In addition to our Research Level work, Marin Biologic meets both Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards whenever necessary. GLP and GMP are terms that define principals intended to ensure safety and quality. GLP refers to assays relating to non-human studies such as Pharmacokinetics (PK) that measures drug concentrations and clearance in the body, Pharmacodynamics (PD) that detects pharmacologic effects of a drug, and Anti-Drug-Antibody (ADA) which measures host antibody responses to a drug. Similar studies on clinical samples follow the same guidelines. GMP refers to the manufacture of drugs intended for human use, including comparability with drug lots used for nonhuman toxicology studies.
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The application of GLP and GMP practices into typical laboratory practices creates an environment in which uniformity, consistency, reliability, reproducibility, quality and integrity of pharmaceuticals are consistent and auditable. The value of these practices is to have continuous auditable evidence that every measure has been taken through the supply chain and in the procedures to ensure the authentic and accurate treatment of the material, equipment and documentation that will ensure public safety as a result.
Both GLP and GMP practices require significant additional investments in equipment maintenance, training, documentation and procedures to achieve the standard we set for both. These practices generally do not add to the experimental time, but, add considerably to the time required to meet the extensive documentation needed for many small steps. Our research level efforts do not need these procedures. At some point moving through the FDA IND through Clinical Trials depending on your specific circumstances your efforts will be required to use GLP and/or GMP as your standard.
We conduct a broad spectrum of work inside the GLP-GMP standards and equipment. Our entire team is trained to think and work interchangeably in Research and GLP-GMP. That level of awareness brings a consistent and deliberate approach to all the work we do in all standards.