When selecting AbbVie Contract Manufacturing, you are partnering with a leading developer and manufacturer focused on accelerating and mitigating risks to program timelines and on efficiently fast-tracking your program to completion. AbbVie’s mAb and ADC state-of-the-art facility and expert scientific team are located in Worcester, Massachusetts, where we specialize in treating your product as our own and have demonstrated the capability to optimize success from innovation through commercialization. In addition to our expertise, our customers also benefit from a simplified supply chain as both mAb and conjugation manufacturing are conveniently located at one site.




MONOCLONAL ANTIBODY

CAPABILITIES

  • Pre-clinical to clinical capacity is 300 L, 500 L, 3 KL and 6 KL
  • Commercial capability is 500 L, 1,000 L, 3 KL, 6 KL and 12 KL
  • Able to do both biologics and ADCs together at one site
  • 5 suites
  • Approvals for global markets and comprehensive regulatory expertise
  • Structured planning
  • Capability to handle many projects simultaneously
structure

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
structure

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


 

TYPICAL ADC PROCESS STEPS