Our off-the-shelf mAb assay packages are designed to speed time to actionable data for decision making. Each package offers novel assays that provide you the information needed to assess your biotherapy’s critical quality attributes, and selecting a pre-configured package is just the start. We’ll discuss details with you to ensure our testing meets your unique needs. Your biotherapy’s development program is led by a dedicated project manager, expert scientists, and regulatory teams who work with you to confidently select the best options to move forward.
Our comprehensive program combines physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug — its critical quality attributes.
Whether your mAb therapy is an original product or a biosimilar, it is important to perform comparability studies throughout the entire biopharmaceutical manufacturing process. When comparing between production lots, or a biosimilar to its originator therapy, you can be confident our assays deliver rigorous evaluations with trusted results.
Delivery of a regulatory-compliant biotherapy to market requires lot release testing at clinical and commercial stages of biotherapeutic development. These assays are essential to understanding the effects of environmental conditions like temperature, humidity, light, and container interactions on your mAb. This is achieved through comprehensive stability testing to inform storage conditions and retest intervals.
Defined as being different mAb products to the intended product, mAb product impurities may significantly impact the biotherapy’s clinical efficacy. Choose from a number of assays to mitigate risk throughout your drug’s development.
Developed as early detection methods, our assays ensure that process impurities levels remain below the acceptable thresholds for regulatory-compliant biopharmaceutical manufacturing. Arising from raw materials, occurring as residual processing agents, or formed as reaction by-products, contaminants must be continually monitored to ensure a product’s quality and safety.
Antibody Drug Conjugates
The primary mechanism of action (MoA) for ADCs is direct cytotoxicity through intracellular release of a toxin following specific binding to target tumor antigen. However, understanding the role of the antibody in directing an ADC to tumor cells and the potential for immune recruitment as a contributing MoA reinforces the importance of understanding your ADC's critical quality attributes.