Eurofins BioPharma Product Testing Germany

Eurofins BioPharma Product Testing Germany

Arzneimittelherstellung

Planegg/Munich, Bavaria 10.202 Follower:innen

Testing for Life - in Europa

Info

Willkommen auf der Unternehmensseite der Eurofins BioPharma Product Testing (BPT)-Laboratorien in unserer Region, die auf eine bis zu 90-jährige Erfahrung zurückblicken können. Wir sind Teil des weltweit größten Netzwerks von GMP-Prüflaboren, das umfassende Labordienstleistungen für (bio-)pharmazeutische Unternehmen anbietet. In Europa beraten wir Sie an über 30 Standorten. So unterstützen wir Kunden in den Bereichen der (bio)chemischen und mikrobiologischen Prüfung von Rohstoffen, API und Fertigarzneimitteln (kleine und große Moleküle, Biologika): Chargenfreigabe (auch durch eine Qualified Person, QP), Methodenentwicklung/-validierung, ICH-Stabilitätsstudien (einschließlich kontrollierter Lagerung) sowie Bioassays, In-vitro-Toxikologie & Pharmakologie sind Beispiele für unsere Dienstleistungen, die Ihnen helfen, sichere Human- und Tierarzneimittel auf den Markt zu bringen. Unsere einzelnen Standorte verfügen über einzigartige Fachkenntnisse in verschiedenen Bereichen. Durch unser internes Cross-Audit-Verfahren bieten wir unseren Kunden einen schnellen und rechtssicheren Zugang zu allen Labors des globalen BPT-Netzwerks. Mit unseren Laboren bieten wir unseren Kunden in unserer Region die umfangreichsten Labordienstleistungen und größtmögliche Kapazitäten mit modernster technischer Ausstattung und Softwarelösungen. Unsere Standorte sind sowohl nach GMP als auch nach GLP zertifiziert. Darüber hinaus sind mehrere Standorte nach DIN EN ISO 17025 für die Prüfung von Medizinprodukten akkreditiert. Die BPT-Standorte wurden bereits mehrfach erfolgreich von der US Food and Drug Administration auditiert.

Branche
Arzneimittelherstellung
Größe
1.001–5.000 Beschäftigte
Hauptsitz
Planegg/Munich, Bavaria
Art
Kapitalgesellschaft (AG, GmbH, UG etc.)
Gegründet
1987
Spezialgebiete
Bioassay, Microbiology, Biocompatibility, In Vitro Toxicology, Tailor-made Studies, Pharmaceutical Testing, Biopharma Product Testing, Medical Device Testing, Human Safety Testing, Chemical Testing, GLP Laboratory, GMP Laboratory, Pharmaceutical Water Testing , Small Molecules, Large Molecules, Reference Standards, Sterility Testing, Dissolution, Rapid Microbial Methods, Pharmacopoeias (EP, USP, JP, and many more), Raw Material, Biologics, Reference Standards Management, Release Testing, ISO 17025, REACH, ICH Guidelines, Environmental Monitoring, Persistence Organic Pollutions (POPs) analyses , Analytical Method Development, NMR, Spectroscopy , GMP, Cell and Gene Therapy, Proteinanalytics und Biochemistry

Orte

Beschäftigte von Eurofins BioPharma Product Testing Germany

Updates

  • Join us on 𝟭𝟵 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟱 𝗶𝗻 𝗛𝗮𝗺𝗯𝘂𝗿𝗴 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝘆 𝗧𝗿𝗲𝗻𝗱𝘀 & 𝗖𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 hosted by Eurofins Biopharma Product Testing Germany. 🌟 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲: • 𝗘𝗻𝗱𝗼𝘁𝗼𝘅𝗶𝗻 𝗗𝗲𝘁𝗲𝗰𝘁𝗶𝗼𝗻: LAL/rFC comparisons and transitioning to rFC for diverse product applications. • 𝗣𝘆𝗿𝗼𝗴𝗲𝗻 𝗗𝗲𝘁𝗲𝗰𝘁𝗶𝗼𝗻: MAT test kit trends and comparative analysis. • 𝗦𝘁𝗲𝗿𝗶𝗹𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴: Rapid sterility test comparisons, including innovative methods. • 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗮𝗹 𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Achieving species-level precision with Bruker MALDI-TOF. • 𝗟𝗮𝗯 𝗧𝗼𝘂𝗿: Explore Eurofins BPT Hamburg’s cutting-edge microbiology laboratories. This is your chance to stay ahead in the evolving world of microbiology and ensure the safety and success of your pharmaceutical products. 📍 𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻: Das Privathotel Lindtner, Hamburg, Germany 💻 𝗟𝗲𝗮𝗿𝗻 𝗠𝗼𝗿𝗲 & 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿: https://lnkd.in/dE5pCW6Q #Microbiology #PharmaceuticalTesting #Biopharma #Endotoxin #SterilityTesting #PyrogenDetection #MicrobalIdentification #MAT #LAL #rFC #MaldiTof

