MilliporeSigma

Highly Potent APIs

High Potent API Manufacturing

With over 30 years of experience in the production of highly potent active pharmaceutical ingredients (HPAPIs), we are an industry leader with the expertise needed to tackle the unique handling challenges of these powerful compounds. As your CTDMO partner, we offer:

  • Range of scale and handling capabilities down to single-digit nanogram containment
  • SafeBridge® certified facilities with SafeBridge® Industry Leadership in HPAPI handling certification
  • A comprehensive portfolio of payload and advanced payload intermediate products to accelerate your drug development
  • Strong quality and regulatory support from pre-clinical to commercial programs
  • Reliable, global supply chain network for high quality raw material sourcing
  • Seamless integration with downstream ADC/bioconjugation service offer

Safety

As one of the first facilities to receive SafeBridge® certification, we have been industry leaders in safe handling of Highly Potent APIs (HPAPIs) for over 30 years. To continue to build upon that pioneering spirit, we have invested heavily in our new Verona, Wisconsin HPAPI facility which boasts 6 new kilo labs with single-digit nanogram occupational exposure limit (OEL) containment. This innovative facility design raises the global standard for the safe handling of the industry’s most potent APIs.

Drug Development Acceleration Products

Accelerate your drug development efforts with our comprehensive product line of payloads and advanced payload intermediates. These products add value to your program by reducing development costs, decreasing supply chain complexity, and increasing speed of synthesis through reduction of required reaction steps – together accelerating your speed to clinic. Discover our product portfolio:

DM1 (Mertansine Payload)

MAYCore™ (Advanced Maytansine Intermediate)

  • MAYCore™ is an advanced intermediate that simplifies maytansine payload synthesis
  • Proprietary maytansinoid synthesis can be modified to meet your specific linker-payload needs
  • 3 g samples available free of charge
  • HPLC Purity >95%

DOLCore™ (Advanced Dolastatin Intermediate)

  • DOLCore™ is an advanced intermediate to simplify the synthesis of dolastatin-10 payloads
  • Reduce the number of synthesis steps from 15-20 to four or fewer
  • 5 g samples available free of charge
  • HPLC Purity >98%

PBDCore™ (Advanced PBD Intermediate)

Comprehensive Service Offer

From sourcing and/or production of custom raw materials to downstream ADC bioconjugation, we offer integrated expertise and support for your HPAPI program. From pre-clinical to commercial, we provide a streamlined experience throughout development, manufacturing, and testing. Learn more about:

  • ADC Express™ Pre-clinical Conjugation Services for the Best Candidate Selection
  • Comprehensive ADC and Bioconjugation Solutions

Request Information About Our CTDMO Services for High Potent APIs

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Related Technical Resources


INTEGRATED SUPPLY CHAIN FOR HPAPIS AND ADCS

The global footprint of our API contract manufacturing services assures you wide-ranging regulatory and supply expertise, easily accessed through a single trusted partner.

Our API Contract Manufacturing Facility Locations:    





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