Process Solutions: Portfolio Announcement

Merck Launches ADC Express^™ Services to Accelerate Pre-clinical Conjugation Candidate Selection

• Provides rapid production of antibody drug conjugates (ADCs) for best candidate selection
• Established platform technology to reliably scale target molecules
• Reduces time to clinic through comprehensive ADC services from pre-clinical to commercial from a single source

October 8, 2019^th

Merck today introduced its ADC Express^™ services for the rapid production of ADCs, which can reduce the time needed to produce development grade constructs for target molecule identification. With more than 70 percent of ADC projects outsourced to CDMOs, this crucial and streamlined service enhances Merck’s offering of process development, analytical development, testing services and manufacturing or supply of linkers, cytotoxins/payloads, and conjugates.

Merck is committed to working with ADC innovators to speed the delivery of potential new cancer treatments to patients. The company has been at the forefront of ADC manufacturing for the last decade and is one of the few CDMOs offering pre-clinical ADC development and other development and GMP services globally.

Merck’s established platform technology can efficiently turn an antibody, linker, and payload into an ADC. The company offers a platform approach to ADC constructs and bioconjugation, resulting in increased flexibility and speed.

ADC Express^™ services include:

• 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) and monomer/aggregate content and free residual payload

For companies that have a rich pipeline of monoclonal antibodies (mAbs) and want to enter the ADC space, Merck’s ADC Express ^™ services allow them to obtain ADCs without having to invest in potent handling capabilities. Companies can either bring their own linker technology or procure a linker payload from Merck.

Traditionally, several CDMOs across the globe were involved in the development and production of ADC programs. Merck’s comprehensive ADC service portfolio combines the crucial steps of drug development and production: mAb solutions, linker, payload, and the final conjugation — all from a single source.

Merck has more than 35 years’ experience handling biological molecules and small molecules (including highly active or potent molecules), performing conjugation and complex analytical testing and manufacturing, reducing complexity for customers.