 45 years of experience in manufacturing bacterial-based products, including live biotherapeutic products (LBPs), bacterial toxins, proteins, and polysaccharides.

Let’s Advance Together

List Labs’ GMP Manufacturing Services

With the know-how and agility to meet the unique needs of your project, List Labs
offers the following GMP manufacturing services:

Master Cell Banks (MCB) and Working Cell Banks (WCB)

Placebo

Vehicles

Biological Intermediates

Drug Substances

Drug Products

cGMP Quality & Regulatory Compliance

To ensure compliance with cGMP, our contract manufacturing services are governed by a robust Quality Management System (QMS).

List Lab’s quality program for GMP manufacturing consists of:

Standard Operating Procedures Document Control Employee Training

Facility Maintenance Equipment Maintenance, Calibration, and Validation

Raw Material and Component Control Nonconforming Events

Change Control Risk Management

List Labs’ Drug Manufacturing License & Drug Master File Experience

We hold a Drug Manufacturing License with the State of California Department of Public Health and have filed several Drug Master Files with the FDA and an Investigational Medicinal Product Dossier (IMPD) and supported client IND filings on behalf of our clients

List Labs also complies with 21 CFR 210, 211, as well as ICH and Regulatory Guidelines, as applicable, for early-stage INDs and IMPDs.

List Labs’ Clinical-Scale Facility

Our state-of-the-art California facility and — our vision for a supplemental commercial facility — are designed to support the quality of your products.

Currently, GMP production occurs within our expertly designed manufacturing suites in our California facility, which features:

Several independent production suites designed for process containment and segregation

Independent gown rooms

Dedicated HEPA filtered air supply and exhaust

Rooms that all 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 provided by biological safety cabinets within ISO 7 production suites

Parallel cGMP manufacturing capabilities that streamline project timelines and prevent delays

Contact us for GMP products

Send us an email and let’s get started.