GMP Laboratory Resources Our Solutions PPD Laboratory Services GMP Lab GMP Laboratory Resources Industry Best Practices Development Strategies for Cell and Gene Therapy Methods Download this article to read about the reevaluation of bioassay methods due to an increased number of regulatory filings Meeting Extractables and Leachables (E&L) Expectations Explore how to best comply with evolving expectations in the E&L space in this PharmTech issue Extractables and Leachables – Detecting the Unknown with Extractables & Leachables Analysis Learn about the challenging landscape of extractables and leachables analysis in this Drug Development article RECENT PUBLICATIONS FROM PPD LABORATORIES GMP LAB SCIENTISTS N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to other Dosage Forms Explore insights into risk management processes, regulatory considerations, and analytical “tips” in this AAPS PharmSciTech article Stability Testing of Protein Therapeutics Using Dynamic Light Scattering (DLS) Learn more about our GMP lab’s work with DLS in this BioPharm International issue Extractables and Leachables – Detecting the Unknown with Extractables & Leachables Analysis Learn about the challenging landscape of extractables and leachables analysis in this Drug Development article Bacterial Endotoxins Testing of Water-insoluble Drug Substances Read more about bacterial endotoxins testing performed by our GMP lab experts Predicting Extractables and Leachables (E&L) From Container Stoppers Explore how our GMP E&L team uses data from migration kinetics studies Determining Water Content With a Novel Karl Fischer Titration Approach Download this article that outlines a new approach to testing water content in biologics The Limits of Light Obscuration Learn more about light obscuration testing for sub-visible particle quantification in this PharmTech issue Tech TalkS Tech Talk Series: A CMC Roadmap for CGTs Watch the full Tech Talk series on CMC roadmap to cell and gene therapies Tech Talk Series: Extractables and Leachables Watch the full Tech Talk series on extractables and leachables GENERAL INFORMATION Novel RNAi Therapy Asset Acceleration Case Study Explore how our GMP lab in Athlone, Ireland helped accelerate product dossier submission PPD Laboratories GMP Lab Blog Posts Learn more about our GMP Lab from the experts Nitrosamines Analysis Read more about leveraging extensive experience, large testing capacity and leading-edge instrumentation in this case study mRNA Replacement Therapeutics Analytical Capabilities Explore our comprehensive services for mRNA replacement therapeutics
