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Antibody Drug Conjugates

Antibody Drug Conjugates (ADC) are an emerging immunotherapy that use tumor-seeking monoclonal antibodies linked with potent cytotoxic agents (toxin) to target and kill only cancer cells while sparing healthy cells.

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Stone-Cold Cancer Killers

Saving lives on the cutting edge of oncology.

AbbVie CMO is one of a few global CMOs with the expertise in ADC contract manufacturing to streamline production processes and supply chains and coordinate all facets of your ADC production, from the monoclonal antibodies and conjugation with the linker-toxin.

Working with AbbVie Contract Manufacturing means partnering with a proven innovator and market leader who is focused on fast-tracking your drug development program to completion and facilitating sustained market success. We are one of only a few CMOs globally with the capabilities and experience to develop and deliver the entire comprehensive antibody drug conjugates (ADCs) supply chain.

Our state-of-the-art facility and expert team in Worcester, Massachusetts, are able to streamline your production processes and supply chain. Leveraging program stability, a unified quality and operational network to coordinate all facets of ADC production including monoclonal antibody (mAb), linker-toxin and conjugation across our global network.

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Monoclonal Antibody

mAb

 
  • Global antibody manufacturing with over 85,000 L capacity
  • cGMP scale 1,000 L to 12,000 L
  • Full pharmaceutical support

Process Development

 
  • Offer full development package
    • Cell line development
    • Analytical development
    • Late clinical transfer
    • PPQ efforts to post-commercial offering
  • Cell culture process development
  • Purification process development
  • Media development and optimization
  • Analytical method development
  • Extended product characterization
  • Viral clearance studies
  • Provide technical expertise and assistance from cell line development to commercialization
    • Process transfer/development method (analytical, scale-up, etc.)
    • Process validation and mapping
    • Process data trending
    • Continuous process verification
  • Quality assurance
  • Quality control
  • Project management

 

 

Analytical Development, Release & Stability

 
  • HPLC (SEC, IEX, affinity, reverse phase)
  • Host-cell protein
  • Electrophoresis (CE, IEF, SDS-PAGE)
  • ELISA
  • Peptide structure determination (LC, MS)
  • Oligosaccharide analysis
  • DNA quantification (threshold)
  • Spectrophotometry (FT-IR, US VIS)
  • Bioburden/endotoxin

Conjugation

Capabilities

 
  • Designated and tested facility able to handle compounds with OEL down to < 10 ng/m3 containment
  • Handle up to category 5 compounds: auristatin, PBD, and calicheamicin
  • Process validation
  • 2.5 L to 32 L columns
  • cGMP conjugation for clinical and commercial
  • Preparation of GLP tox material
  • Single-use TFF unit with membrane capacity up to 2 m2
  • Reactor volume 30 L to 500 L stainless steel and single use
  • Single-use chromatography columns used on Akta skid

Process Development

 
  • Conjugation scale for process development is milligram to gram scale
  • Formulation development
  • UF/DF development
  • Manufacture material for pre-clinical studies including analytical characterization
  • Chromatography methods development

Analytical Development, Release & Stability

 
  • Onsite quality and testing
  • R&D onsite testing
  • UV/VIS
  • MALS/IR
  • CE, icIEF
  • CE-SDS (Beckman), mCE-SDS (Perkins Elmer)
  • HPLC, UPLC, LC/MS
  • LAL
  • ELISA
  • Environmental/bioburden testing
  • HIC for DAR

mAb + Conjugation = Antibodies

Typical ADC Process Steps

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.

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