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GMP Grade vs. Reagent Grade
June 22, 2015
By: douano@listlabs.com
By:
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.
See more about our cGMP production capabilities.
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.
For example….
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.
Learn more about special projects including bulk drug substance & active pharmaceutical ingredient development, we have developed in partnership with our clients or contact us with any further questions or inquiries regarding this or any of our other products and services.
6 responses to “GMP Grade vs. Reagent Grade”
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Is there any difference in terms of purity of the reagent grade and GMP grade?
Thanks for your question! It is possible that the reagent grade product would have different release criteria or looser specifications than GMP material. For example, GMP product will likely have more testing done on it than the reagent grade- such as sterility testing if it is claimed to be sterile. When we develop GMP products we strive to reach the highest purity possible. In some cases, a reagent grade process may have been worked out twenty years ago, the GMP process would be more recently developed and incorporate modern processing techniques which could provide a more highly purified product.
Hello! Is there any difference between GMP grade and clinical grade?
Does the GMP grade product have higher purity than clinical grade?
Hello Maja,
There isn’t a difference between clinical grade material and GMP material.
Material that is appropriate for clinical trial investigations must be produced compliant to the cGMP’s, 21CFR211. GMP products produced at List comply with these requirements. These products are not licensed for commercial use, only investigational use.
If a coating reagent is required for analytical testing(potency assay) of a therapeutic product, what should be the grade of coating reagent? GMP grade or Research grade?
If this is analytical testing for a therapeutic, then the company who is making the therapeutic should have their Quality Department make that determination.