Good Laboratory Practice (GLP) Services

GLP applies to studies in non-human animals and their results.  The US Federal Drug Association (FDA) relies on these studies to approve initiation of clinical trials, of new therapies or new populations of patients or clinical indications.  Although evidence of therapeutic benefit is often sought, the main purpose of preclinical is finding toxicities that may apply to humans.  Often, preclinical studies are conducted non-GLP by a pharmaceutical company to obtain preliminary evidence of therapeutic efficacy with minimum toxicity. Studies usually begin in mice because they are cheap, and many scientific physiologies are understood. Human tumors can be grown in suitable strains of mice, allowing for:

1. a) the whole-body environment that affects drug distribution, metabolism and excretion, b) effects of the tumor microenvironment, and
2. c) co-transplant of human effector cells, such as CAR-T or human lymphocytes for bispecific antibody drugs.

Follow up studies are often conducted in monkey or non-human primates in order to test critical issues in an animal species close to humans because:

1. a) the desired target of the drug may have a low or non-binding issue due to the evolutionally distant species,
2. b) the drug may be metabolized differently (and inactivated or made more toxic),
3. c) the drug may be more immunogenic in a distant species.

Good Clinical Practice (GCP) governs clinical trials involving human subjects.  It is similar to GLP scientifically and in Quality Assurance. Key differences are GCP is designed to protect the rights and is more focused on ethical considerations and the scientific validity of clinical trials. While both have safety protocols, GCP places a stronger emphasis on reporting adverse events in human subjects.