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Cell Line Development for Diagnostic Assays: Building the Foundation Your Platform Depends On

Cell Line Development for Diagnostic Assays: Building the Foundation Your Platform Depends On Cell line development for diagnostic assays is one of the most underestimated steps in bringing an in vitro diagnostic product to market. Diagnostic companies invest heavily in assay chemistry, reagent optimization, and clinical validation. However, the cell line powering the assay often … Continue reading Cell Line Development for Diagnostic Assays: Building the Foundation Your Platform Depends On

Serum-Free Cell Culture Media: Benefits, Challenges, and How to Make the Switch

Serum-Free Cell Culture Media: Benefits, Challenges, and How to Make the Switch Serum-free cell culture media has moved from a niche research interest to a mainstream expectation across biopharmaceutical manufacturing, diagnostics, and academic science. More labs are making the transition every year, and the reasons are compelling. Understanding what drives this shift, and what it … Continue reading Serum-Free Cell Culture Media: Benefits, Challenges, and How to Make the Switch

Mycoplasma Cell Culture Contamination: How to Detect, Eliminate, and Prevent It

Mycoplasma Cell Culture Contamination: How to Detect, Eliminate, and Prevent It Mycoplasma cell culture contamination is one of the most common and costly problems in biological research and bioprocessing. Unlike bacterial or fungal contamination, mycoplasma infections are invisible to the naked eye and will not cloud your media. These organisms grow silently alongside your cells, … Continue reading Mycoplasma Cell Culture Contamination: How to Detect, Eliminate, and Prevent It

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