Major impurities in a drug product should ideally be identified in the early stage of the drug development process, to achieve better control of manufacturing (CMC) in the later stages of compound development. However, those present only at low concentrations are often analyzed significantly later in the process. Finding the structure and source of an impurity is often instrumental in evolving a method for controlling it or eliminating it completely.
Delays in conducting impurity analyses often occur because regulatory deadlines do not require them to be carried out early in the process despite being advantageous. Also, because the analyses take time and much effort, leading to delays until the later part of the clinical development phase.
Averica reduces the burden by drastically cutting out the time and effort required by deploying SFC and a Targeted Isolation™ process. The advantage of SFC is its ability to process the feed material very quickly, at rates which may exceed that of HPLC by more than 20 times.
This permits the main peak due to the pure API to be removed speedily, and thus the sample is enriched, containing all or at least many of the impurities. Individual peaks are then rapidly isolated, taking advantage of the fast pace of method development in SFC.
The early-stage isolation and characterization of an impurity that is made possible by this efficient and cost-effective technique may provide more chances to refine the material delivered for clinical trials, thus improving the definition and granularity when CMC filings are made, and reducing the risk signifcantly in the late-stage trials.
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