As part of our integrated product development services, we provide commercial scale production for all of our product options from a global network of eight sites:

  • Drug substances – intermediates, drug substances based on a full range of chemistry including HPAPI and ADC payloads 
  • Drug-product intermediates – micronized compounds, spray-dried compounds or dispersions, hot-melt extrudates
  • Finished drug products – immediate and modified release tablets, encapsulated multiparticulates or powder-based formulations, liquid-filled hard capsules, softgels

This network facilitates seamless development, scale-up and commercialization of drug products. The option of working with one integrated partner can reduce timelines, complexity, risk and cost versus working with multiple partners.

This on-demand webinar provides an overview of micronization and common scale-up challenges and presents a robust process development strategy that ensures all attributes are maintained for even the most difficult APIs.

View our webinar on-demand

Difficult to micronize drug substance

Commercial manufacturing experience

We have an extensive track record in cGMP manufacture at commercial scale. We currently provide commercial production for more than 200 medicines supplied to patients around the world. Our network has a thorough inspection history with global regulatory authorities including US FDA, MHRA, ANSM, MEB, AEMPS Swiss Medic, PMDA and others.

Phase-appropriate processing is in place to support rapid product and process development from proof-of-concept to commercial production. Our commercial manufacturing capabilities in drug product intermediates and drug products include:

  • Micronized drug substances
  • Spray-dried dispersions
  • Tablets (IR and MR)
  • Multiparticulates
  • Encapsulated multiparticulates or powdered formulations
  • Liquid filled hard capsules
  • Soft gels

Isolation capabilities are in place to drug product intermediates and drug products for HPAPI, cytotoxic and hormone applications. We recognize that every drug program has unique challenges and commercialization requirements. 

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