DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.
“One of the difficulties is that when you’re starting off with a molecule, you know relatively little about it. And, over the course of the development project, as you go further and further through pre-IND to Phase 1, Phase 3 and eventually into commercialization, you’re constantly learning more and more about the molecule and about what can happen to it under different circumstances.”
“It’s typically less expensive to develop a solid test method than it is to develop a drug substance manufacturing process or to go through and manufacture bunches of batches of drug products. And so, it is really a question of trying to spend the appropriate resources at the appropriate time.”
“Typically, you’re looking at seven different parameters. The first one – one of the more important ones – is specificity, showing that you can, with a particular test procedure, separate out whatever you’re looking to quantitate with that test method.”
“You don’t know and you can’t know everything upfront, right away. You’re always going to find more things out. Ideally, they’re not going to be bad things that you have to do a lot to resolve. But, sometimes, that’s what happens due to situations that are outside your control.”
“You try to minimize the frequency in which you have these unfortunate learning experiences, but sometimes they’re unavoidable. And by focusing your development upfront and looking at the available information and the potential pitfalls, then you can minimize the possibility of having what we call these unfortunate learning experiences that will cost time and money and cause potential delays.”
“A validation of a test method should be a smooth process because you should expect that you know everything that could possibly gone wrong and will have addressed those before you do the validation. A validation is ideally just a rubber stamp to show that you have done, under control conditions, all the work that’s needed to show that your data is accurate and precise and linear.”
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