A reversed-phase liquid chromatography–charged aerosol detector (RPLC–CAD) method was developed and validated per ICH Q2(R1) guidelines for simethicone quantification.
Xuemei Han
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Xuemei Han is with Tanvex Biopharma USA, Inc. in San Diego, California.
Articles by Xuemei Han
Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.
Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.
In biotherapeutics manufacturing, controlling size variants of therapeutic monoclonal antibodies (mAbs) is critical for ensuring product quality.
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Latest Updated Articles
Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC MethodPublished: June 28th 2024 | Updated:
Characterization of Product Related Variants in Therapeutic mAbsPublished: October 15th 2024 | Updated:
- Characterization of Product Related Variants in Therapeutic Monoclonal Antibodies
Published: July 16th 2024 | Updated:
An RPLC Method with CAD for the Quantification of Residual Simethicone in Biologic ProductsPublished: October 23rd 2025 | Updated:
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