In addition to MarinBio’s Research Level (non-GLP & non-GMP) work, Marin Biologic Laboratories performs scientific work under Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) standards. GLP and GMP are terms used by the FDA and regulatory agencies that define laboratory work that specifically adheres to rigorous laboratory research or manufacturing guidelines. MarinBio employs a quality system of management controls to ensure clients with the uniformity, consistency, reliability, reproducibility, quality and integrity of the MarinBio study.
GLP studies are often employed in non-human studies, such as Pharmacokinetics (PK) that quantitatively measures drug concentrations and drug clearances in the body, Pharmacodynamics (PD) that detects the pharmacologic effects of a drug and Anti-Drug-Antibody (ADA) studies that measure host antibody responses to a client test 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 human studies and non-human toxicology studies. The documentation and calibration regulations for GLP and GMP studies far surpass that of research level studies.
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The application of GLP and GMP practices into MarinBio’s typical laboratory practices creates an environment that is consistently of the highest quality and which is fully documented. The value of these GLP or GMP practices is to have continuous auditable evidence that every measure has been taken through the supply chain and into the final procedures to ensure the authentic and accurate representation of the study.
Both GLP and GMP laboratory and manufacturing practices require significant additional investments in equipment maintenance and calibration, training, documentation and procedures to achieve GLP and GMP quality. These GLP and GMP laboratory and manufacturing practices also add to the time required to meet the extensive documentation needed for each of the many small steps to satisfy the GLP and GMP requirements.
Frequently, a client study starts out at our research level contract (non-GLP or non-GMP) for screening compounds, showing proof-of-principle, mechanism of action, or developing a supporting assay. However, as the client therapeutic drug moves along the developmental path, it may require GLP or GMP quality studies to support a later stage IND or BLA application. With this in mind, MarinBio experts will communicate to you decisions during this early stage to select appropriate vendors, identify critical reagents, secure a stock of these reagents that will support your assays for the necessary years of analyzing lot-to-lot variability, stability studies, etc. We are your expert professionals and think of us as your scientists.
MarinBio conducts a broad spectrum of contract work using GLP & GMP standardized R&D & Manufacturing procedures, reporting, standards and equipment. Our entire MarinBio team is trained to think and work interchangeably in Research Level non-GLP and non-GMP contract programs, as well as moving the project to the GLP-GMP level. Additionally, MarinBio scientists can take an already developed project and validate or qualify it to a GLP-GMP level. This level of contract research awareness brings the appropriately required consistent and deliberate approach to all the work we do in all project levels.