No biologic or pharmaceutical product can be produced without first testing the identity, purity, and quality of the raw materials. This critical step helps prevent costly production issues and delays.
Advanced Therapeutic Medicinal Products (ATMPs) represent a revolutionary and fastgrowing class of therapies at the forefront of modern medicine, distinct from traditional biopharmaceuticals. T
The biological activity, or potency, of a biopharmaceutical is a critical quality attribute as described in the ICH Q6B guideline. It is defined as the quantitative measure of biological activity based on attributes linked to the relevant biological properties.
From starting materials to finished product testing, and preclinical and post-commercialisation, Eurofins BioPharma Product Testing delivers the most comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance across the globe.
Comprehensive services for the analysis of active ingredients and excipients are offered, including support for raw material release for production and supplier qualification.
Strict quality control and batch release guidelines in the EU require a Qualified Person (QP) to issue a batch release certificate, register it, and take personal responsibility for the release of pharmaceutical or clinical investigational products from third countries.
Eurofins BioPharma Product Testing Hamburg GmbH now offers the option of a 7-day express analysis for selected analyzes, both according to EP and USP.
During drug development, it's crucial to assess the potential for chemicals to migrate from container systems, components, or devices into pharmaceuticals. Regulatory agencies require extractables and leachables (E&L) testing to identify product contamination risks.
Eurofins BioPharma Product Testing offers microbiology and chemistry services for facility monitoring and process validation, all compliant with cGMP. With over 250 successful projects, we provide flexible solutions for pharmaceutical and biopharma manufacturers.
Next-Generation Sequencing (NGS) is a high-throughput, scalable technology for DNA and RNA sequencing, offering fast and efficient QC checks for regulatory compliance. Eurofins provides GMP-compliant NGS services with strict quality control, documentation, and traceability.
The European Pharmacopeia outlines requirements for Herbals, covering Herbal Drugs, Herbal Drug Preparations, Herbal Teas, and Herbal Drug Extracts, along with individual product monographs like Senna leaf and Matricaria flowers.
Recent updates to pharmacopeias have overhauled heavy metals analysis. The ICH Q3D guideline (2014) harmonized approval processes, replacing USP <231> visual tests with instrumental methods (USP <232>, <233>).
Eurofins BioPharma Product Testing Munich is an internationally active lab offering safety and activity testing, with a broad range of microbiology studies for product testing, facility, and production monitoring of (bio-)pharmaceuticals and medical devices.
Eurofins BioPharma Product Testing employs advanced technologies to accurately identify bacteria, molds, and yeasts, supporting environmental monitoring and contaminant analysis.
Pyrogens are heat-stable substances derived from bacteria, fungi, or viruses that can induce fever in humans. As such contaminations with pyrogens in parental pharmaceuticals pose life-threatening risks, thus the degree of contamination is a critical quality control measure to ensure patient safety.
Mycoplasma contamination testing, essential for regulatory compliance, ensures product safety through traditional and advanced methods like MycoSEQ™ and BIOFIRE®, aligning with global pharmacopeial standards.
The full range of lecithin services is offered, including DGF, USP, and FCC tests, along with chemical, microbiological, and physical examinations, supported by over 375 laboratories worldwide within the Eurofins Group.
Eurofins is a global leader in dioxin, PCB, and POPs analysis, combining state-of-the-art instruments and expert knowledge. With a focus on GMP quality standards, Eurofins established the world's only GMP dioxin lab, meeting USP and EP requirements.
Comprehensive services for pharmaceutical-grade glycerol include EP, JP, USP, JECFA, and VO 231/2012 tests, along with chemical, microbiological, and physical examinations. Eurofins' global network of 375 labs and 30,000 experts supports your needs.
Eurofins BioPharma Product Testing provides GMP importation testing and Qualified Person (QP) assessments for bio/pharmaceutical products entering the EU, ensuring compliance with EU regulations for over 20 years.
Eurofins BioPharma Product Testing offers secure sample storage, testing, and project management services, including biochemistry, chemistry, microbiology, and custom stability studies, using your procedures or compendial methods.
Eurofins BioPharma Product Testing provides comprehensive raw materials testing, including method development and vendor qualification, ensuring identity, purity, and quality for bio/pharmaceutical production, in compliance with EP, USP/NF, BP, JP, ACS, and FCC standards.
Eurofins BioPharma Product Testing provides cGMP-compliant microbiology services for sterile and non-sterile product testing, facility monitoring, and raw materials testing, using clean room and isolator technologies for sterility testing.
Eurofins BioPharma Product Testing offers trace metal contamination screening and a range of assays for drug substances, raw materials, cleaning validation, and final product assays, using advanced techniques like ICP-MS, ICP-OES, and more, in compliance with pharmacopeias and ICH Q3D.
