Kreuzreaktivität
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 gives you a practical checklist of disease state serum panels commonly required for IVDR performance evaluation, organised by assay type, so you can plan your […]
Natives Humanserum
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 across different analytical platforms. This post explains why native human serum without additives is the correct starting matrix for most IVD calibrators, and what “commutability” […]
IVDR-Probensets der Klasse D
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 (CTS 2009/108/EC) define not just what performance you need to demonstrate, but exactly which samples you need to demonstrate it with. This post breaks down […]
Xenofrei vs. serumfrei vs. tierkomponentenfrei
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 wrong one in a regulatory document or manufacturing protocol can cause confusion, delays, and compliance questions. Here is exactly what each means. Buy serum-free cell […]
FKS südamerikanischer Herkunft
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 the conversation. But if you are developing a GMP process, submitting an IND, or simply want to understand what origin actually means for your risk […]
2D- oder 3D-Single-Use-Beutel
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 volume, your application, and whether you are storing, freeze-thawing, or actively mixing. Here is the complete guide. Single-use bioprocessing bags – made to your process […]
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 assay development, biomarker validation, and cross-reactivity testing, you need serum that contains the actual analyte or pathological condition you are measuring — disease state serum. […]
BVDV-Prüfung von FKS – CPE vs. RNA/qPCR
August 2026 · 6 min read BVDV — bovine viral diarrhea virus — is the most significant viral contaminant risk in fetal bovine serum. It is also one of the most misunderstood aspects of FBS quality documentation. Many researchers assume that a “BVDV negative” result on the CoA means the serum is definitively free of […]
Normalserum zum Blocken in IHC & IF
August 2026 · 6 min read Blocking serum selection is one of those protocol details that gets copied from paper to paper without much thought — until you get high background that you cannot explain. The species of blocking serum matters. The concentration matters. The heat inactivation matters. Here is the complete guide. Why blocking […]
rHSA vs. BSA in serumfreier Zellkultur
August 2026 · 7 min read Both rHSA and BSA are albumin proteins used as serum replacements in cell culture, DMPK assay buffers, and IVD applications. They are not interchangeable. The choice between them determines whether your medium is animal-free, how well your cells grow, and whether your drug-protein binding data is physiologically relevant. Buy […]
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