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Modern biologics development relies on the screening of 100s - 1000s of monoclonal antibody (mAb) variants to identify lead development candidates with optimal properties such as affinity, specificity, immunogenicity, and glycosylation.
The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…
As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…
This article shares the results from an evaluation of a novel thermal imaging technology that took place before the initial implementation in a Pfizer manufacturing facility. The manuscript describes the technology and reviews the extensive process used to challenge its inspection capabilities through field testing. Finally, the potential benefits of…
Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.
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…
Due to the high costs associated with drug discovery and the clinical demand for effective drugs, in vitro human cell-based kidney models using renal proximal tubule epithelia are becoming popular tools for early-stage testing. It is increasingly more important that in vitro models of renal drug transport are physiologically representative…
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…
Raman spectroscopy has numerous applications in the pharmaceutical industry, ranging from verification of raw materials to quality control of products. This article explores how researchers are using the technique to aid our understanding of SARS-CoV-2, potentially improving detection speed and methods of analysis.
Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…
Contec ReFIBE: a recycled polyester cleanroom wipe providing a sustainability story in a single-use world.
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.
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.
Medicines that utilise nucleic acids, such as DNA and RNA which control genetic information, are called "nucleic acid medicines".
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.
