Jeffrey Kiplinger, President and Founder of Averica, answers questions about the role impurity isolation can play for start-ups.
How can looking at impurity isolation at the beginning of drug development benefit a start-up?
Startup companies focus on moving one or two related programs forward as fast as possible. Each compound picks up value as more and more useful information is gathered. A start up company’s goal is to use that information to figure out how to monetize a compound as soon as possible.
Impurity isolation works to identify and understand impurities, leading to: improved scale-up chemistry, development of a better GMP process, improvement of the quality of clinical trials material, enhanced definition and granularity in CMC filings, and furthered de-risking of late stage studies. Companies that initiated impurity work early have the opportunity to resolve problems quickly, adding value for the money you spend.
How does the information you get from chemical analysis and assays add value?
So you have to make your choices according to what gives you the value you want. With benchmark driven programs your valuation points have been pre-calculated. Let’s say your benchmark is to get to IND, then having a bunch of uncharacterized 5% impurities in your compound will be a problem for approval of Phase I studies. You should also know if those impurities are containable, do not have an ongoing fast degradation process, and are not toxic.
Does scalable separation factor into this process?
Yes, you need supply of material to do any kind of profiling assay. A small supply can assay one property, but a much larger supply is needed for toxicity studies. Being able to access that supply when you need it is the key.
You could start off and spend a lot of money to get a kilo clean. Then you could have plenty of supply to do all your work. However, that could be unwise if you don’t know anything else about the compound. If it fails, you have wasted a lot of money and time. Also, you can’t get anything done until cleaning the kilo of material is finished.
For more information here are five tips on controlling scope creep in impurity isolation projects: 5 Ways to Prevent Impurity Isolation Scope Creep