Karen Crawford, Ph.D., President
Eva Purro, Director of Quality Assurance
Dom C. Ouano, Marketing
While most of List Labs’ products are intended as research reagents (Research Grade), several can be produced as GMP products for use in humans. Below are key differences between the two.
Research Only VS Preclinical/Clinical/Human Use
Reagent grade products for research only are labeled “not for human use” but are produced using good laboratory practices. These reagents are readily available on our website and any quantity can be purchased. Products intended for human use are produced under cGMP (current Good Manufacturing Practices, see the Code of Federal Regulations 21 CFR 211) and are provided to clients with a customized contract.
cGMP = Higher Production Standards
Producing compounds under cGMP regulations is a more costly process compared to reagent grade. cGMP compliance includes all aspects of production: documented training programs, QA issued production records, dedicated production suite preparation, testing and release of raw materials, analytical method qualification dedicated supplies, and validated cleaning methods. In addition, a Drug Master File may be submitted to the FDA, which can be cross referenced by our GMP customers.
One example of a product produced as both reagent grade and GMP grade is HPT™ E. coli O113 LPS. Although a chemist may not be able to tell the difference between the reagent grade and the cGMP material, the difference is in the compliance to the GMP’s as described above. Our reagent grade material is produced with good laboratory procedures, however it is not compliant to GMP. Consequently, reagent grade E. coli LPS is not for human use and cGMP LPS may be applied “for human use” per FDA approval. cGMP for human use is not so much a property of the E.coli LPS as it is describing the environment and procedures surrounding the preparation of the compound.
Our LPS from E. coli O55:B5 or E.coli O113, Products #203, #423 and #433, are reagent grade products and are often used in research, particularly for inducing the maturation of Dendritic Cells.
We also provide cGMP LPS from E.coli O113 on a contract basis, which is made compliant to GMP and is appropriate for FDA approved use in humans.
Since 1978, List Labs has been known as a manufacturer of fine research reagents. Located in Silicon Valley, our company is woman-owned and managed. We enjoy long-standing relationships with many researchers who have used our products for decades, bringing the continuity of List’s products along with them as they move up to new career opportunities.
Full Range of Contract Manufacturing Services
In addition to our catalog products, we offer a full complement of professional services, including: GMP Contract Manufacturing, Production of Live Biotherapeutics, Contract Research, Formulation/Lyophilization and Navigating both Toxin Compliance, and Regulatory Requirements. Our manufacturing and biocontainment experience, and our well-established record of working with partners to successfully bring products to market makes us a great service provider to companies of all sizes.
Full cGMP Facility
List Labs offers a full cGMP facility, and labs designed to meet the most exacting requirements including biocontainment. See our equipment list here. Our scientists are experts at working with pharma, start ups, government and entrepreneurs to further their research, to produce API , and to perform testing. We extend our clients’ capabilities!
Start Your Partnership with List Labs Today!
If you have a project and you’d like to work with a partner who can work independently or as a member of your team, has their own state of the art lab suite, understands key requirements and navigating regulations implicit in toxin production, then contact us to discuss your needs.
We will be attending BIO2014 in San Diego June 23-26 where we will be meeting with companies who have an interest in our wide range of Professional Services. We are also happy to arrange a meeting and tour at our California office. Just email us.