  • 𝗠𝗲𝗲𝘁 𝘂𝘀 𝗮𝘁 𝘁𝗵𝗲 GMP-PharmaCongress & GMP-PharmaTechnica! We’re excited to connect with industry experts and discuss the latest in #GMP compliance, pharmaceutical testing, and innovation. Visit us at 𝗕𝗼𝗼𝘁𝗵 𝗕𝟲 to learn how we can support your projects with our expertise! 📅 When? 8-9 April, 2025 📍 Where? GMP-Pharma Congress in Wiesbaden, Germany 🔗 More info: https://lnkd.in/e9cGCNK Let’s talk quality, compliance, and the future of pharma! See you there! 👋 #BioPharma #PharmaCongress #PharmaceuticalTesting #QualityMatters #PharmaTechnica

    • Kein Alt-Text für dieses Bild vorhanden
  • 𝗗𝗶𝗱 𝘆𝗼𝘂 𝗸𝗻𝗼𝘄 𝘄𝗲 𝗼𝗽𝗲𝗿𝗮𝘁𝗲 𝟰 𝘀𝘁𝗮𝘁𝗲-𝗼𝗳-𝘁𝗵𝗲-𝗮𝗿𝘁 𝗚𝗠𝗣 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 𝗮𝗰𝗿𝗼𝘀𝘀 𝗚𝗲𝗿𝗺𝗮𝗻𝘆? 🌟 Our labs in 𝗠𝘂𝗻𝗶𝗰𝗵, 𝗛𝗮𝗺𝗯𝘂𝗿𝗴, 𝗛𝗼𝗺𝗯𝘂𝗿𝗴, 𝗮𝗻𝗱 𝗖𝗼𝗻𝘀𝘁𝗮𝗻𝗰𝗲 provide 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗚𝗠𝗣 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀, ensuring the highest quality standards for your products. Our expert services include: ✔️ Method Development & Validation ✔️ Stability Studies & Storage (ICH & non-ICH) ✔️ Raw Material and Finished Product Testing ✔️ Method Optimisation & Revalidation ✔️ Product Release Testing ✔️ Cleaning Validation Studies ✔️ Cell & Gene Therapy ✔️ Extractables & Leachables ✔️ Elemental Analysis ✔️ Microbiology & Micro Identification ✔️ Disinfectant Testing 🔍 Looking for trusted GMP testing solutions? Let’s partner to achieve your quality goals! 📧 Get in touch with us at PharmaTesting@bpt.eurofinseu.com 🌐 Or learn more at www.eurofins.de/bpt #BioPharma #GMP #Microbiology #QualityAssurance #PharmaceuticalTesting #GMPCompliance #MethodValidation #StabilityStudies #PharmaQuality #CellAndGeneTherapy #PharmaInnovation #ExtractablesAndLeachables

