Method development is the foundation of pharmaceutical development quality and repeatability of manufacturing, consistency, and drug product specification requirements. The analytical methods in pharmaceutical drug manufacturing are often to understand the mechanism of drug functionality and delivery in preclinical stages, define the product specifications that match those functionalities, and during the quality control of clinical and commercial manufacturing batches, to ensure the drug produced matches that specification that was developed in the lab, in animal studies, or in an early phase of clinical trials. With analytical methods and testing, several key FDA-required, functional and/or guided specifications and characteristics of drugs are being developed and characterized in the lab and tested systematically during manufacturing. At APURUN, the analytical department will be helping clients in all those stages with preclinical partnerships to characterize and specify those analytical characteristics for drug products to analytical methods development for cGMP manufacturing and Quality Control (QC) testing.
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