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Baxter BioPharma Solutions to manufacture Novavax’s COVID-19 vaccine
The agreement is expected to advance the commercial-scale manufacturing of the NVX-CoV2373 to enable it to be distributed across Europe following regulatory approval.
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Manufacturing
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Creating a COVID-19 Safety Toolkit for pharmaceutical businesses
Marta Kalas explains how to develop a COVID Safety Toolkit to ensure pharmaceutical businesses comply with changing regulations.
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Article: Regulatory guidance in designing a CCI testing strategy
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
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Case study: Challenges in manufacturing high value lyophilised oncology drugs
Key features of a custom-made freeze-drying integrated solution.
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COVID-19 vaccine supply chains: LBC’s Tom Swarbrick interviews EPR’s Victoria Rees
Junior Editor of European Pharmaceutical Review, Victoria Rees, speaks with LBC's Tom Swarbrick about the glass vials needed to contain the Oxford-AstraZeneca COVID-19 vaccine.
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On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
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Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
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Why cold chain requirements are not holding COVID-19 vaccines back
Despite the stringent storage conditions required for Pfizer and BioNTech’s COVID-19 vaccine, the need for a return to normal life has levelled the playing field for all candidate prophylactics against SARS-CoV-2.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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Life sciences flow metrology challenges
To realise quality, yield and cost benefits, there is a clear need to develop expertise and capability in the flow measurement and characterisation of pharmaceutical powder and fluid flows within continuous manufacturing processes. Dr Tracy Brown from the TÜV SÜD National Engineering Laboratory in the UK has investigated potential flow…
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Application note: Combined Raman-SEM imaging for pharmaceutical studies
This application note presents correlative Raman Imaging and Scanning Electron (RISE) microscopy as a useful tool for investigating the fine structure and chemical composition of pharmaceutical samples.
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Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
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Application note: Synthesis confirmation for nucleic acid medicines – rapid sequence confirmation using a MALDI-TOF mass spectrometer
Medicines that utilise nucleic acids, such as DNA and RNA which control genetic information, are called "nucleic acid medicines".
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Whitepaper: Beta-glucans in purified water – do they really cause overestimation of endotoxin values?
Over the last century, the bacterial endotoxin test (BET) has evolved to keep pace with modern technology and lab expectations: from rabbit pyrogen testing to Limulus amebocyte lysate (LAL), to current developments with recombinant horseshoe crab coagulation factors.
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Application note: Why extractables and leachables matter
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
