Managing the risks of your Active Pharmaceutical Ingredient (API) strategyDrug development is a risky venture, to say the least. With a proportionally small number of potential leads making it through even to clinical trials, de-risking is an important step in any API strategy. There can be a plethora of routes to taking a drug through the development process, and different options should be considered at different stages, which should be based on existing data. During planning, an assessment should be made into the suspected risks associated with each route taken, with a view to account for or subvert them when the time comes.
Failure Made Effects Analysis
One method of API route-planning and product risk identification is Failure Made Effects Analysis (FMEA). A useful tool, FMEA is a step-by-step approach that allows for the identification of all possible failures in your API development program, prioritizing them based on a series of parameters (including how serious their consequences are, how frequently they may occur, and how easily they can addressed). The process itself involves the assembly of a team that portrays a range of expertise regarding the process to hand, and the filling in of an FMEA form that can stratify risks that may be faced. It can sound like a lot of bother, but these measures should be considered so as to avoid paying for neglecting them in the long run. FMEA use is on the increase in pharma, as pre-planning your route in this way is advisable in that it helps broaden scientific understanding and define acceptability ranges.
As part of the de-risking procedure, how your API program will scale-up as the drug development program progresses should be considered. Not all raw materials will be scalable. There may be associated cost or health and safety implications that may scupper attempts to up-scale particular raw materials that mean production synthesis can suffer. Available data can be used in order to ascertain which raw materials will be scalable, and as ever, planning is key. It is easy to underestimate the significance the choice of raw material grade used for excipients can have when in early stages of drug development. Ensuring the material grades are the same can help rule out material interactions and differences when troubleshooting.
Scalability of raw materials
Throughout pharmaceutical manufacturing process, lot-to-lot variability of raw materials can have adverse effects on drug quality and consistency. As part of de-risking and forward planning, the implementation of novel process optimization strategies may be required in order to help reduce raw material variability.
Managing your API risks early can be a vital step to the whole drug development program. Improving the reliability and cost efficiencies can greatly reduce avoidable costs and time delays – and can increase the value of your data package to boot. In addition, this level of strategizing can help to reduce the timeframe of the drug development program, which in itself will work to reduce running costs and release funds if investments are based on the meeting of particular milestones throughout the process. Some of the examples mentioned in this blog entry can be considered food for thought, but there is a vast array of factors that should be taken into consideration when de-risking your API strategy. Minimize risk, maximize success!