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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