Key takeaways from our API Scale-up Strategies roundtable

Analytical tools can help process development scientists and engineers understand and optimize the solid-state characterization of drug substances, which is crucial for ensuring API quality during scale-up. Our new webinar series, "API Scale-up Strategies," ? explores various analytical solutions that can be applied to predict the efficacy and maintain the quality of drug substances during the scale-up process. ??

This four-part series kicked off with a round table discussion with experts Dr Natalia Dadivanyan , Dr. Anne Virden , Dr. Kuo-Chih Shih , and Dr. Lieven Kempenaers, Ph.D. You’ll find a recap of the key points below ???

1. Particle size and shape?

Dr. Anne Virden emphasized the importance of particle size and shape in API quality. Techniques like laser diffraction and automated image analysis, such as the Morphologi 4, provide critical data that influence bioavailability and processability.?

2. Crystallization and polymorphism?

Dr. Kuo-Chih Shih highlighted the role of XRD in addressing crystallization challenges and polymorphism. Tools like Aeris Compact XRD help identify and quantify polymorphic impurities and measure crystallinity, crucial for ensuring drug efficacy.?

3. Ensuring purity?

Dr. Lieven Kempenaers discussed the benefits of XRF for detecting impurities. The innovative Revontium compact XRF system offers fast, non-destructive screening, enhancing the drug development process by ensuring elemental purity.? ?

Q&A session??

We concluded the webinar with a Q&A session, where the panel addressed questions from the audience on various topics, including the use of laser diffraction for assessing particle shape, the detection limits of XRD, the use of XRF for analyzing byproducts, and the importance of measurements during scale-up.??

Upcoming webinars?

Interested in learning more? Don't miss our upcoming webinars, available live and on-demand:?

• Navigating Challenges in API Solid-State Analysis - June 12, 2024 - Watch the recordings here ??https://www2.malvernpanalytical.com/l/345261/2024-06-24/8pm2s7
• Perfecting Particle Size and Shape - June 27, 2024- Register or view the recordings here ??https://www2.malvernpanalytical.com/l/345261/2024-06-24/8pm354

• Controlling Polymorphism & Crystallization - July 16, 2024 - Register or view the recordings here ??https://www2.malvernpanalytical.com/l/345261/2024-06-24/8pm397
• Eliminating Contaminants Through Solid-State Analysis - July 25, 2024, Register or view the recordings here ??https://www2.malvernpanalytical.com/l/345261/2024-06-24/8pm3gf

Join us to gain deeper insights into solid-state characterization and improve your API development process!?

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