Reference Standard – An Essential Investment to Expedite Development Milestones

There seems no end to the needs and activities competing for precious start-up funds throughout drug development. One need that is often overlooked is for the provision of a certified reference standard. This item can be viewed as a ticket to meet many Development milestones, and facilitates the R&D supply chain. A Developer does not have a compendial catalogue of standards available for their novel small molecule candidate drug for purchase, so they must source and ensure certification of their reference standard to support the most critical activities, such as: GMP Release and Stability testing of API and drug product clinical trial materials Execution of GLP toxicology studies Analyses of all clinical samples through Development to Registration   Attributes of the Reference Standard: Consists of only a few 10s of grams of the API drug candidate active substance The standard must be: Well characterized (quality, identity, strength, purity) using both QC control and molecular characterization testing methods to comprise the certification data set. The potency must reflect deductions from 100% for moisture and solvent content, ordinary salts, and chemically-related substances (process impurities, degradants). This also must include specificity with respect to solid state morphology, should multiple solid forms be accessible. Stable; isolated and stored under controlled temperature and humidity conditions with unique lot identification and handling vs. Research or regular production materials to maintain its identity and integrity as a certified standard. The standard can be: A sub-lot isolated from a GMP API production batch, a small Research lab lot, or even a lot made using a different synthetic route. Re-certified after the identified re-testing date for the API...