Scientific Resources

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<i>In vitro</i> immune safety for biologics cytokine release, immunogenicity and ADA assays (1).png

Insights

8 October 2026

10 min read

In vitro immune safety for biologics: cytokine release, immunogenicity and ADA assays

How to assess cytokine release and immunogenicity risk in vitro before first-in-human dosing, which ADA assays are needed and what the guidance says.

Introducing RoukenCells Proven Cellular Tools for Modern Therapeutic Development (1).png

Insights

30 September 2026

12 min read

The in vitro data package: lead selection to IND

What in vitro pharmacology data do you need for a biologic IND filing? A practical guide to mechanism of action, potency, species relevance, immune safety and ICH S6(R1).

A Human-Relevant <i>Ex Vivo</i> IBD Model for Therapeutic Development and Preclinical Testing (2).png

Insights

4 September 2026

7 min read

Advancing Asthma Drug Discovery and Translational Research with a Human Air-Liquid Interface (ALI) Asthma Model

RoukenBio’s human donor-derived air-liquid interface (ALI) asthma model recreates key features of Type 2 airway inflammation, including mucus production and epithelial remodelling. Discover how this translational platform supports target validation, biomarker analysis and therapeutic evaluation in asthma drug discovery.

Blog image - A Human-Relevant <i>Ex Vivo</i> IBD Model for Therapeutic Development and Preclinical Testing.png

Insights

5 August 2026

5 min read

A Human-Relevant Ex Vivo IBD Model for Therapeutic Development and Preclinical Testing

Explore how RoukenBio’s patient-derived ex vivo IBD model preserves key tissue compartments to support more clinically relevant therapeutic testing for Crohn’s disease and ulcerative colitis.

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