CMC006 - Analytical Method Development - Colman Byrne

🎙️ Full audio, including show notes & full transcription: https://dsinpharmatics.com/ep6 🍏 Subscribe on Apple Podcasts: https://dsinpharmatics.com/apple 🎧 Subscribe on Spotify: https://dsinpharmatics.com/spotify 🎤 Subscribe on Google Podcasts: https://dsinpharmatics.com/google ▶️ Twitter:   / dsinpharmatics   ▶️ LinkedIn:   / 238776   ▶️ Instagram:   / dsinpharmatics   ————————— 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. ————————— TAKEAWAYS: ————————— 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 ————————— ABOUT CMC Live ————————— FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.