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Antibody Drug Conjugates

Antibody Drug Conjugates (ADCs) represent an emerging targeting technology that incorporates selective protein/receptor-binding monoclonal antibodies combined with a linker-payload to target and selectively kill diseased cells (i.e., cancer) without negatively impacting other areas of the body.

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Improving Treatment Options & Quality of Life

Saving lives through cutting edge technology & operational know-how.

AbbVie CMO is one of only a select few with expertise in late stage scaleup and ADC contract manufacturing, coordinating either individual, or all collective elements of the complex ADC supply chain - from antibody intermediate to conjugation and final drug product fill finish, AbbVie has the facilities and expertise to help clients succeed in advancing lead ADC drug candidates.

Working with AbbVie Contract Manufacturing means partnering with a proven innovator and market leader focused on advancing your development program to BLA and market success. We have extensive know-how and expertise in the most common types of linker-payload conjugation with a robust (ADC) supply chain planning process.

Our global science and technology team and state-of-the-art facilities can help streamline your production processes and ensure successful scale-up. AbbVie leverages a proven global quality and operational network to mitigate risk and ensure successful BLA and supply chain assurance.

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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

 

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

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 = ADC

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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