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ENDONEXT™ The evolution of endotoxin testing
With Recombinant Factor C (rFC), we’re making Endotoxin testing faster, easier and more ecologically friendly by mimicking nature, not exploiting it.
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Analytical techniques
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NICE argue for more histology-independent cancer drug evidence
Staff at NICE have co-authored a paper which suggests that new, histology-independent cancer treatments require more clinical evidence before approval recommendation by the institution.
Whitepapers/App Notes/Posters
Application note: A CMC Development Decision Support Tool for Batch Genealogy Management
Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
news
The Advance Value Framework: evaluating the benefits of novel medicines
Researchers have proven their methodology for drug benefit evaluation to be effective as a decision support tool in a study with several European drug evaluation bodies.
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Funding for AI in drug development, clinical trials and information synthesis hits $5.2bn
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
Whitepapers/App Notes/Posters
Whitepaper: Complex Generic APIS: A Primer
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
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Genotoxic impurities in pharmaceutical products
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
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Exploring Raman: a non‐invasive analytical approach
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Whitepapers/App Notes/Posters
Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)
THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.
Whitepapers/App Notes/Posters
Whitepaper: Innovative analytical techniques for bioprocess investigation
WITH THE RISE of metabolites/molecules production using complete living cells or their components (bacteria, enzymes, chloroplasts, etc), which is also termed bioprocessing, it has become increasingly important to control the different production steps and analyse the different biological materials.
Whitepapers/App Notes/Posters
Application note: Identifying microparticles with Raman imaging
Microparticles can be found everywhere, from pigments in paint and titanium dioxide in sunscreen to microplastics in water.
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Application Notes & Whitepapers 2019
Industry experts share their latest research and developments in pharma.
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Expert view: The future of biologics quality – multiple attribute methodology
Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
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QA/QC & Analytical Techniques In-Depth Focus 2019
This in-depth focus includes features that examine how microbiologists can advance their methods of study, discuss the regulatory guidelines regarding genotoxic impurities and explore Raman spectroscopy as a non-invasive analysis technique.
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European Pharmaceutical Review Issue 6 2019
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.