API Scale-up Strategies: Crystallization Command

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Are you involved in drug substance crystallization? Are you striving to optimization the crystallization processes and their yields? Does your success rely on delivering the right polymorph and the elimination of non-efficacious forms? Do you need to establish whether contaminations by other crystalline forms can be detected - even when present at very low concentrations?


Then we have a perfect solution for you: meet Aeris – the first compact XRD system on the market! Aeris offers a unique combination of features that make solid-state analysis quick and efficient:


• It’s easy-to-use: plug-and-play simplicity means you don’t need a crystallographic background

• It delivers high-quality data fast: within 5 minutes you can obtain a full pattern to fingerprint your API

• High sensitivity for low detection limits: with Aeris you can improve you detection limits and be assured of the quality of your products


Do you doubt homogeneity of your materials? Do you have evidence of sample inconsistency? Then you need to explore the benefits of Morphologically-Directed Raman Spectroscopy. This technology combines analytical imaging with Raman Spectroscopy in the Morphologi 4-ID. This instrument allows you to:


• Produce statistically significant particle shape information

• Determine the polymorphic form of each particle

• Link particle shape to polymorphic form

発表者

  • Dr. Anne Virden - Product Manager, Malvern Panalytical
  • Dr. Kuo-Chih Shih - Senior Field Applications Scientist Pharmaceutical Sciences, Malvern Panalytical

詳細

Who should attend? 

  • Pharmaceutical scientists working in process development and process optimization
  • Pharmaceutical scientists in method development at all stages of the pharmaceutical development pipeline
  • Anyone working on crystallization optimization


What will you learn? 

  • Learn how applying a multi-technique approach provides the most robust mechanism for developing and optimizing your processes
  • Understand how to detect even the slightest changes that can put the performance of your drug substance at risk
  • Discover easy to use techniques for solid form validation and impurities detection