Protect What Matters in ADC Manufacturing
Enabling Safer, Reliable, and Scalable ADC Production
ADC manufacturing comes with intricate challenges like process variability, maintaining quality during scale-up, and pervasive safety risks from handling highly potent compounds.
Protect your molecule, process, and operator with consistent, closed, and scalable solutions from Sartorius that drive reliable performance, safer operations, and streamlined progress to commercial success
From mAb to final ADC, controlled thawing, low-shear handling and precise process control protect the antibody structure to keep conjugation and DAR on target.
Chemically compatible single‑use materials on automation-optimized equipment with continuous inline monitoring keep ADC processes optimized for reproducible performance at any scale.
Automation and closed, single‑use fluid paths reduce manual intervention and separate operators from cytotoxic ADC payloads, integrating safety directly into process design.
ADC Workflow Overview
Protect your molecule, process, and operator with consistent, closed, and scalable solutions for ADC manufacturing.Take a closer look at how our equipment pairs with single-use solutions and services to accommodate your needs. From research and development to production scale and the development phase, we help you drive robust, efficient, and flexible operations.
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FAQs
The primary challenges in antibody drug conjugate (ADC) manufacturing include maintaining the biological activity of the monoclonal antibody (mAb), controlling the drug-to-antibody ratio (DAR) during the automated ADC conjugation process, managing chemical compatibility with aggressive solvents, and implementing stringent containment strategies to protect operators from highly potent cytotoxic payloads.
Effective containment strategies for ADC manufacturing require closed, single-use fluid pathways combined with automated equipment. By leveraging aseptic connectors, sealers, and automated mixing systems, ADC manufacturers can minimize open handling, prevent toxic exposure to highly potent APIs, and strictly adhere to occupational exposure limit safety compliance.
An automated ADC conjugation process prevents the drift of critical process parameters and minimizes the risk for human error. Leveraging closed-loop, fully automated skids like Sartoflow® Expert with integrated inline monitoring ensures a consistent DAR, yielding highly reproducible performance from early process development to commercial scale-up.
Uncontrolled freezing and thawing during the antibody drug conjugate manufacturing process can lead to protein aggregation and molecule degradation, significantly reducing therapeutic efficacy. Using equipment that strictly controls the temperature profile alongside single-use bags engineered for uniform freezing protects the molecule and preserves the stability of the final ADC.
ADC manufacturers prefer single-use systems because they eliminate the risk of cross-contamination and bypass the complex, hazardous cleaning validations associated with cytotoxic compounds. In addition, advanced single-use films are specifically engineered for chemical compatibility with the harsh organic solvents routinely used in ADC services and production.
Selecting filters for an antibody drug conjugate manufacturing process requires evaluating membrane chemical compatibility against aggressive solvents and hydrophobic payloads. A robust filtration strategy typically uses 0.2-μm sterilizing-grade filters with integrated pre-filter membranes to efficiently remove aggregates, maximize product yield, and ensure the sterility of the final therapeutic.
