Analytical Method Development with Colman Byrne
Pharmaceutical Regulations in CMC with Dr. Catherine Bernard
August 28, 2020
Selecting a Contract Manufacturing Organization (CMO) with ‘Super’ Les Mintzmyer
September 11, 2020
Episode Summary
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.
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… Click To Tweet 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… Click To Tweet 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… Click To Tweet 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… Click To Tweet 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… Click To Tweet 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… Click To TweetLinks Mentioned
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