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Case study: Oxygen monitoring during shelf life
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
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QA/QC
video
Video: Single versus multilayer film in cold chain bioprocessing
Our video highlights how Aramus™ bag assemblies overcome single-use bag failures at cold temperatures with a new single-layer fluoropolymer material.
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Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
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Resource library: Smart up your lab with EMSURE® products for pharma QC
See how compliant products, unique packaging and smart labels make EMSURE® inorganics and solvents the smartest choice for pharmaceutical analysis.
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Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
article
Effect of moisture variation on the robustness of NIR spectroscopy-based calibration models
NIR spectroscopy is well-known for its sensitivity to water, which can be useful for detecting water variation in the sample matrix. However, for many other applications, water intake of the samples may be an issue and must be closely monitored to gauge the predictive performance of calibration models. This article…
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Brochure: Fast and simple plasma protein binding studies
Supel™ BioSPME 96-Pin Devices vastly outperform current sample preparation techniques for plasma protein binding studies and free fraction analyses.
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Application note: In-process monitoring of headspace oxygen levels
Monitoring headspace oxygen to ensure stability and potency of finished oxygen sensitive product.
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Sourcing of active pharmaceutical ingredients
Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
news
EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
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QA/QC & Analytical Techniques In-Depth Focus 2021
Read this in-depth focus to find out how moisture affects the performance of NIR spectroscopy-based classification models and discover novel mass spectrometry applications for pharmaceutical R&D.
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Regulatory challenges and myths in pharmaceutical 3D printing
Although three-dimensional (3D) printing has been around for some time, many people still underestimate its capabilities. This article addresses the regulatory challenges faced by the pharmaceutical sector and aims to correct some of the most common myths surrounding the technology.
news
EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
whitepaper
Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
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European Pharmaceutical Review Issue 1 2021
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
