Comprehensive Service Accelerates Development of ADCs and Reduces Time to Clinic

A new service called ADC Express™services, launched by MilliporeSigma, allows for the rapid production of Antibody-drug Conjugates or ADCs. The service is expected to help reduce the time needed to produce development grade constructs for target molecule identification and accelerate preclinical ‘best’ candidate selection.

The new service was launched at the start of World ADC, the ‘must attend’ industry meeting for anyone involved in the development and manufacturing of ADCs, held October 8 – 11, 2019 in San Diego, CA.

ADCs are ’empowered’ antibodies linked to a highly active or potent pharmaceutical ingredients (HPAPIs) to targeted cells. In a conjugated form, these HPAPIs exhibits more selective therapeutic activity, sparing non-target or healthy cells from  the harmful toxic effects, while improving the safety profile.

ADC Bio
MabPlex
Lonza
 

Traditionally, several Contract Development and Manufacturing Organizations or CDMOs across the globe would be involved in the development and manufacturing of antibody-drug conjugates, making development programs complex and expensive.

However, with more than 35 years of experience in handling biological molecules and small molecules (including HPAPIs), conjugation chemistry and complex analytical testing and manufacturing, reducing complexity for customers as well as being at the forefront of ADC manufacturing for the last decade, MilliporeSigma is one of only a few CDMOs offering a complete range of preclinical and other development services as well as global cGMP focusing on antibody-drug conjugates.

Comprehensive
With more than 70% of all ADC development projects outsourced to CDMOs, rapid development of ADCs is crucial for success. And MilliporeSigma’s new streamlined service, offering enhances process development, analytical development, testing services and manufacturing or supply of linkers, cytotoxins/payloads and conjugates, combines all crucial steps of drug development and production: mAb solutions, linker, payload and the final conjugation, from a single source.

The new platform technology is designed to efficiently turn an antibody, linker and payload into an ADC. This platform approach results in increased flexibility and speed.

MilliporeSigma’s ADC Express™ services includes:

  • Mini-prep scale: 10–20 mg ADC construct ± column purification
  • Medium-prep scale: ~100 mg ADC ± column purification
  • Certificate of testing with key quality attributes, including
    • ADC concentration,
    • Payload density/DAR (drug antibody ratio),
    • Monomer/aggregate content, and
    • Free residual payload

Benefit for development
MilliporeSigma is committed to working with ADC innovators to speed the delivery of potential new cancer treatments to patients. For companies that have a rich pipeline of monoclonal antibodies (mAbs) and want to enter the ADC space, MilliporeSigma’s new ADC Express™ services allows them to obtain ADCs without having to invest in potent handling capabilities. The new service allows companies to either bring their own linker technology or procure a linker-payload from MilliporeSigma.