ADC & Bioconjugation

Team member handling highly active compound at contract manufacturing facility

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).

Targeted Delivery Through Conjugation

Antibody-drug conjugation technology uses monoclonal antibodies or other biologics to deliver highly active or potent pharmaceutical ingredients (HPAPIs) to targeted cells. In conjugated form, the HPAPIs exhibits 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.

Simplifying the Pathway to Patients

Our ADC Contract Manufacturing footprint offers integrated solutions for your antibody-drug conjugate. Click here for more information on our comprehensive ADC solutions.

Candidate Selection

Our ADC Express™ pre-clinical conjugation services help accelerate production of development-grade ADC constructs with essential analytical characterization of key quality attributes.

The combination of our extensive bioconjugation expertise and proven platform technology will efficiently turn your antibody and/or linker and payload into an ADC, enable scaling and shorten your path to the clinic.

ADC Express™ features

  • 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
  • ADC concentration
  • Payload density/DAR (drug antibody ratio)
  • Monomer/aggregate content
  • Free residual payload

Technology Expertise

We have the right experience and expertise to support your ADC or bioconjugate project:

  • Development experience with more than 45 different ADC constructs and more than 300 batches
  • GMP experience with more than 25 different ADC constructs and more than 110 batches
  • Random cysteine or lysine conjugation technology
  • Site directed conjugation via engineered mAbs or enzyme catalyzed
  • Non-natural amino acids (NAA)
  • Various payloads - auristatins, PBD, tubulysines, maytansiods and custom toxins
  • Extensive analytical capabilities for characterization, including mass spec
  • Release testing and stability for both bulk drug substance (BDS) and drug product (DP)
  • Personnel and suites dedicated to ADC development, manufacturing, and testing

Dedicated Manufacturing Facilities

Our clinical ADC manufacturing facility was purpose-built for handling HPAPIs, antibodies, linkers and for performing complex conjugation processes in a cGMP suite featuring isolators

and specialized handling equipment.

  • SafeBridge®-certifiation
  • 800 sq-ft footprint including airlocks
  • ISO 8 classified clean room environment
  • Unidirectional personnel flow with entry, de-gown, and exit airlocks
  • Personnel airlocks separate from equipment/material airlocks

Our 10,000 square foot commercial-scale manufacturing facility supports clinical Phase I/II/III and commercial ADCs and features:

  • SafeBridge® certification
  • 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

GMP mAb Production

Our BioReliance® Biodevelopment Center at Martillac, France offers state-of-the-art GMP mAb production. Click here to learn more.

Project Management & Supporting Services

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

The analytical services include development of specifications, risk assessment, implementation of process controls and validated cleaning procedures. We also offer

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

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

Offering you a world of capabilities

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

  • Madison, Wisconsin (HPAPIs)
  • St. Louis, Missouri (ADC & Bioconjugation)
  • Martilliac, France (GMP mAbs)

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