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

Publications from PPD Laboratory services’ GMP lab scientists

Instrument-based testing: A more modern and robust approach to titration

Read this Amer Pharm Review article on how autotitrator equipment and methods can overcome subjectivity and manual data entry when quantitating analytes

Use of AUC in AAV Analysis in a GMP Setting

Learn how to set up a suitable workflow in a GMP environment for the data analysis of AAV-based drug samples using AUC to quantify partially-filled capsids

PCR-based analytics of gene therapies using AAV vectors: Considerations for cGMP method development

Learn about the lab assays required to support rAAV development and manufacturing

How can an expert GMP/CMC lab support your rAAV manufacturing process?

Learn one way rAAV products are created and the laboratory assays required to support their development and manufacturing in this infographic

Extractables and leachables – Reliable method for measuring in medical and pharma-grade plastics

Learn about measuring E&L in medical and pharma-grade plastics in this Pharmaceutical Outsourcing 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

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

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

Diverse analytical approaches for complex oligonucleotides

Examine how our Athlone lab uses its experience in oligonucleotide testing to work with challenging compounds and navigate regulatory requirements.

PPD laboratory services GMP lab biosafety capabilities

Read more about our GMP lab expanded testing services to support development of biologics and cell and gene therapies

Plume geometry webinar

Learn more about the examination of processing schemes and inter-analyst variability in this webinar

Key considerations for biotechs using next-generation contract GMP/CMC laboratories

Learn how GMP and CMC labs can help fulfill biotechs' needs with the latest platforms, technologies and instruments in this podcast.

Contract lab of the future

Learn more about choosing next-generation contract GMP/CMC laboratories

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