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.

mAbconjugation

   

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 AND 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 AND 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
INTRODUCTION TO ADCs
  • ADCs are antibodies designed to harness the targeting ability of monoclonal antibodies
    by linking them to cell-killing agents. They are composed of:
    1. Highly selective monoclonal antibody for a tumor-associated antigen
    2. Potent cytotoxic agent (toxin) designed to induce target cell death
    3. Linker that releases the toxin in target cells
  • Unlike chemotherapy, ADCs are intended to:
    1. Target and kill only cancer cells and spare healthy cells
drug_linker

  

TYPICAL ADC PROCESS STEPS
 

process_flow