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

GENERAL INFORMATION

mRNA Replacement Therapeutics Analytical Capabilities

Explore our comprehensive services for mRNA replacement therapeutics