MERCEDES PEREZ OLIVARES1, ADELE E KINSEY2
1. Manager, Bioassay, Abzena, Cambridge, United Kingdom
2. Senior Manager, Bioassay, Abzena, Cambridge, United Kingdom

Abstract

Bioassays are a cornerstone of drug development, providing insight into the mode of action (MoA), potency, and potential immunogenicity of biologic therapeutics. These assays are utilized at various stages from early discovery to clinical trials. However, with so many variations that impact multiple outcomes, selecting the right bioassay is more than a matter of preference – it’s a potential make-or-break moment for a project. As advances in instruments and techniques continue to broaden the bioassay toolbox, this article focuses on what stage appropriate assays can be selected to drive our drug development process forward with increased chance of clinical success.

Introduction
Building a powerful data package early on ensures that a drug’s therapeutic profile is accurately characterized, helping developers identify promising candidates while avoiding costly late-stage failures. When designing a bioassay package, it is important to tailor the design for the appropriate stage of the discovery or development process. Bioassays are essential at all stages, whether it is early-stage researchers exploring novel targets or established companies who need an experienced CDMO that can adhere to good laboratory and good manufacturing practice (GLP/GMP). Choosing the correct assays can be an intricate process but is essential for answering the most critical questions and generating robust data.

A base for a bioassay data package
Assembling the most powerful bioassay data package requires a holistic approach that combines functionality and safety assessments tailored to each stage of drug development. The challenge lies in ensuring that the data package answers specific questions relevant to the client’s needs, whether they are early researchers exploring new targets or establ ...