Cytiva prioritizes the generation of standardized data for Cytiva product designs used in biopharmaceutical applications, especially where increased vigilance for patient safety or drug product quality is warranted, as well as for new product designs. Additional data for integrated components (e.g., tubing, fittings) may also be available from the component manufacturer.

USP <665> is the first extractables standard written specifically for bioprocess consumables; however, it is not currently a mandatory requirement from USP or regulators. USP <665> is increasingly expected to support risk assessments for higher-risk components but may not be available for all legacy materials or smaller, lower-risk materials, which can be assessed using existing compendial data.

USP <665> and BioPhorum datasets are well aligned regarding component definitions, overlapping solvent extraction timepoints, and intent. BioPhorum extractables datasets may include additional timepoints, a water extraction profile, and a focus on pH extremes. The BioPhorum 0.5 NaOH (~pH 13.5) solvent may not fully satisfy USP <665> requirements, particularly for high-risk components requiring a pH 10 solvent extraction profile without additional justification.

Cytiva validation services provide comprehensive end-to-end support, with more than 20 years of experience in extractables and leachables testing.