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 RECENT PUBLICATIONS FROM PPD LABORATORIES GMP LAB SCIENTISTS Bacterial Endotoxins Testing of Water-insoluble Drug Substances Read more about bacterial endotoxins testing performed by our GMP lab experts 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 Particle Size Distribution Profiles Read more about the relationship between red and blue light sources to determine particle size distribution profiles 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 Part One: Regulatory Considerations for Cell and Gene Therapies Watch the first video of a five-part series on a CMC roadmap to cell and gene therapy Part Two: Cell and Gene Therapy Prerequisites: Sample Prep, Protein Characterization Watch the second video of a five-part series on a CMC roadmap to cell and gene therapy Part Three: New Analytical Tools for Cell and Gene Therapy Watch the third video of a five-part series on cell and gene therapy Part Four: Data Automation for Cell and Gene Therapy Watch the fourth video of a five-part series on cell and gene therapy Part Five: Transfer of Bioanalytical Methods to the GMP Lab for Cell and Gene Therapy Watch the final video of a five-part series on cell and gene therapy Overview: Extractables and Leachables Testing Watch the first video in this four-part series on extractables and leachable testing How to Design an Extractables and Leachables Program Suitable for Your Drug Product Watch the second video in this four-part series on extractables and leachables testing Extractable and Leachable Testing Methods: Including Special Case Compounds Watch the third video in this four-part series on extractables and leachables testing Extractable and Leachable Compounds, Commonly Used and Detected from Polymer Materials Watch the fourth video in this four-part series on extractables and leachables testing GENERAL INFORMATION 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
