Antibody Drug Conjugates
Antibody drug conjugates (ADC) represent a breakthrough in targeted cancer therapy, combining the precision of monoclonal antibodies with the potency of cytotoxic drugs. By delivering powerful treatments directly to cancer cells, ADCs provide an alternative solution that enhances efficacy and minimizes side effects.
Challenges and Solutions in Antibody Drug Conjugate Manufacturing
Antibody Drug Conjugate (ADC) manufacturing is a complex, multi-step process involving conjugation, filtration, purification and formulation of monoclonal antibodies, cytotoxic payloads, and chemical linkers.
Key challenges include
- Managing potency of the payloads
- Minimizing cytotoxin exposure to operators
- Ensuring consistent drug-to-antibody ratios (DAR) across batches
- Containment and storage
From early-stage development to commercial production, Repligen offers integrated solutions across key unit operations, including antibody production, conjugation, drug-linker preparation, closed system connectivity, and ADC formulation. These solutions enable optimization of ADC production processes for improved yields, product quality, operator safety and cost-effectiveness.
Start the Journey: Achieving Safety, Efficiency, and Flexibility in ADC Manufacturing
From theory to therapy- Immerse yourself in the world of antibody-drug conjugates (ADCs) in our latest white paper. Learn about the anatomy of ADCs, unique manufacturing challenges, and the critical role of single-use systems in ensuring safe, efficient, and flexible production processes. Glean insights and discover the operational advantages Repligen Tangential Flow Filtration systems and Chromatography systems offer to ADC manufacturers.
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Dig into the Data: Extractables Study on Single-use Consumables for ADC Production
When adopting single-use systems for ADC manufacturing, added emphasis is placed on the risk of extractables and leachables (E&L) from the flow kits and membranes. These substances, which may be released under certain conditions, could potentially impact the safety and efficacy of the final product. Our study delves into this concern, evaluating E&L from ProConnex® Flow Paths and TangenX® SIUS Gamma Cassettes, particularly in the presence of common solvents like dimethyl sulfoxide (DMSO) and dimethylacetamide (DMAC).
Analyze the Findings: Validation of ADC Platform for Drug-Antibody Ratio (DAR) using Variable Pathlength Technology
Critical to the design and evaluation of ADCs during formulation, Drug-Antibody Ratio (DAR) refers to the number of drug molecules attached to the antibody. But with several DAR measurement methods to choose from, which provides the greatest degree of accuracy and actionable insights? Discover the superiority of the variable pathlength technology that powers our CTech™ SoloVPE® PLUS and FlowVPX® systems in this insightful analytical review.
Collaborate with Confidence: Review of Single-Use Flat Sheet Cassettes in ADC Processing with Sanofi
When it comes to ADC purification, performance matters. Discover how Repligen’s TangenX® ProStream™ and HyStream™ tangential flow filtration (TFF) cassettes deliver high-efficiency output across critical ultrafiltration and diafiltration steps in ADC production. Developed in collaboration with Sanofi, this in-depth study showcases real-world data on solvent clearance, membrane integrity, and product recovery.