Chemistry Today: Building Your Bioassay Data Package

19th June 2024

Chemistry Today’s June 2024 journal features an article by our Sr. Manager of Bioassay, Adele Kinsey and Manager of Bioassay, Mercedes Pérez Olivares, MSc. PhD, discussing the important role that bioassays play in de-risking and streamlining a biopharmaceutical’s path to the clinic.

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 established pharmaceutical companies seeking GMP compliance. Early-stage researchers often require high-throughput screening and functional assays to identify promising leads. 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 established pharmaceutical companies seeking GMP compliance.

Early-stage researchers often require high-throughput screening and functional assays to identify promising leads.

Tailored data packages, built after extensive discussion with a client, may include a combination of in silico approaches, reporter assays, cytotoxicity assays, and internalization assays to refine their candidate selection criteria. For clinical developers, regulatory-compliant potency assays and immunogenicity assessments are indispensable. Comparative relative potency assays using luminescence endpoint assays ensure manufacturing consistency, while PBMC time course assays, dendritic cell (DC):T cell assays and cytokine profiling provide a detailed understanding of the triggered immune response. If we integrate these assays into a comprehensive package, it minimizes a project’s risk of failure and also helps with a smoother transition to clinical trials. This data package must be built on a solid base that helps us understand a few key factors:

1. Mode of action: it’s crucial we have a good understanding of the therapeutic MoA, especially when we’re dealing with complex treatments like antibody-drug conjugates (ADCs), bispecific T-cell engagers, and other immune modulators.

2. Potency and safety: bioassays that help you get a handle on potency and safety can eliminate major delays at later stages as well as ensure manufacturing consistency.

3. Immunogenicity risk: assays in this group will identify any potential immune responses against biotherapeutics. Immunogenicity testing is absolutely essential because immune responses against a therapeutic can range from antibody responses with no apparent clinical manifestations to life threatening and catastrophic reactions.

Next, we have to consider the stage of development a client is at, as this plays a huge role in determining which bioassays are most suitable.

Click here to access the full article.

Abzena’s Bioassay Expertise

Our in-house team of bioassay assay scientists has over 20 years of experience in developing phase-appropriate bioassays for the assessment of potency, efficacy, and safety. The critical data we generate gives you the tools to make effective decisions during your drug development journey and ensures better success in the clinic. From gene expression and functional analysis to target binding and immunogenicity assays, our comprehensive assessment services will de-risk and streamline your development program. Click here to learn more about our analytic and bioassay offering.