  • Ready to elevate your knowledge? We are excited to introduce our 𝗴𝘂𝗲𝘀𝘁 𝘀𝗽𝗲𝗮𝗸𝗲𝗿𝘀 for the 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝘆 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 𝗗𝗮𝘆 𝗶𝗻 𝗛𝗮𝗺𝗯𝘂𝗿𝗴 𝗼𝗻 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟭𝟵𝘁𝗵 – Silvia Scotti, Senior Project Manager, and Simone Bertolacci, Biotech Laboratory Manager at Eurofins BioPharma Product Testing Italy. 🎯 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 𝗧𝗼𝗽𝗶𝗰: Microbiology Trends & Comparison Studies 🗣 𝗧𝗮𝗹𝗸 𝗧𝗶𝘁𝗹𝗲: Rapid Sterility Methods in Pharma: Eurofins Experience with BactAlert for Cellular Products and the New RedOne Technology for Traditional Drug Products 𝗧𝗮𝗹𝗸 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄: Ensuring sterility is crucial in pharmaceutical manufacturing. Eurofins BioPharma Product Testing Italy provides cutting-edge rapid sterility methods that enhance product safety, accelerate release times, and reduce storage costs. This session will cover: 🔹 The advantages of BactAlert and RedOne rapid methods 🔹 Compliance with Eur Ph 2.6.27 and Eur Ph 2.6.1 guidelines 🔹 Faster turnaround times - 7 days for BactAlert and 4 days for RedOne 🔹 Enhanced data integrity and reliability 𝗠𝗲𝗲𝘁 𝘁𝗵𝗲 𝗘𝘅𝗽𝗲𝗿𝘁𝘀: 🔬 𝗦𝗶𝗹𝘃𝗶𝗮 𝗦𝗰𝗼𝘁𝘁𝗶 brings over two decades of experience in pharmaceutical chemistry, having led strategic projects in automation and digitalisation. 🔬 𝗦𝗶𝗺𝗼𝗻𝗲 𝗕𝗲𝗿𝘁𝗼𝗹𝗮𝗰𝗰𝗶 specialises in biosafety and molecular biology, overseeing sterility testing and microbiology labs for biologics. 📅 Don't miss out! Register today: https://lnkd.in/dbXNeafD #Microbiology #StabilityStudies #RapidSterility #DrugProducts #DrugTesting

    • Kein Alt-Text für dieses Bild vorhanden
  • Eurofins BioPharma Product Testing provides end-to-end CMC testing solutions for the pharmaceutical industry, supporting every stage from raw materials to final product release with global expertise, advanced technologies, and flexible service models to ensure regulatory compliance and product quality. Partner with Eurofins and ensure compliance, efficiency, and quality. Get in touch now! 📧Contact us: PharmaTesting@BPT.Eurofinseu.com 🌐: www.Eurofins.com/BPT 

    👩🔬 Eurofins BioPharma Product Testing offers complete CMC Testing Services for the Bio/Pharmaceutical industry, including all starting materials, process intermediates, drug substances, drug product, packaging, and manufacturing support through our broad technical expertise in Biochemistry, Molecular & Cell Biology, Virology, Chemistry and Microbiology. 🌍With a global capacity of more than 200,000m2 and 46 facilities located in over 22 countries, our network of GMP laboratories and vast experience allow us to support projects of any size from conception to market. We offer three unique service models: -Eurofins PSS Insourcing Solutions® -Full Time Equivalent (FTE) -Traditional fee-for-service 📧Contact us: information@bpt.eurofinseu.com 🌐: www.Eurofins.com/BPT 𝐂𝐡𝐨𝐨𝐬𝐞 𝐞𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲. 𝐂𝐡𝐨𝐨𝐬𝐞 𝐐𝐮𝐚𝐥𝐢𝐭𝐲. 𝐂𝐡𝐨𝐨𝐬𝐞 𝐄𝐮𝐫𝐨𝐟𝐢𝐧𝐬 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐓𝐞𝐬𝐭𝐢𝐧𝐠 #eurofins #biopharma #testingforlife

