Highly Potent APIs
High Potent API Manufacturing
As a seasoned contract manufacturer of highly potent active pharmaceutical ingredients (HPAPIs) with over three decades of experience, we are at the forefront of the industry and possess the expertise required to handle the distinct challenges that come with these powerful compounds. We serve as your capable and reliable CDMO partner, providing you with a range of scale and handling capabilities down to single-digit nanogram containment.
- Our facilities are certified by SafeBridge®, an industry leader in HPAPI handling certification, ensuring the utmost safety and security in all our operations.
- We offer an extensive portfolio of payload and advanced payload intermediate products that can accelerate your drug development.
Our commitment to quality and regulatory standards extends from pre-clinical to commercial programs, and our global supply chain network ensures the highest quality of raw materials sourcing. We seamlessly integrate with downstream ADC/bioconjugation service offers, providing you with end-to-end solutions for your pharmaceutical needs.
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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.
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™ 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™ Intermediate contains the active structural components and handles of PBDs, giving you the flexibility to make most PBD payloads.
- 10g samples available free of charge
- HPLC Purity >95%
Exatecan mesylate is a GMP quality payload for your drug conjugate programs
- 1 g samples available free of charge
- HPLC Purity >97%
Monomethyl auristatin E (MMAE) is a GMP quality payload for your drug conjugate programs
- 1 g samples available free of charge
- HPLC Purity > 97%
- 100 mg samples available free of charge
- HPLC Purity > 97%
INTEGRATED SUPPLY CHAIN FOR HPAPIS AND ADCS
The global footprint of our HPAPI contract manufacturing services assures you wide-ranging regulatory and supply expertise, easily accessed through a single trusted partner.
Our API and HPAPI manufacturing sites are SafeBridge certified. Continued investment and expansion in these facilities build upon our decades of high potency expertise and makes us one of the largest single-digit nanogram OEL CTDMO providers in the world.
GMP contract manufacturing services for ADC and Bioconjugation, and Small Molecule bio-organics.
ISO 9001:2008 certified site meeting customer needs from development to commercial‑scale production of registered starting material.
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.
- Chasing the Nanogram Limit
In this webinar, we discuss the evolution of the high potent API manufacturing industry from 10 µg to single nanogram limits, safety concepts, and how we have met challenges and prepare to move forward.
- ADC Payload Intermediates and virtual HPAPI Site Tour
In this webinar, ADCs and other targeted therapies are opening up a world of exciting opportunities to change the nature of cancer treatment. HPAPIs are a critical element of these therapies.
- How to Accelerate and Enhance ADC Therapies
In this webinar, we discuss the overview of new products and services to accelerate and enhance ADC therapies, such as the ADCore payload, ChetoSensar™, and ADC Express™ service.
Related Videos
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