whitepaper
Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
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QA/QC
whitepaper
Technical paper: Low risk frozen distribution of SU bags for bioprocessing
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
whitepaper
Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
article
QA/QC Raman & RMM In-Depth Focus 2021
In this in-depth focus, discover how Raman spectroscopy is used by Bristol-Myers Squibb to identify counterfeit pharmaceuticals and the role of artificial intelligence in rapid microbiological method development.
whitepaper
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
article
European Pharmaceutical Review Issue 6 2021
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
whitepaper
Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
podcasts
EPR Podcast Episode 7 – Collaboration in ATMP development – Jérôme Larghero and Julien Textoris, bioMérieux
How important is collaboration in ATMP development? What can be done to expedite ATMP manufacturing and release? Find out about all this and more in this podcast with bioMérieux.
whitepaper
Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
whitepaper
Case study: Results from bridging data management gaps
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
whitepaper
Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
whitepaper
Brochure: Simplify your compliance process
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
whitepaper
Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
news
Novel platform technology to enhance in-process monitoring of cell biomanufacturing
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
whitepaper
Application note: Impurity analysis of L-aspartic acid and glycine
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