  • 💧 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 & 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝘄𝗶𝘁𝗵 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗪𝗮𝘁𝗲𝗿 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 Pharmaceutical water is a 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗰𝗼𝗺𝗽𝗼𝗻𝗲𝗻𝘁 𝗶𝗻 𝗱𝗿𝘂𝗴 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴, and its quality directly impacts 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝘀𝗮𝗳𝗲𝘁𝘆. At Eurofins BioPharma Product Testing Germany, our expert teams provide 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝘄𝗮𝘁𝗲𝗿 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀 to ensure your processes meet 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 and maintain the 𝗵𝗶𝗴𝗵𝗲𝘀𝘁 𝗹𝗲𝘃𝗲𝗹 𝗼𝗳 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲. Our services cover the entire water lifecycle, from source to final use, ensuring compliance with 𝗚𝗠𝗣, 𝗨𝗦𝗣, 𝗘𝗣, 𝗮𝗻𝗱 𝗝𝗣 requirements. 🔍 𝗞𝗲𝘆 𝗙𝗼𝗰𝘂𝘀 𝗔𝗿𝗲𝗮𝘀: • 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 – Detecting contaminants such as bacteria, endotoxins, and biofilms. • 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 – Monitoring conductivity, TOC, and elemental impurities. • 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 & 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 – Supporting ongoing compliance with periodic testing and risk assessment. With our 𝘀𝘁𝗮𝘁𝗲-𝗼𝗳-𝘁𝗵𝗲-𝗮𝗿𝘁 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 𝗶𝗻 𝗚𝗲𝗿𝗺𝗮𝗻𝘆, we are committed to delivering precise and reliable results to help our clients ensure product safety and regulatory compliance.   🧪 𝗪𝗵𝘆 𝗖𝗵𝗼𝗼𝘀𝗲 𝗘𝘂𝗿𝗼𝗳𝗶𝗻𝘀? ✔ Extensive experience in pharmaceutical water analysis ✔ GMP-certified and FDA-audited facilities ✔ Tailored testing solutions to meet your specific needs Focus on your core business and let us help you manage the temporary increase in water samples. Get the immediate support of our experienced team and 𝗿𝗲𝗱𝘂𝗰𝗲 𝘆𝗼𝘂𝗿 𝗰𝗮𝗽𝗶𝘁𝗮𝗹 𝗶𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁, 𝗺𝗮𝗶𝗻𝘁𝗲𝗻𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗿𝗲𝘀𝗼𝘂𝗿𝗰𝗲 𝗰𝗼𝘀𝘁𝘀 𝘄𝗵𝗶𝗹𝗲 𝗲𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝗱𝗲𝗮𝗱𝗹𝗶𝗻𝗲𝘀 𝗮𝗿𝗲 𝗺𝗲𝘁. 📩 Get in touch with our experts today to learn more about our pharmaceutical water testing services and how we can support your compliance journey: PharmaTesting@BPT.Eurofinseu.com 🌐 https://lnkd.in/g2mzr6Ut     #PharmaceuticalWater #QualityAssurance #GMPCompliance #PharmaTesting #Microbiology #ChemicalAnalysis #DrugDevelopment #RegulatoryCompliance #GMP #FDA

    • Kein Alt-Text für dieses Bild vorhanden
  • 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗶𝗻 𝗟𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 Environmental monitoring in laboratories is a crucial aspect of quality control and regulatory compliance. Ensuring a controlled environment helps maintain the integrity of laboratory processes and guarantees high-quality standards. Eurofins BPT Germany offers comprehensive environmental monitoring services to support laboratories in meeting these requirements. 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 Particle monitoring focuses on tracking airborne particle concentrations to ensure compliance with cleanroom classification standards. This process is essential for verifying cleanroom classifications and assessing air cleanliness in controlled environments. Microbiological monitoring plays a vital role in detecting microbial contamination, such as bacteria and mold, which can pose potential risks to laboratory environments and products. The monitoring process involves: • 𝗖𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗼𝗳 𝗮𝗶𝗿𝗯𝗼𝗿𝗻𝗲 𝗺𝗶𝗰𝗿𝗼𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗺𝘀 using active air samplers or sedimentation plates • 𝗦𝘂𝗿𝗳𝗮𝗰𝗲 𝗰𝗼𝗻𝘁𝗮𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 testing through contact plate sampling to detect microbial presence on work surfaces 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 Implementing an effective environmental monitoring program offers numerous benefits: • 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Ensures adherence to GMP, ISO, and other industry standards • 𝗥𝗶𝘀𝗸 𝗠𝗶𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻: Early detection of contamination allows for proactive measures to prevent costly deviations • 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲: Maintaining a controlled environment safeguards the quality of laboratory processes and enhances product integrity • 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁: Data collected through monitoring provides valuable insights for informed decision-making Effective environmental monitoring is essential for regulatory compliance and quality assurance in laboratories. Eurofins BPT Germany specialises in microbiological monitoring services, providing expert support to laboratories aiming to maintain high standards. For further information on our services, please contact us: PharmaTesting@bpt.eurofinseu.com or visit our website: www.eurofins.de/bpt #BioPharma #Microbiology #GMP #ISO

