Access to relevant physicochemical data is a known enabler of rapid pharmaceutical product development. Many APIs show poor solubility and bioavailability. Knowledge of the formulation and API microstructure is therefore critical to ensure effective product development. Within this, API particle size analysis is well-established as part of the characterization toolbox.
But how do you know if your measurement of particle size is accurate enough? Indeed, what is the ‘true’ value for the particle size of an API or excipient which should be used to fine-tune preclinical development and set product specifications? Should you even try to define this?
In this webinar, John Gamble, Principal Scientist at Bristol Myers Squibb, and Paul Kippax, Sector Director at Malvern Panalytical, argue that accuracy of particle size measurement is not a definable characteristic. Instead, they propose that you should seek to define the ‘appropriateness’ of a measurement, in line with the critical quality attributes (CQA) of the material being characterized.
Join us to explore:
- Why particle size analysis should prioritize appropriateness over accuracy
- What this means for laser diffraction method development
- How to implement image-based particle characterization approaches
- Strategies for integrating these approaches into your workflow
John Gamble is Principal Scientist within the Material Sciences group at Bristol-Myers Squibb, where he applies his experience in material science, gained over 15 years of research within the pharmaceutical industry, to understand the impact of processing conditions on the properties of pharmaceutical formulations and processes. He is a keen advocate of the application of image-based particle characterization techniques in the pharmaceutical development environment and has authored a number of publications in this area. A topic of current interest is the characterization of individual components within multi-component blends to track the impact of unit processes on particle size and shape.
Paul Kippax is Pharmaceutical and Food Sector Director at Malvern Panalytical, leading a team responsible for business development and marketing. He has a degree in chemistry and a Ph.D. in colloid science, both obtained at the University of Nottingham. He has spent the past 23 years developing an in-depth understanding of material characterization techniques and their application in solving pharmaceutical industry challenges. A keen believer in the power of collaboration in enabling innovation, he moved into the Pharmaceutical and Food sector team in order to develop closer customer relationships focused on applying analytics to enable innovative product development.
Who should attend?
- Scientists working in pre-clinical development or process optimization.
- Process engineers and scientists working on the manufacture of drug products.
- Developers considering API and formulation selection
What will you learn?
- Understanding what accuracy means for particle size analysis
- Determine how considering appropriateness instead of fundamental accuracy can aid technique and method selection.
- What this means for laser diffraction method development.
- How to implement image-based particle characterization approaches.
- Strategies for integrating these approaches into your workflow.