Accelerating Biologic and Bioconjugate Development: Key Bioassay Strategies for Successful IND Submission

Watch Abzena’s Senior Director, Bioassay, Erika Kovacs as she explores key considerations when developing stage-appropriate bioassays for complex biologics and bioconjugates, to accelerate and de-risk the development process to IND. Using case studies, she will provide insights into topics including selecting to right assay depending on development stage and MoA, overall application of developability for lead candidate selection, and requirements for GMP potency testing.

Overview

Progressing a new biologic or bioconjugate forward from discovery to IND can be a challenging process, especially considering the increasingly complex therapies being developed today. Having powerful and reliable bioassays throughout your development journey is key for generating a comprehensive data package that will allow you to make the best decisions, maximizing the likelihood of progressing a successful drug to the clinic. Like many processes during drug development, assay design and execution is a balancing act, ensuring that your bioassay resembles the desired pharmacology as closely as possible, while minimally compromising on sensitivity, robustness, accuracy and precision, is essential to the success of your program.

Objectives

• Assay requirements at different stages of development, i.e. early screening, detailed characterization, lot release testing
• How long-term data trending provides invaluable insights and creates reliable and robust assays
• How a quality PBMC cell bank coupled to data-rich flow cytometry readout gives you the most informative pre-clinical immunogenicity testing tool on the market
• How real-time microscopy of 3D and/or immune co-cultures can reveal insights into complex mode of actions for ADCs and bispecifics
• How partnering with Abzena for your bioassay needs can fast-track your program, providing state of the art assay solutions, as required, from start to finish

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