Scientific White Papers
Distilling complex analytical science into actionable regulatory insights.
Technical White PaperMarch 2026
Advanced LC-HRMS for Oligonucleotide Impurity Profiling
"An in-depth look at high-resolution mass spectrometry methods for detecting low-level sequence variants and modifications in therapeutic ASOs."
Cite as: BrownBiology Analytical Journal Vol. 14
Request Full Version (PDF)Compliance InsightJanuary 2026
Beyond USP <1663>: Case Studies in Complex Container Closures
"A review of E&L challenges for biologics in pre-filled syringe (PFS) formats and the impact of silicone oil and tungsten residues."
Cite as: Regulatory Affairs Review 2026
Request Full Version (PDF)Methodology PaperNovember 2025
Statistical Approaches to Biosimilar Similarity Assessment
"Practical implementation of Tier 1, 2, and 3 statistical analysis for d茅monstrating equivalence in multi-attribute data sets."
Cite as: Internal White Paper Series
Request Full Version (PDF)More technical resources are under preparation.