Everyone likes to claim they offer fast turnaround times, but clients often come to KCAS having been burned by the lack of timeliness on their Discovery projects. At KCAS, we incorporate our clients’ priorities at the top of our priorities. We have put together a Discovery team with decades of experience – and they are dedicated to quickly solving problems for our Discovery clients. Many of our clients have questions about discovery work and process’, as these are often abbreviated as compared to regulated studies.
Below are a few answers to the questions we are often asked by customers…
What does method feasibility mean to my discovery project?
In case of novel compounds, never studied before, we need a starting point. Often the starting point is to see whether we can select a suitable solvent and modifier to ionize the compound and, from that result, predict the ionization efficiency as a predictor of the expected dynamic range. A positive result is the key to go no-go decision making.
Can you provide me a fully validated method for my discovery project?
Yes. We have different passing criteria that allow researchers design the analysis based on where they are in the drug development pipeline. A fully validated method applies, for example, to when a series of test have been carried out and the molecule is highly likely that will be selected to go forward for the next stage. On the other hand, we will design the analytical work anyway that our clients want. What we propose as typical is just a suggestion.
What does it means when you say method qualification?
It means that we can extract the entire range of the dynamic range from matrix and pass the acceptance criteria for accuracy and precision, including quality control sample passing criteria.
What does is mean when you say method validation?
In addition to all that is included in the qualification step, validation includes a lot of the variables that could make the method less than robost. For example, a couple of variables we will study are bench top (room temperature) stability and long term matrix stability. We consult with our clients and design a set of tests that will be performed as part of the validation.
How fast can you initiate the method development for my discovery project?
Because we have a dedicated team which focuses on discovery projects only, we can have very rapid timelines. We can develop a method within three to five days from the time that we have received all of the material we need to initiate the project (reference material, internal standard, blank matrix, etc.). Often our clients custom design the method development to match their needs and therefore the time lines can vary in those cases.
Have even more questions? Don’t hesitate to reach out – we are here to help solve your discovery project’s biggest challenges.
For more information about KCAS Discovery Services click here.