The support of an experienced CDMO is critical to overcoming complexity when working with a highly potent active pharmaceutical ingredient (HPAPI) and when solving solubility challenges.
By transitioning to alternative solvents or leveraging process aids, the volumes of solvent can be significantly reduced, and the challenges associated with the use of these chemicals can be addressed, helping create a greener footprint.
In a recent webinar, experts discussed the process that Lonza uses to develop a spray-dried powder formulation and scale that formulation from early feasibility studies to commercial manufacturing.
Micronization is an incredibly important step in the process of transitioning a compound from initial discovery into the clinic. Learn more about the key benefits of micronization.
What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.
The 19 flexible suites for jet milling and pin milling at Lonza’s Monteggio facility represent a key part of the company’s particle engineering service offering. With 37 cGMP mills of different sizes and types, and dedicated areas for steroids, HPAPIs and even cryogenic milling, the site is well equipped to support a wide range of customer projects at any point in the development pipeline.