006 Analytical Method Development - Colman Byrne

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation
• 10:27 – Colman’s recommendations for method development and validation plans
• 15:04 – Colman speaks to the commonality of changing methods mid-stream
• 22:01 – Regulatory parameters that exist for analytical method development and validation for drug development
• 35:11 – Other physiochemical properties that can affect method development and the vital role that data plays in the validation process
• 48:32 – Ed, Brian and Meranda thank Colman for joining the show

Tweetable Quotes

“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.”

Relevant Links

Analytical Services

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Colman Byrne on LinkedIn