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ADC & Bioconjugation CTDMO Services

Handling and dissolution of HPAPI in glove box by operator

ADC & Bioconjugation Services for Targeted Therapies

Antibody-drug conjugates (ADCs) have ignited a new era of targeted cancer therapy. With 15+ years of contract development and manufacturing experience, Millipore® CTDMO Services offers leading expertise in the conjugation of drug linkers to monoclonal antibodies (mAbs) with facilities specialized for handling highly potent compounds.

ADC technology uses mAbs or other biologics to deliver highly potent active pharmaceutical ingredients (HPAPIs) to targeted cells. In conjugated form, the HPAPIs exhibit more selective therapeutic activity, sparing non-target cells from many of the toxic effects and improving the safety profile. Our clients are quickly adapting these complex technologies and employing them to develop new oncology and non-oncology products that are more targeted and safer.

Today, novel bioconjugates also feature diverse payloads (e.g., oligonucleotides, radionuclides, targeted small molecules, and degraders) and antibody formats (e.g., bispecifics, fragments) to serve diverse applications and indications.

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Our Track Record

#1

We were the first commercially approved ADC manufacturer in North America

100+

Different constructs developed

60+

INDs enabled

240+

GMP drug substance batches released since 2008

100%

Scalable single-use technology in our manufacturing template


PROCESS DEVELOPMENT

With Millipore® CTDMO Services we offer a vast bioconjugation experience with diverse components: novel antibody formats, solubilizers, linkers, and both cytotoxic and non-traditional payload classes.

Analytical Development

With Millipore® CTDMO Services we offer:

  • QC testing of in-process materials
  • Stability Programs for our bulk drug substance (BDS) and drug product (DP)
  • Release testing of BDS and DP
  • Analytical instrumentation, including: MS, HPLC, iCE/IEF, CGE, ELISA, UV, NMR, IR, SPR

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ADC Express™ Services

Our extensive bioconjugation expertise shortens the path to the clinic through rapid production of development-grade ADC construct libraries with antibody and/or linkers and payloads of choice for preclinical lead candidate selection.

  • Mini-prep scale: 10–20 mg ADC construct ± column purification
  • Medium-prep scale: up to 100 mg ADC ± column purification
  • Certificate of testing with key quality attributes

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A Global FootPrint

A Global Footprint

We are a single organization with a global network to deliver CTDMO services across all stages of the molecule value chain.

Martillac, France
Martillac, France

Biopharma development and manufacturing facility for production of mAbs with 25+ years of GMP experience. Including pilot, and GMP capabilities.

Madison & Verona, Wisconsin (HPAPIs)
Madison & Verona, United States (HPAPIs)

Our API manufacturing site and SafeBridge® certified facility. This 70,000 sq-foot facility builds upon our decades of high potency expertise and makes us one of the largest single-digit nanogram OEL CTDMO providers in the world.

Rockville, MD
Rockville, United States

Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. 

Scientist at drawing board
St. Louis, United States (ADC & Bioconjugation)

Our ADC & Bioconjugation Center of Excellence offers ADC and Bioconjugation capabilities from pre-clinical development to commercial manufacturing. 


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