Antibody-Drug Conjugate Bioprocessing Solutions

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Address inflection points at various bioprocessing stages

Antibody-drug conjugate (ADC) development often involves chemical and biological steps that do not typically behave predictably. Factors such as conjugation variability, shifts in solvent behavior, handling of hydrophobic reagents, and strict controls for cytotoxic materials can influence process development stability as work moves closer to manufacturing. Strengthening these points early can reduce operational strain later in the workflow and supports steadier progress as programs advance.

Streamline ADC workflows to enhance consistency

ADC development relies on a sequence of operations that must hold steady as conditions shift. Solvent behavior, reaction setup, and early purification steps can run a process off course if they are not coordinated. Establishing a path across these activities helps teams anticipate variation, maintain steadier drug-to-antibody (DAR) ratios, and reduce the minor disruptions that accumulate during batch-to-batch work.

Improve reaction control and process monitoring

Facilitate consistent reaction conditions to better manage solvent behavior, temperature changes, and mixing demands in development. Maintaining steadier parameters helps limit operator exposure, reduce the risk of leaks, and support a more predictable distribution of DARs.
 

Advance ADC purification with high-resolution DAR separation

Support downstream purification by improving the resolution of DAR species. Variability can complicate polishing and influence overall product quality. Thermo Scientific POROS Hydrophobic Interaction Chromatography (HIC) resins offer higher separation than phenyl or butyl chemistries.

Address aggregation with mixed-mode purification

Help prevent aggregation early by applying purification steps that address the complex behavior often observed in intermediates. Thermo Scientific POROS Caprylate Mixed-Mode Cation Exchange Resin supports flow-through reduction of aggregates through its distinct selectivity.

Optimize buffer and solvent management

Promote efficient solvent and buffer preparation by stabilizing sourcing and formulation across workflows. cGMP Chemical Sourcing Services and Process Liquid Preparation Services support consistent access to solvents, cGMP chemicals, buffers, and process liquids used throughout purification.

Advance ADC processes from development to clinical production

ADC programs can place pressure on teams as they move from early development into manufacturing. Aligning single-use technologies, sourcing, logistics, and regulatory documentation helps maintain continuity during these transitions and reduces the operational strain that can appear during scale-up.

Support efficient mixing for purification

Mixing demands often shift as solvents, hydrophobic reagents, and temperature-sensitive steps are introduced. Single-use mixers, such as the Thermo Scientific HyPerforma Single-Use Mixer and the Thermo Scientific imPULSE Single-Use Mixer, range from 30 L to 5,000 L. Each platform includes comprehensive documentation and access to technical specialists, helping teams set up reliable mixing without increasing handling demands.

 

Scale chromatography with a high-performing system

Adapt purification steps as ADC programs advance, using a chromatography system designed to meet process needs. The Thermo Scientific DynaChrom Single-Use Chromatography System supports reconfiguration from pilot work to production with durable flow paths, Quattroflow™ pumps, and sensors for more prolonged use.

 

Increase productivity with flexible containment

Tank liners, 2D and 3D bioprocess containers, and secure transfer assemblies support solvent and buffer management while helping reduce batch turnaround time. These options help consolidate handling steps and maintain control as materials move between operations.

 

Strengthen fill-finish reliability for ADC drug product

ADC drug product handling benefits from consistent, low-particulate containment. Thermo Scientific Labtainer Pro Bioprocess Containers, paired with the Thermo Scientific BioTitan Retention Device, support clean transfer and final processing. At the same time, fill-finish formats can be configured to meet specific application needs.

 

Improve analytical confidence across production

Assess identity, purity, contamination, and safety with limited sample use and shorter turnaround times. The Applied Biosystems SEQ portfolio includes solutions for microbial testing, mycoplasma detection, sterility, viral screening, and residual DNA, improving analytical confidence across antibody-drug conjugate production.

 

Frequently asked questions

ADC bioprocessing brings together the steps required to create an antibody-drug conjugate, starting with monoclonal antibody preparation and moving through conjugation, purification, formulation, and final fill-finish. Each stage needs careful control to maintain stability and manage the distribution of conjugated species. When these steps work together smoothly, the resulting material can be prepared consistently for storage and clinical use.

Development teams often face a combination of chemical, biological, and operational pressures during development and ADC manufacturing. Cytotoxic materials require strict handling controls. Shifts in drug-to-antibody ratio distribution can make downstream work more demanding. Aggregation may surface during or after reaction steps, while solvent compatibility influences mixing, temperature management, and chromatography. Because DAR species and hydrophobic components behave differently, purification strategies often need to be adjusted.

Integrated solutions help steady the steps sensitive to shifts in ADC workflows. POROS HIC resins can separate DAR species with clear resolution, while mixed-mode resin can support flow-through reduction of aggregates without adding extra complexity to downstream work. Flexible solvent and buffer management, supported by reliable sourcing and preparation, helps teams maintain stable reaction conditions and reduce the operational strain associated with handling organic solvents.

Workflow optimization helps teams limit the factors that commonly lead to material loss or repeat work. Reducing aggregation lowers the burden on downstream steps. Improving consistency during conjugation supports steadier DAR distribution. More reliable buffer and solvent management reduce the chance of off-spec batches tied to preparation errors. Together, these improvements help stabilize raw material use and minimize batch-to-batch variability.

Thermo Fisher aims to bring together conjugation, purification, containment, and analytical tools into a single connected framework. Early steps benefit from robust mixing and solvent management options, while POROS HIC resins, as well as mixed-mode resin, help manage DAR distribution and aggregation. Containment systems and global sourcing capabilities support handling and supply chain continuity, giving teams a workflow that adjusts as programs move toward clinical development.

Supporting other therapeutic modalities

Thermo Fisher supports a variety of bioprocessing applications and therapeutic antibody workflows, including monoclonal antibodies and bispecific formats.

Monoclonal antibodies (mAbs)

Support consistent mAb development with solutions for cell culture, purification, buffer preparation, analytics, and single-use processing designed to maintain performance from research through manufacturing.

Bispecific antibodies (bsAbs)

Advance bsAb development with tools that support controlled expression, efficient purification, and stable processing across complex molecular formats.
 

For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.