White Paper

Challenges In ADC Production - Consolidating Operations Under One Roof

Source: Eurofins
GettyImages-824641956 monoclonal antibody
Credit: Getty Images

Antibody-drug conjugates (ADCs) represent a transformative advancement in oncology therapeutics by combining targeted monoclonal antibodies with potent cytotoxic payloads. However, ADC production poses complex challenges due to the toxicity of high-potency ingredients and the need for strict containment, process control, and integration. Eurofins CDMO Alphora addresses these challenges by offering a fully integrated, single-location model that streamlines ADC development and manufacturing.

Operating from its Hadwen site in Mississauga, Ontario, Eurofins CDMO Alphora integrates biologics, small molecule synthesis, linker-payload production, conjugation, purification, analytical testing, and fill-finish services within a single site. This vertically integrated approach reduces logistical hurdles, shortens lead times, minimizes cross-contamination risk, and enhances regulatory compliance. Single-use technology, isolators, and strict safety protocols are employed to ensure product and personnel safety while maintaining the integrity of highly potent APIs.

The facility supports the entire lifecycle of ADCs—from monoclonal antibody production for both non-GMP and GMP applications to full-scale ADC manufacturing and clinical batch support. Critical process parameters, including Drug-to-Antibody Ratio (DAR) and impurity control, are tightly monitored using advanced chromatography, LC-MS/MS, and other analytical tools available across Eurofins' global testing network.

Eurofins CDMO Alphora’s platform is uniquely positioned to handle the increasing demand for ADCs, projected to reach $44B globally by 2029. Its integrated solution not only simplifies the production model—often spread across multiple CDMOs—but also elevates process control, safety, and quality, making it a trusted partner for biopharma innovators advancing ADC candidates to market.

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