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Downstream processing is an integral part of the production process of biopharmaceuticals and contributes quite significantly to the overall productivity and product quality, as well as to processing costs. Melanie Diefenbacher of Genedata provides a comprehensive overview of downstream processes, highlighting several challenges and the importance of investing into automation…
The field of regenerative medicine – an area promising a revolution in 21st century healthcare – has been enabled by rapid scientific advancements in recent years. There is a growing need for a new generation of therapeutic products, made more severe by the global shortages of organs available for transplantations.…
In this in-depth focus are articles on what manufacturing challenges must be overcome for regenerative medicine to reach its potential and how automation and digitalisation ensure efficient bioprocessing.
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
This in-depth focus includes articles detailing five important considerations for European companies entering the US biosimilar market and explaining why virally vectored DNA and mRNA vaccines could prevent the spread of COVID-19.
A study that analysed QA/QC incidents at several biomanufacturing plants has revealed how companies can best hope to detect and mitigate virus contamination.
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Eurofins, Associates of Cape Cod, Inc. (ACC), SGS Life Sciences and Nelson Labs showcase their unique testing services and discuss how they stand out from the competition.
The articles in this in-depth focus discuss the importance of biosimilars and how liquid chromatography can be used to ensure the purity of lipid-based nanoparticles for drug delivery.
A new method has been developed by researchers which they say could allow E. coli and other pharmaceuticals to be produced in space, using shearing force and a viscometer.
Researchers have discovered low-cost preservatives that enable freeze-dried cellular machinery to retain full activity when stored at room temperature for cell-free biotechnology.
Researchers have shown that the CALB lipase enzyme can be used to produce macrocycles of a specified shape using biocatalysis.
The US NIH has initiated a clinical trial for remdesivir and two pharmaceutical companies will work together to manufacture antibody treatments to tackle the coronavirus.
Chemists have synthesised a single catalyst, able to perform multistep cascades of chemical reactions to produce a pharmaceutical product.