    • Kein Alt-Text für dieses Bild vorhanden
  • We are thrilled to introduce our 𝗴𝘂𝗲𝘀𝘁 𝘀𝗽𝗲𝗮𝗸𝗲𝗿 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 𝗗𝗮𝘆 𝗶𝗻 𝗛𝗮𝗺𝗯𝘂𝗿𝗴 𝗼𝗻 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟭𝟵𝘁𝗵 – 𝗗𝗿. Harmen Hawer, 𝗛𝗲𝗮𝗱 𝗼𝗳 𝘁𝗵𝗲 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝘆 𝗟𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗮𝘁 𝗣𝗔𝗡𝗣𝗛𝗔𝗥𝗠𝗔 𝗚𝗺𝗯𝗛. 🎯 𝗦𝗲𝗺𝗶𝗻𝗮𝗿 𝗧𝗼𝗽𝗶𝗰: 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗹𝗼𝗴𝘆 𝗧𝗿𝗲𝗻𝗱𝘀 𝗮𝗻𝗱 𝗖𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 🗣 𝗧𝗮𝗹𝗸 𝗧𝗶𝘁𝗹𝗲: 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝘀 𝗶𝗻 𝗘𝗻𝗱𝗼𝘁𝗼𝘅𝗶𝗻 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗧𝗮𝗹𝗸 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄: Bacterial endotoxins pose a serious health risk, making their detection a critical quality control parameter in the pharmaceutical industry. In his talk, Dr. Hawer will provide a 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗼𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗲𝗻𝗱𝗼𝘁𝗼𝘅𝗶𝗻 𝘁𝗲𝘀𝘁𝗶𝗻𝗴, covering key topics such as: • The importance of pyrogen and endotoxin testing • Current pharmacopeia guidelines and updates • Performance comparison of different testing methods • Transitioning to sustainable testing solutions Whether you're new to the industry or an experienced professional looking to stay ahead of the latest developments, this session offers valuable insights and firsthand experiences with modern detection systems. 𝗔𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗦𝗽𝗲𝗮𝗸𝗲𝗿: Dr. Harmen Hawer leads the Microbiology Laboratory at PANPHARMA, specialising in quality control for injectable medicinal products. With a PhD in microbiology from the University of Kassel, Germany, his expertise spans microbiological release testing, monitoring methods, and GMP compliance. He has also led technical projects such as the qualification of WFI generation and distribution systems and currently offers consulting services within the pharmaceutical industry. 📅 Don’t miss out! Register today: https://lnkd.in/dbXNeafD #PharmaceuticalIndustry #Microbiology #QualityControl #GMP #EndotoxinTesting #RegulatoryCompliance #PharmaQuality #BioPharma #Pharmacopeia #PyrogenTesting

    • Kein Alt-Text für dieses Bild vorhanden
  • Pyrogens are heat-stable substances from bacteria, fungi, or viruses that can cause fever in humans, posing life-threatening risks in parenteral pharmaceuticals. To ensure patient safety, pyrogen contamination must be tightly controlled. Traditionally, the rabbit pyrogen test (RPT) and bacterial endotoxin test (BET) were standard methods. In recent years, the 𝗠𝗔𝗧 emerged as an 𝙞𝙣-𝙫𝙞𝙩𝙧𝙤 𝗮𝗹𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝘃𝗲, simulating the human immune response. Recognised by the European Pharmacopoeia in 2010, MAT is set to fully replace RPT by July 2025, emphasising its importance in modern quality control.

    Dieser Inhalt ist hier nicht verfügbar.

    Mit der LinkedIn App können Sie auf diese und weitere Inhalte zugreifen.

  • 🚀 Stay Ahead in Stability Testing! Eurofins BioPharma Product Testing Europe just released their special edition newsletter on Storage & Stability – packed with insights and updates you won’t want to miss! 🔍 What’s inside? ✔ A deep dive into Stability Testing Requirements under ICH Q1A (R2) guidelines. ✔ Expert advice on achieving successful stability storage. ✔ Insights into Photostability, Transport Stress, and In-Use Studies for drug products. ✔ Technical secrets to ensure optimal storage conditions. 💡 Whether you’re navigating regulatory requirements or optimising your processes, this newsletter has something for you. 👉 Read the full newsletter here: https://lnkd.in/eKxEs-sV 📩 What’s your biggest challenge in storage and stability? Let’s discuss in the comments! #BioPharma #StabilityTesting #PharmaInnovation #StorageExcellence

    📰 Eurofins BioPharma Product Testing Europe brings you the latest updates in the industry. Starting the year with our special edition newsletter on Storage & Stability, read the full newsletter here 👉 https://lnkd.in/eKxEs-sV Our featured articles are: ◾ Overview of Stability Testing Requirements in ICH Q1A (R2) Guideline ◾ The key to successful stability storage ◾ Photostability Transport Stress and In-Use Studies for Drug Products ◾ Technical secrets to maintain storage conditions 📧To speak with our experts contact us at information@bpt.eurofinseu.com 🌐Discover our GMP services - https://lnkd.in/eMNXZ4Ka #storage #stability #eurofins #testingforlife #pharma

Ähnliche Seiten

Jobs durchsuchen