High potency APIs

Do you require high potency API manufacturing services? At Cambrex, we are here to meet your supply needs.

We have been reliably developing and manufacturing high potency APIs and compounds for years, including:

  • Immunosuppressants
  • Cytostatics/protein kinase inhibitors
  • Ultra-potent cytotoxic drug substance
  • Drug linkers
  • PEG and cyclodextrin polymeric conjugations
  • Drug product intermediates
  • Warheads/toxins for Antibody Drug Conjugates (ADC)

Cytotoxic, cytostatic & controlled substances

Our cytotoxic, cytostatic and controlled substances capabilities, include the following:

  • Highly regimented safety protocols
  • Controlled access to all areas
  • Best-in-class barrier isolation
  • Process development
  • Scale-up of toxicology lot to commercial quantities in a cGMP environment
  • Development and manufacturing of high potency APIs to < 10ng/m3 OEL
  • Lab scale cGMP manufacturing up to 20L
  • cGMP kilo lab up to 150L
  • cGMP pilot plant
  • Commercial manufacturing up to 16,000L
  • Multi-purpose solids handling suite
  • cGMP micronization facility

Discover more about our high potency API manufacturing services

If you’d like to know more about our high potency API manufacturing services, speak to one of our Cambrex experts – we’re always happy to help.

You’ll also be able to find a wide range of literature on our services if you’d like to know more about high potency APIs or other aspects of our work. Our resources are free to view – take a look.

Resources