Biologics_Hero_Gradient2x.png

Services

Monoclonal Antibody Manufacturing & Production Services

AbbVie Contract Manufacturing is a proven mAb CDMO partner with 35+ years of clinical and commercial drug substance manufacturing experience. From cell bank generation through commercial supply, we deliver the technical expertise, regulatory track record and global capacity your monoclonal antibody program requires.

 

Biologics_Hero_Gradient2x.png

Why Partner with AbbVie for Monoclonal Antibody Manufacturing

Monoclonal antibody production demands more than available capacity. It requires a manufacturing partner with deep process expertise, a strong regulatory track record and the operational discipline to deliver consistent quality at every scale.

 

World Class mAb CDMO

AbbVie Contract Manufacturing brings the full capabilities of a global biopharmaceutical leader to your mAb program. As an embedded CDMO within AbbVie Inc., we apply the same rigorous standards, validated processes and quality systems used to manufacture AbbVie's own commercial biologics—including some of the world's most successful monoclonal antibody therapies.

Our monoclonal antibody contract manufacturing services are backed by:

  • Several approved commercial biologics manufactured across our global network

  • 35+ years of clinical and commercial drug substance validated experience

  • 100s of mammalian programs successfully tech transferred

  • 86,000 liters total bioreactor capacity across three cGMP manufacturing sites

  • Consistently ranked among top-performing CMOs in industry surveys

Comprehensive mAb Manufacturing Capabilities

AbbVie offers end-to-end biologics contract manufacturing services designed to accelerate your monoclonal antibody program from first-in-human through commercial launch and lifecycle management.

Process Development & Optimization

Our process development teams deliver upstream and downstream process development, optimization and scale-up services. Capabilities include:

  • Cell culture process development and optimization

  • Purification process development

  • Media development and optimization

  • Analytical method development

  • Extended product characterization

  • Viral clearance studies

cGMP Drug Substance Manufacturing

AbbVie operates cGMP manufacturing with flexible scale options to match your program requirements:

  • 2,000L single-use bioreactors (SUBs) for early clinical and smaller commercial batches

  • 3,000L and 6,000L stainless steel options for mid-scale production

  • 12,000L stainless steel capacity for large-scale commercial manufacturing

Our manufacturing network spans three globally approved sites: Worcester, Massachusetts (ABC), Barceloneta, Puerto Rico (ABL) and Martillac, France (MBM)—providing geographic flexibility and supply chain resilience.

Pre-clinical to commercial mAb manufacturing, from 2,000L to 12,000L batch sizes 

AbbVie offers world-class monoclonal antibody manufacturing in the US, Europe and Singapore.  Capabilities include 2,000L single use bioreactors (SUBs), and 3,000L, 6,000L and 12,000L stainless steel equipment options in various suite configurations. The illustration below offers various examples of our ability to initiate partnership at any stage of your product development, up to and including ongoing commercial supply.

Mammalian Modality Expertise

Beyond traditional monoclonal antibodies, AbbVie Contract Manufacturing has validated experience across complex mammalian modalities:

This breadth of experience means our technical teams understand the unique challenges of complex molecule manufacturing—from expression system optimization through formulation development.

 

Analytical Services & Quality Systems

Every mAb manufacturing program is supported by comprehensive analytical capabilities:

  • HPLC (SEC, IEX, affinity, reverse phase)

  • Host cell protein analysis

  • Electrophoresis (CE, IEF, SDS-PAGE)

  • ELISA

  • Peptide structure determination (LC, MS)

  • Oligosaccharide analysis

  • DNA quantification and identification

  • Spectrophotometry (FT-IR, UV VIS)

  • Bioburden and endotoxin testing

Our quality systems reflect AbbVie's global pharmaceutical standards, with commercial approvals in 180+ countries and a strong track record of successful regulatory inspections.

 

Integrated End-to-End Supply Chain

AbbVie is uniquely positioned to support your extended supply chain from drug substance through drug product. Our aseptic fill-finish capabilities in Sligo, Ireland include state-of-the-art isolator technology for both liquid and lyophilized vial presentations (2R-20R).

For ADC programs, we offer fully integrated manufacturing from antibody intermediate through conjugation and final drug product—all within a single quality and operational network.

 

The AbbVie Partnership Advantage

  • As an embedded CDMO, AbbVie Contract Manufacturing operates differently than stand-alone contract manufacturers:
  • Patient-centered culture: Every project is treated with the same urgency and quality standards as AbbVie's own products

  • Operational leadership: Access to the planning, supply chain and sourcing capabilities that support AbbVie's global commercial portfolio

  • Long-term commitment: 40+ years of sustained investment in contract manufacturing capabilities

  • Strategic partnership: We focus on fewer partners within our core competencies, offering dedicated resources and clear project visibility

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.