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

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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)

DM1 is a GMP quality payload for your drug conjugate programs
100 mg samples available free of charge
HPLC Purity > 97%
Maytansinoid Products for Your Drug Conjugate Program

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)

PBDCore™ Intermediate contains the active structural components and handles of PBDs, giving you the flexibility to make most PBD payloads
10 g samples available free of charge
HPLC Purity >95%
Simplify Your Synthesis with ADCore Payload Intermediates

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

Use of Payload Core Compounds to Accelerate ADC Clinical Development Timelines
In this whitepaper, we explore the complexities of developing ADCs and compare the conventional approach to starting with the payload core compounds.
Overcoming the Solubility Challenges of Antibody-Drug Conjugates
In this flyer, we learn how to increase solubility of ADCs when incorporated into the linker-payload construct.

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:

Madison, Wisconsin, USA: cGMP contract manufacturing services for HPAPIs, advanced intermediates and linker-payloads
St. Louis, Missouri, USA: cGMP Center of Excellence for ADC and Bioconjugation, Bio-Organics
Sheboygan, Wisconsin, USA: non-GMP critical raw materials integral for API synthesis programs