Before API synthesis begins

Steps before undertaking Active Pharmaceutical Ingredient (API) synthesisDrug development begins with the synthesis of the API itself, so it will come as no surprise that this stage is critical to any development program. Ensuring prompt API delivery is a good step in the right direction of a successful drug development project. Timelines for drug development programs are often based on cash balance and the need to meet the next milestone that will bring in another wave of investment. Late API delivery can result in missing important milestones, such as filing an investigational new drug application, which could have significant financial consequences. 

Before undertaking API development, it is well worth considering the level of development undertaken on the molecule of interest so far and goals for the project going forward. In terms of developing your API strategy, there are a number of topics that need ticking off your agenda to enable you to keep on track. Properly ascertaining your long term and short term goals can help isolate your next move(s). For instance, it is worth considering whether you plan on creating a good quality data package with a view to sell on the API, or are you taking the lead compound all the way through to long-term development and clinical trials?

As a starting point, it is recommended that you take a step back and ask yourself what stage of the project you are actually in. Considering whether you have an early phase molecule in small quantity, or if you are in phase III of clinical trials can and probably will alter your approach. Does your molecule need refinement, or just a scale-up of production? Considerations into the scale of the project up to this point should be made, and whether the route you have decided to take is feasible for larger scale development. After all, overheads are going to increase, and you need to make sure that your company can meet the production goals you set for yourself.

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Profiling your drug

Further to this, properly profiling your drug, including considering its toxicology, will have an impact on the facilities required and controls to be put in place in order to meet safety and hygiene standards. Development of the API may require the use of substances that are toxic in nature, meaning different aspects of the development program will need rigorous planning to ensure health and safety measures are met. Furthermore, working out what analytical methods are currently available to you for API development is critical, as it is important in ascertaining whether the method is phase appropriate and scalable – and checking whether or not the method can be validated is recommended too!

There are a number of topics here that should be addressed in order to facilitate the development of a truly optimized and efficient API program – following these steps can help make the process run more smoothly too. Meticulous planning of your timeline and routes taken is necessary, as each API strategy will have to exhibit a degree of individual identity, depending on the potential drug in hand.  A drug development program may include many things depending on the nature of the molecule in question; small scale laboratory synthesis, chemical process development, QC method development and validation, and thermal hazard & safety features can be common elements. As mentioned, however, different drugs will require different things, and it is worth noting that proper research into some of the topics discussed in this blog cannot be recommended more.

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