Antibody drug conjugates CTDMO services

Our ADC & Bioconjugation Offering

With more than 35 years of experience, we are a leading expert in the conjugation of highly active molecules to monoclonal antibodies for the development and manufacture of antibody-drug conjugates (ADCs).

Antibody-drug conjugation technology uses monoclonal antibodies 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. Customers 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.

Contract Manufacturing Inquiry

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Process and Analytical Development

Our comprehensive ADC solutions include analytical and process support throughout all stages of drug development and manufacture:

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

Chetosensar^™ technology

Our ChetoSensar^™ technology can help to improve the solubility of ADCs and provides access to highly hydrophobic novel payloads that might not otherwise be considered.

ADC Express^™ Services

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

Payloads and ADCores

Next to (cGMP) DM 1 - Mertansinoid, we offer a comprehensive product line of advanced intermediates for the most common payload classes aimed at significantly reducing the time, risks, and challenges associated with ADC payload development and manufacturing.

Dolastatins (DOLCore^™)
Pyrrolobenzodiazepines (PBDCore^™)
Maytansinoids (MAYCore^™)

Process Development

Our dedicated experts will listen to you at every step of your process to provide tailored guidance and solutions based on scientific knowledge, quality, and regulatory compliance for all your key milestones, no matter the scale of your operation.

Project Management

From evaluation to execution, our highly skilled and dedicated project managers are responsible for coordinating multi-disciplinary teams, international site activities and timelines:

Dedicated and transparent approach to ensure a positive customer experience
Globally harmonized best practices
Responsive and solution driven
Flexible and collaborative

Manufacturing

The ADC manufacturing facilities were purpose-built for handling HPAPIs, antibodies, linkers and for performing complex conjugation processes in cGMP suites featuring isolators and specialized handling equipment. Our innovative processing templates include single-use technology and advanced PAT for process control.

Production Suite 1 features

SafeBridge^®-Certification
1200 sq-ft footprint including airlocks
EU Grade D room with a Grade C biosafety cabinet
Unidirectional flow (personnel and materials/equipment)
Entry, de-gown, and exit airlocks
Personnel airlocks separate from equipment/material airlocks
Flexible, multi-scale processing requiring chromatography purification

Production Suite 2 features

SafeBridge^®- Certification
10,000 square foot commercial-scale manufacturing facility supports clinical Phase I/II/III and commercial
Unidirectional flow (personnel and materials/equipment)
Rated for flammable use
WFI system
Drug weigh-up room (Grade C)
Isolator for drug-linker weigh up
Single pass air
Sequential airlocks designed for cGMP/containment

Offering you a world of capabilities

The global footprint of our contract manufacturing services assures you of a wide-ranging regulatory and supply expertise, easily accessed through a single trusted partner.

Our Contract Manufacturing Locations

Martillac, France (mAbs)

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

St. Louis, Missouri (ADC & Bioconjugation)

Our ADC & Bioconjugation manufacturing site. We offer more than 35 years of experience as the leading expert in the conjugation of HPAPI to mAbs for ADC manufacture.