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German Newsletter 2023

Vollmonographische Analysen von Pharmawasser

Eurofins BioPharma Product Testing bietet umfassende Tests für pharmazeutisches Wasser an, um Kontaminationen in der Arzneimittelherstellung zu vermeiden.

Annex 1: The road to compliance

Hersteller steriler Arzneimittel müssen nun eine Kontaminationskontrollstrategie entwickeln. Weitere Infos und Auswirkungen des aktualisierten Annex 1 finden Sie in unserem Flyer und bei unserem Seminar in Planegg.

Nitrosamine in humanen Arzneimitteln

Nitrosaminverunreinigungen wurden 2018 nach Rückrufen von Valsartan und Losartan wegen NDMA bekannt und müssen laut EMA-Richtlinien in allen chemischen und biologischen Arzneimitteln geprüft und kontrolliert werden.

ICH Q3D: Begrenzung toxischer Elemente

Seit 2016 sind Risikoanalysen zu elementaren Verunreinigungen (ICH Q3D) bei Neuzulassungen verpflichtend, seit 2017 auch für zugelassene Arzneimittel.

Services Newsletter

TruGraf Liver Optimizes Immunosuppression

TruGraf® Liver is a blood-based mRNA gene expression test that helps optimize immunosuppression therapy in liver transplant recipients by providing early, accurate insights into immune quiescence.

Genetic screening of embryos in IVF

Rising maternal age and infertility rates have increased the use of ART and PGT, with noninvasive PGT-A offering a promising alternative to biopsy, reducing costs and mosaicism risks.

Oxidative Stress in Cell Culture

Eurofins BioPharma Product Testing's Raw Materials team supports the growing cell and gene therapy (CGT) industry by developing new testing standards, publishing research, and collaborating with partners to address unique challenges in CGT, including stability studies in cell culture applications.

Eurofins CDMO Expands Plasmid DNA Services

Plasmid DNA (pDNA), essential for gene therapies, DNA vaccines, and RNA production, is driving the growth of the cell and gene therapy market, prompting Eurofins CDMO in Ghent, Belgium, to expand its pDNA manufacturing capacity with a comprehensive production platform.

Storage & Stability Special Edition

The ICH Q1A (R2) guideline defines stability testing requirements to ensure drug quality over time, while ICH Q1D optimizes testing with bracketing and matrixing.

BioPharma Services News

In this latest edition of our Eurofins BioPharma Newsletter, we bring you cutting-edge insights into the world of biopharmaceutical innovation. From advancements in clinical research to regulatory updates, our team is committed to driving excellence in drug development.

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