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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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QA/QC
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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.
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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.
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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…
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ebook: Spectroscopy and materials characterisation applications for pharmaceutical analysis
In this ebook, discover innovative solutions for three core areas of drug development: drug formulation, scale-up and analysis with hot melt extrusion; quality control and validation using microscopic and spectroscopic instruments; and instrumentation for nucleic acid quantification and qualification.
webinar
A holistic strategy to ensure container closure integrity of sterile vials
11 February 2021 | By Lighthouse Instruments
Watch our on-demand webinar where we describe a more science-based holistic approach to ensure CCI; a framework that includes robust design and qualification of the process and the implementation of appropriate process controls is required.
whitepaper
Brochure: RP-HPLC columns for proteins and peptides
The Discovery® BIO wide pore reversed-phase HPLC columns and capillaries provide sensitive, stable, efficient and reproducible separations.
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Application note: LC-MS/MS method to analyse 20 amino acids
This application note outlines an LC-MS/MS method for analysing all 20 amino acids, without derivatisation, utilising the Supel™ Carbon LC column.
webinar
Data integrity and digital workflow guidance in a contemporary pharma lab
9 February 2021 | By Sartorius
During this on-demand webinar we discuss how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations.
webinar
Implementing Pharma 4.0 on water systems – FAQ for increasing efficiency with TOC and conductivity
5 February 2021 | By SUEZ – Water Technologies & Solutions
In this on-demand webinar you will learn from two experts with deep expertise in online monitoring, UPW, RTT, TOC, conductivity, cleaning validation and Pharma 4.0.
news
EMA begins rolling review of Novavax’s NVX-CoV2373 COVID-19 vaccine
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
