中文ADC Manufacturing Solutions
Supporting Scalable ADC Manufacturing from Conjugation to Final Formulation
ADC manufacturing requires precise control of conjugation efficiency and product consistency, while also addressing challenges associated with highly potent payload handling, process scale-up, cross-contamination control, and aseptic processing.
Built on LePure Biotech’s single-use technology platform, our solutions support ADC process development and commercial manufacturing with flexible, scalable, and reliable process capabilities.
Contact UsProcess Step
mAb Production
Prior to ADC processing, the monoclonal antibody is prepared as the starting material for subsequent conjugation steps.
Learn more about our integrated solutions for monoclonal antibody development and manufacturing.
mAb Freeze-Thaw
Frozen monoclonal antibodies are thawed under controlled conditions to help maintain protein structure and biological activity before subsequent ADC processing.Controlled freeze-thaw is an important step in supporting consistent antibody quality during scaled ADC manufacturing
Products:
Pre-Conjugation Preparation
Prior to conjugation, the mAb solution may undergo buffer exchange and concentration adjustment to establish suitable pH, ionic strength, and protein concentration for the subsequent conjugation reaction.
UF/DF provides a controlled approach to prepare the antibody in an appropriate reaction environment while supporting process consistency.
Products:
Single-Use Liquid Preparation System
Single-Use Liquid Storage System
Single-Use Liquid Preparation System
Filtration and Filters
Conjugation
Linker-payload materials are prepared for the conjugation reaction. ADC conjugation requires controlled reagent addition and mixing to achieve the target drug-to-antibody ratio (DAR), product stability, and process reproducibility.
The process must also address chemical compatibility and operator protection when handling highly potent payload materials.
Products:
Single-Use Liquid Storage System
Single-Use Liquid Preparation System
Single-Use Liquid Preparation System
Filtration and Filters
Single-Use Liquid Preparation System
Purification
Following conjugation, purification removes unreacted linker-payload, residual solvents, aggregates, and undesired DAR variants to improve ADC purity and product quality.
UF/DF supports the removal of small-molecule impurities, buffer exchange, and concentration adjustment. Chromatographic purification may be used where additional separation of aggregates or DAR variants is required.
Products:
Single-Use Liquid Preparation System
Single-Use Liquid Storage System
Filtration and Filters
Single-Use Liquid Preparation System
Formulation
The purified ADC is formulated with selected pharmaceutical excipients such as buffers, pH-adjusting agents, surfactants, stabilizers, and viscosity-modifying agents.
Controlled formulation helps maintain product stability and appropriate physicochemical properties during manufacturing, storage, and subsequent use.
Products:
Single-Use Liquid Preparation System
Single-Use Liquid Storage System
Single-Use Liquid Preparation System
Single-Use Liquid Preparation System
Sterile Filtration
Sterile filtration supports the removal of microorganisms and particulates before filling while maintaining a closed fluid pathway.
For ADC manufacturing, the filtration process must balance product recovery, filtration performance, containment, and operator protection when handling highly potent payloads.
Products:
Filtration and Filters
Filtration and Filters
Filtration and Filters
Filtration and Filters
Others
Aseptic Filling
Aseptic filling manifolds integrate bulk solution containers, tubing, filters, and filling needles into a closed fluid pathway.
Optimized manifold design supports closed fluid transfer, accurate filling, reduced product loss, and controlled aseptic processing, while also supporting operator protection during ADC filling operations.
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