USP Releases New General Chapter 〈89.3〉: Advancing Endonuclease Standardization in Biopharmaceutical Manufacturing

The United States Pharmacopeia (USP) has released General Chapter ⟨89.3⟩ Endonuclease (Serratia marcescens), introducing a harmonized framework for measuring endonuclease activity: See here! This marks an important step toward greater standardization for a critical ancillary material used in modern biopharmaceutical and cell and gene therapy (CGT) manufacturing.

The new chapter provides practical guidance for assessing the activity of endonucleases derived from Serratia marcescens, an enzyme widely used to reduce host cell DNA and RNA during downstream processing. By establishing a more consistent analytical approach, USP ⟨89.3⟩ supports improved comparability across commercially available endonucleases and helps align testing strategies with current and future pharmacopeial expectations.

In line with this advancement, Kerry will introduce the USP⟨89.3⟩ activity assay for Denarase^®. As a result, Certificates of Analysis (CoAs) will be supplemented to include USP-aligned activity and specific activity values as additional information alongside the established Product Specification, offering customers greater transparency and confidence in evaluating product performance.

Adopting USP ⟨89.3⟩ supports regulatory credibility and enables more direct comparison of products available on the market. For manufacturers operating in highly regulated biopharmaceutical and CGT environments, this represents a meaningful step toward clearer quality benchmarks and more informed material selection. 

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