Crystallization Strategies for API Development and Scale-Up

Crystallization is a vital step in the development and production of small molecule active pharmaceutical ingredients (APIs), playing a pivotal role in defining the purity, stability and manufacturability of APIs.

It has a direct influence on key quality aspects, including purity, polymorphic form, particle size distribution and downstream processability.

This webinar will cover the scientific and engineering principles that regulate crystallization, such as nucleation kinetics, supersaturation control and solid form selection.

Attendees will learn about the strategic selection of solvents, the development of strong crystallization techniques and the challenges of scaling up from lab to plant.

The featured speakers will cover critical tools and methods for monitoring and controlling crystallization, such as Process Analytical Technology (PAT), as well as how to apply Quality by Design (QbD) principles to maintain consistency and regulatory compliance.

This webinar will provide a thorough knowledge of how crystallization decisions made at the bench can affect downstream operations, cost and time to market using real-world case studies and practical examples.

Register for this webinar to learn how crystallization strategies can optimize API development and scale-up.

Keywords: API/Formulation Development, CDMO/CMO, Commercial Manufacturing, Crystallization, Drug Development, Drug Manufacturing, Pharmaceutical Manufacturing, Quality, Regulatory, Small Molecule, Small Molecule Drug