Antibody Drug Conjugate (ADC) Manufacturing
Build Smarter, Safer Processes
Antibody drug conjugates (ADCs) combine the cell-killing power of a cytotoxic drug with the targeting precision of an antibody into one biomolecule. Next-generation ADCs are bringing renewed momentum in the fight against difficult-to-target cancers.
Sartorius empowers ADC pioneers to overcome the challenges of safely producing these critical and life-saving therapeutics. Explore how our portfolio supports the creation of robust, high-performing processes.
Address cytotoxicity challenges with closed, single-use systems on automated systems that limit open handling and operator manipulations in support stringent containment protocols.
Ensure product integrity with chemically resistant polymers validated for use with organic solvents, hydrophobic payloads, and highly reactive linkers.
Achieve consistent drug-to-antibody ratios with scalable tools and integrated monitoring to support continuous, high-precision control.
ADC Workflow Overview
Take a closer look at how Sartorius' equipment paired with single-use solutions and services can accommodate your production scale and development phase to realize robust, efficient and flexible operations. Browse Sartorius offerings through the ADC workflow
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FAQs
Effective mitigation of exposure risk requires coordinating equipment, facilities, and procedures as a multifaceted set of containment strategies. Equipment used in process steps at or after the introduction of the cytotoxic compounds should feature automation to reduce or eliminate operator interactions and utilize single-use fluid pathways that are validated to effectively and reliably contain the solutions. Even then, leak detection systems and secondary containment of equipment may be necessary as an additional barrier against exposure in the event of a breach of containment of the fluid pathway.
Aseptic sampling devices or assemblies allow for the capture of solutions for offline analysis to confirm that processes are in specification. Well-designed devices prevent the ingress of contaminants, protect the operator from exposure, and are constructed of materials that are compatible with the process solution and will not alter the sample.
Inline sensors within processing vessels provide continuous monitoring and can be integrated with advanced data analytics systems. These systems perform predictive multivariate data analysis, allowing you to proactively adjust conditions to ensure a successful batch rather than take reactive measures to save a batch.
Automation creates consistency and reproducibility, and improves operator safety. Payloads are potent and expensive. Automated mixing, fluid transfer, and in-line monitoring reduce human error and establish the foundation of batch-to-batch consistency.
Out-of-control freezing processes can lead to aggregation and molecule degradation, which will affect the potency of the ADC. Equipment that closely controls the temperature profile of freeze and thaw steps and containers that are engineered to promote uniform freezing and thawing are necessary for a stable ADC.
Single-use systems eliminate any risk of cross-contamination because each use is its first and only use. Not only do single-use systems remove the burden of cleaning validation, but they also limit operator exposure to toxic compounds inherent to equipment that needs to be handled during cleaning procedures.
The filtration strategy needs to effectively remove particulates and aggregates and provide sterility. Consider 0.2 μm sterilizing filters with integrated larger pore pre-filter membranes. Selected membranes need to be compatible with ADC processes particularities such as use of aggressive solvents and the hydrophobicity payloads.
