GMP Laboratory Resources

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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
PPD scientists predict the amounts of extractables and leachables (E&L) from container stoppers based on mathematical models.
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

Mycoplasmas-biosafety-GEN-2024-card
The Time Is Now for New Biosafety Testing Services
Experts discuss the need to test for mycoplasmas and replication-competent viruses in this article
Instrument Based Testing: A More Modern and Robust Approach to Titration
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
AUC-in-AAV-GMP
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
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
PPD Researcher in clinical lab.
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
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
girl using inhaler
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

Central lab Accelerating clinical trials
Tech Talk series: A CMC roadmap for CGTs
Watch the full Tech Talk series on CMC roadmap to cell and gene therapies
GMP Extractables & leachables series
Tech Talk series: Extractables and leachables
Watch the full Tech Talk series on extractables and leachables

General information

Cell and Gene Therapy (CGT) Analytical Capabilities
PPD® Laboratories GMP Lab has extensive analytical capabilities to support CGT product development programs
The role of extractable and leachable testing in GMP labs
Download our white paper to explore the critical role of GMP labs in extractables and leachables testing.
PPD-Athlone-Inhalation-GMP-Lab-card
New inhalation capabilities
Learn more about new capabilities for controlled temperature and humidity testing of inhaled biologics
Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics
Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics
Watch this video to learn more about rapid mycoplasma testing
repiratory-drug-development-ebook-card
Respiratory Drug Development eBook
This comprehensive guide covers the latest breakthroughs, challenges, and future trends in respiratory drug development
Diverse Analytical Approaches for Complex Oligonucleotides
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 GMP Lab
Biosafety capabilities and expertise
Advanced mycoplasma and viral testing services to support development of biologics and cell & gene therapies
Plume Geometry Challenges Webinar
Plume geometry webinar
Learn more about the examination of processing schemes and inter-analyst variability in this webinar
Contract lab of the future
Learn more about choosing next-generation contract GMP/CMC laboratories
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Novel RNAi Therapy asset acceleration case study
Explore how our GMP lab in Athlone, Ireland helped accelerate product dossier submission
Nitrosamines Analysis: Leveraging extensive experience, large testing capacity and leading-edge instrumentation
Nitrosamines analysis
Read more about leveraging extensive experience, large testing capacity and leading-edge instrumentation in this case study
mRNA therapeutic and analytical lab technician
mRNA replacement therapeutics analytical capabilities
Explore our comprehensive services for mRNA replacement therapeutics
PPD Laboratories’ GMP lab blog posts
Learn more about our GMP lab from the experts

Learn more about PPD Laboratory services GMP lab

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