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The PAT-based approach is the first of its kind to prevent membrane fouling when using a robust single-pass tangential flow filtration (SP-TFF) operation in bioprocessing, according to a paper.
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
Trends such as sustainability and technological advances like AI are helping to boost the microbial fermentation technology market, a report says.
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
The study observed that using a modified vacuum filtration system assisted in the filtration of large volumes of bacterial cultures, removing the need for centrifuges.
The critical need to rapidly develop new biological therapeutics was emphasised during the COVID-19 pandemic, prompting a sea-change in the speed with which development of complex biological medicines occurs. In parallel, the increasing demand for new molecular formats, such as multi-specific antibodies, to tackle a wide range of disease modalities…
China’s WuXi Biologics - a contract research, development and manufacturing organisation (CRDMO) - has launched a facility in Hangzhou for cGMP manufacturing of microbial-derived products.
A paper shows implementing riboregulated switchable feedback promoters enables cells to produce the precursors for potentially toxic chemotherapeutic and anti-malarial drugs.
A new analysis suggests that Europe and North America will capture more than 80 percent of the $9.3 billion market by 2030.
Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells.
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
The Burkholderia cepacia complex (BCC) species are a group of gram-negative, rod-shaped bacteria that have been shown in recent years to be of concern for patients, and thus for manufacturers of drugs and products that contribute to patient health...
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics...
This poster discusses a process for a 12-week clone development process. The process starts in silico, and progresses through screening and clone selection in 96-deepwell plates up to five liter shaker flasks...
