Serum-Free Medium for AAV Production
Moving AAV production from serum-containing to serum-free medium is increasingly driven by regulatory pressure — particularly for IND-enabling and clinical-grade AAV where animal-derived components require extensive TSE/BSE documentation. This post […]
HEK293T Confluency at Transfection
Every AAV production protocol says it: “transfect at 70–80% confluency.” But few explain why this number is so critical — and fewer still explain how to actually measure it reliably […]
Why FBS Lot Variability Is the Biggest Variable in AAV Production — and How to Control It
Every AAV production lab has experienced it: two identical production runs, same protocol, same plasmids, same cell passage number — but a 3–5× difference in viral titre between runs. The […]
Cross-Reactivity
Cross-reactivity testing is one of the most under-resourced parts of IVD performance evaluation — until a Notified Body review flags missing data two weeks before your submission deadline. This post […]
Native Human Serum
When you develop an IVD calibrator, the choice of matrix is not a procurement decision — it is a scientific and regulatory decision with direct consequences for the assay’s performance […]
IVDR Class D Sample Sets
If you are preparing a CE marking submission for a Class D IVD — an HIV, HBV or HCV diagnostic — you will quickly find that the Common Technical Specifications […]
Xeno-Free vs Serum-Free vs Animal
August 2026 · 6 min read Xeno-free. Serum-free. Animal component-free. Chemically defined. These four terms appear in almost every cell therapy protocol — and they are not synonyms. Using the […]
FBS South American Origin
August 2026 · 6 min read When you order FBS, the supplier will tell you it is “South American origin” — and for most applications, that is the end of […]
2d or 3D Single Use Bags
August 2026 · 7 min read The most common question in single-use bioprocessing bag selection is not “which brand” — it is “2D or 3D?” The answer depends on your […]
Disease State Serum
August 2026 · 6 min read Standard human AB serum comes from healthy, screened-negative donors. For many research and diagnostic applications, that is exactly what you need. But for IVD […]
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