Clinical Manufacturing

Our state-of-the-art facility in California supports clinical projects through Phase II. List Labs has over 25 years of expertise producing bacterial-based drugs at this site, making us the perfect fit for your cGMP-compliant manufacturing project — including live biotherapeutic products (LBP), recombinant proteins, polysaccharides and toxins.

California Facility

List Labs’ clinical facility has:

26,921 sq. ft. Facility
7 GMP Manufacturing Suites (2 ISO7 and 5 ISO8)
Designed for up to BSL3 and Spore Formers
Cultivated >100 Bacterial Species
Produced >100 Different Type of Bacterial Products
500L Volume Capacity with 500L Sartorius Single Use Stirred Tank Reactor and ÄKTA ReadyFlux
Single Use and Stainless Steel Fermenter Options
Manufactured >30 GMP Products

List Labs’ GMP Products by the Numbers

>300 Product Types Manufactured
>100 Reagent Grade Products
168 GMP Product Lots
80 Drug Substances
35 Drug Products
19 Master and Working Cell Banks
26 Placebos
8 Vehicles
34 Client Projects
2 Client Products in Phase 3 Clinical Trials
2 Client Products in Commercial Production

Overview of Capabilities

With an unparalleled legacy of expertise in LBP manufacturing, our California facility offers development and clinical-scale manufacturing of a range of products:

GMP Products
Live Biotherapeutic Products
Bacterial Toxins and Polysaccharides
Recombinant Proteins
Toxoids
FRET Peptides, Native Substrate
Vaccine Carrier Proteins & Adjuvants
Antibodies

Commercial Facility Coming Soon

Learn more about our vision to add commercial manufacturing at a new site.