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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This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
Discover why pharmaceutical companies should consider aggregation as the next step towards supply chain drug traceability.
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.
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
In this article, Robert Newman and Tom Fletcher explore how the bioprocessing industry has changed in the last 50 years and where the future may lead…
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…
With global supply chains under stress due the pandemic, European pharma companies are increasingly looking for alternative supply channels.
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.
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
The global generics drug market is anticipated to grow to $574.63 billion by 2030, owing to the increasing application of robotic process automation, branded medicine patent expiries and the rising prevalence of chronic diseases.
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.