Streamlining ADC testing: The role of CRO collaboration in analytical services
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Analytical laboratory services play a crucial role in drug development, enabling a wide range of testing and analysis — such as chemical characterization, stability testing and bioanalytical assays — which are essential for ensuring the quality, safety and efficacy of products. By outsourcing these tasks to a contract research organization (CRO), companies can leverage specialized expertise, advanced technologies and regulatory knowledge. In addition, scientific teams across the various labs can collaborate and transfer knowledge across areas or labs to facilitate best practice, streamline testing and accelerate studies.
One example of this is in the complex testing needed for antibody-drug conjugates (ADCs). Bioanalytical and GMP labs are both used in ADC development but each in different ways:
- GMP labs test the drug product
- Bioanalytical labs test samples from patients in clinical trials
Although their analytical goals are different, both labs make use of cell-based assays at various stages to value different aspects of function and efficacy. Two specific examples are potency assays — used by GMP labs — and neutralizing antibody (NAb) assays — used by bioanalytical labs.
In the GMP lab, a potency assay measures the biological activity of a drug substance. It is designed to determine the drug’s ability to produce a desired effect at a specific concentration. This assay is crucial for quality control, stability, dose-response relationship and regulatory compliance.
In the bioanalytical lab, a neutralizing antibody assay detects and measures the presence of antibodies that can neutralize the biological activity of the ADC. These assays are important for evaluating immune response, safety assessment, efficacy monitoring and regulatory compliance.
With active collaboration and knowledge transfer the GMP lab and the bioanalytical lab can use the same cell-based method backbone for potency assays and neutralizing antibody (NAb) assays, reducing time and cost for study sponsors. The specific advantages are:
- Streamlined workflow: Using the same cell lines and method backbone allows the labs to simplify the assay development process. Sharing information between teams for dose-response curve levels, optimized incubation times, and optimized cell maintenance can reduce development time and move the project along more quickly. Sharing the cell line between labs reduces ordering time and cost and provides redundancies with storing cells within one CRO.
- Cost-effectiveness: Using shared information from development can be more economical, as it leverages existing method parameters and reduces the need for extensive new assay development. This approach can save time and resources, making the process more cost-effective. Also, identifying intricacies of the cell line may reduce time needed for troubleshooting as information can be shared between groups.
The collaboration and knowledge transfer between GMP and bioanalytical labs within CROs significantly enhance the efficiency and cost-effectiveness of drug development processes. By utilizing shared cell-based assay methods, these labs streamline workflows and reduce development time, benefiting study sponsors through faster and more economical testing. The integrated efforts ensure the quality, safety and efficacy of pharmaceutical products, driving advancements in drug development.
