Avoiding analytical disasters in developing an API strategy
Avoiding common analytical disasters in developing your API strategy during drug development
Few, if any, drug development programs are seen through without hiccoughs or minor errors. Any anomalies or discrepancies that arise throughout the API development process should be very carefully analyzed - nomatter how insignificant they may appear. Any issue has the potential to snowball in a development program assensitive as bringing a drug candidate to the market, and therefore there is a real value in understanding when to stop and assess potential disasters before they get out of control.
Not having the correct analytical method Developing an API strategy is not without its associated risks, and there are a number of pitfalls that can occur on the way. Working with an inappropriate analytical method is one sure fire way on stumbling upon one of these pitfalls. Using screening as an example – High Performance Liquid Chromatography (HPLC) can help determine the purity of your API depending on the polarity of the compound – but steps must be taken to ensure all of the known and unknown purities. The de-risking methods conducted should be appropriate to the phase of the drug development program is currently in. Phase I de-risking methods will be much more general in principle owing to the earlier stage the drug is in, compared to de-risking methods used at phase III, which are more likely to be based on quality by design principles.
Not using appropriate instruments Using inappropriate instrumentation can lead you into trouble equally easily. Using the same example of having a polar compound, having no chromatograph or one of poor quality can be a result of analysis with a generic HPLC column. The use of a charged aerosol detector would have been more advisable in this instance, as they are able to measure a wide range of analyte based on their charge in direct proportion to analyte concentration. Knowing the instrumentation and equipment that is best suited to your endeavors can seriously increase the quality of your data package and analytic method. So the question remains, how best to overcome these challenges?
Overcoming these issues A theme in science; collaboration is key. Working with the process development team involved with the program is important, and they should be reported to. Often companies will have opted to outsource their API strategy. In this instance, active collaboration with the CRO you are in partnership with is key, so as to properly strategize disaster avoidance programs. This way of working can help you to avoid potential disasters and manage the risk of failure as you effectively develop a single method that manages API, drug product, and clinical testing – this helps to minimize the risk of errors and create a data package of high value that is transferable. After all, taking a drug lead from initial lead through to clinical trials is a very costly procedure financially, and you want to ensure that there is as little expenditure as possible in areas where it can be avoided.