Why functional assays are crucial for biopharmaceutical development success

In biopharmaceutical development, functional assays are key to showing that a drug target fits the desired functionality and quality profile before moving on to the next stage of development. Often, more than one assay is required since biopharmaceuticals may have more than one mechanism of action (MoA).

Reporter-gene assays are growing in popularity as they can be designed to reflect a drug’s MoA, which is required by regulatory authorities to ensure efficacy and safety. Another area where functional assessment has gained traction is in relation to the complement system where drugs can interact with complement components and cause adverse effects.

In this webinar, Therese Segerstein and Ali Qamar, will explain how functional assays can be used in safe and compliant biopharmaceutical development. They will focus on functional platforms for complement assessment and cell-based solutions for measurement and quantification of drug potency, detection of neutralizing antibodies (NAbs), and assessment of immunogenicity.

Key learning objectives

• Understand the importance of functional assessment during drug development
• Learn about the advantages of functional bioassays and complement assessment for biopharmaceutical development
• Understand assay performance and advantages of the iLite^® cell-based reporter gene assays and the Wieslab^® Complement assessment immunoassays

Who should attend?

• Scientists involved in biopharmaceutical drug development in academics, biotech, or pharma settings
• Researchers interested in, or currently using functional assays
• Bioanalytical groups in pharma or contract research organizations (CROs)