Cell Line Development

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.

Interlot & Biosimilar Comparability

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.

Lot Release & Stability

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.

Process and Product Impurities

Process Impurities

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.

Product Impurities

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.