Month: April 2026

Cell Line Characterization Before IND: What Regulators Actually Expect

Cell Line Characterization Before IND: What Regulators Actually Expect Cell line characterization before IND filing is one of the most consequential steps in early biologics development, and one of the most commonly underestimated. The FDA and ICH guidelines spell out what they want to see, but the practical question is what level of evidence is … Continue reading Cell Line Characterization Before IND: What Regulators Actually Expect

How to Validate a Stable Cell Line: Key Assays and Decision Points

How to Validate a Stable Cell Line: Key Assays and Decision Points Validating a stable cell line means confirming three things: the line expresses your protein of interest at acceptable levels, that expression holds over time, and the line is what you think it is – not a misidentified, contaminated, or genetically shifted version of … Continue reading How to Validate a Stable Cell Line: Key Assays and Decision Points

CHO vs HEK293 vs Sf9: How to Choose the Right Host Cell Line for Your Expression System

CHO vs HEK293 vs Sf9: How to Choose the Right Host Cell Line for Your Expression System Introduction Choosing a host cell line isn’t just a technical decision – it’s a project timeline decision, a budget decision, and sometimes a regulatory one. CHO, HEK293, and Sf9 are the workhorses of recombinant protein expression, but they’re … Continue reading CHO vs HEK293 vs Sf9: How to Choose the Right Host Cell Line for Your Expression System