Our manufacturing suite is 7,040 sq. ft. and houses several independent production suites. These suites are specifically designated for the various stages of product manufacture such as fermentation, purification and filling. Each production suite is separated from all adjacencies via air pressure differentials.
The manufacturing suite was built and designed for cGMP production and for the production of products from BL1, BL2 and BL3 bacteria. The facility complies with 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals as well as the Biosafety in Microbiological and Biomedical Laboratories 5th edition and Appendices G and K of the NIH Guidelines for Research Involving Recombinant DNA Molecules. Independent areas for the preparation of solutions and clean equipment, for decontamination and cleaning of used equipment, and for testing are also provided. Materials, products and personnel move through the facility in specific pathways. Personnel gown in a manner which supports the clean environment within each production suite. Surfaces are smooth and cleanable. Prior to cGMP manufacturing, the production suite will be disinfected to ensure no cross contamination with other products can occur. Supply air in the manufacturing suite is 100% single pass HEPA filtered air to provide ISO 7 and 8 environments. Biological safety cabinets are located in all production suites to provide ISO 5 environments for critical asepetic operations such as master/working cell bank production, inoculation of starter cultures, final filling of products, purity and sterility analysis of the bacterial cultures and final products.
Utilities supplying the manufacturing suite include Plant Steam for non-product contact equipment jackets, Clean Steam for autoclave sterilization and fermenter sterilization, a reverse osmosis-deionizing water system supplying USP purified water to points of use throughout the facility, and HEPA filtered air supplies to all manufacturing areas. Nitrogen is also supplied to all production suites from a compressed tank manifold. These systems have been validated for use. See a list of our equipment here.
In addition to the cGMP manufacturing suite, separate laboratory areas are available for quality control testing, assay development and purification development activities.
Most List Labs’ products are intended as research reagents (Research Grade). However, several can be produced as GMP products for use in humans. Further explanation on the differences between reagent grade products and GMP can be found on our blog.
Validation of Critical Processes:
Sterilization and depyrogenation processes for equipment, supplies and media have been validated. Decontamination cycles in the dedicated decontamination autoclave have also been validated. The cleaning validation program includes all equipment that is either not dedicated to one product or does not have disposable product contact surfaces; this includes the 100 L fermenter.
The Quality Assurance (QA) department is responsible for ensuring compliance to 21CFR 211 requirements which includes raw material control and release, assay qualification, component and product disposition, deviation control, review and approval of Master Production and Control Records and completed Batch Production and Control Records, SOPs, validation protocols, equipment qualification and calibration and ensuring employee training and compliance to Good Manufacturing Practices. QA ensures the timely closure and final disposition of all deviations that occur during any phase of the production or testing, ensuring that adequate investigations and corrective actions have been completed.
Raw Material Control:
Raw materials used in production are compendial grade where available. Note that certain medium components are not available as compendial. For cGMP production, all raw materials are sampled and tested for identity. Non-compendial materials will be tested according to List Labs approved specifications or released upon the manufacturer's Certificate of Analysis. The majority of the raw material testing will be contracted to a QA approved testing laboratory, specializing in USP compendial testing. Non-USP testing will be performed by the QC department following approved SOPs.
The Director of Quality Assurance has the responsibility of preparing and maintaining Drug Master Files (DMF) at the FDA for the benefit of our clients. List Labs holds a Drug Manufacturing License from the State of California, required to produce IND and commercial products.
See a list of additional services below: