Welcome to the Sixth Edition of the Biosynth Bulletin

Stay ahead in the life sciences industry with our updates on the latest developments and key events to mark on your calendar.

In the News

A round-up of the latest developments from across our industry

• The FDA has cleared IceCure Medical's XSense Cryoablation System, a next-generation minimally invasive device using liquid nitrogen, to destroy tumors and lesions across various medical fields.
• India is facing its worst outbreak of Chandipura virus in over 20 years, with at least 32 deaths, mostly children and teenagers. Over 80 people have been infected in Gujarat, with cases also reported in neighboring states. Although there is currently a low chance of an outbreak, the situation is being closely monitored.
• The MHRA has approved the first generic versions of raltegravir, an antiviral medicine used in combination with other drugs to treat HIV in adults and children. Raltegravir generic medicines have been shown to be bioequivalent to the reference medicine, Isentress, meaning they offer the same benefits and potential side effects.

Top Reads

• A 14-year-old boy in Kerala, India, has died from Nipah virus, a deadly brain-swelling illness with no cure or vaccine. Sixty people who may have come into contact with the boy are considered high-risk. Authorities have set up committees to identify and isolate potentially infected individuals. Nipah virus has caused previous outbreaks in Kerala and other countries in the region and continues to be on the WHO list of "pathogens... prioritized for R&D in public health emergency contexts."

• Scientists in South Africa are injecting rhino horns with non-toxic radioactive isotopes to deter poaching by rendering the horns unusable and trackable at borders, a new initiative from the University of the Witwatersrand. The Rhisotope Project aims to make horns unfit for consumption and easily detectable at borders using existing radiation detection equipment. If successful, this method may be applied to other endangered species. The project prioritizes animal safety and involves close monitoring of the rhinos' health.
• Researchers at the University of Illinois have published a novel Gram-negative-specific antibiotic (lolamicin) targeting the lipoprotein transport system, demonstrating potent efficacy against over 130 multidrug-resistant clinical isolates in preclinical models while preserving the gut microbiome. This selective mechanism exploits low sequence homology of the target in pathogens versus commensals, offering a promising strategy for developing microbiome-sparing antibiotics.
• Potent hallucinogen Psilocybin temporarily dissolves brain networks. Profound changes in brain activity shed light on the potential neurobiological mechanisms underlying psilocybin's therapeutic effects. Psilocybin disrupts neural synchrony within a region associated with introspection and self-awareness. Notably, this disruption persists in the communication between key regions crucial for our sense of time, space, and self.

• Researchers at the Indian Institute of Science have created an enzymatic platform that converts inexpensive fatty acids into 1-alkenes, a type of hydrocarbon that shows promise as a sustainable biofuel. These biofuels can be used alongside existing fuels and could be mass-produced using microorganisms.

Featured: Lift the Lid on Reproducibility

While we all know life is a mixed bag, that is deeply unhelpful when it comes to consistent data. In our featured topic this month, we highlight a few focussed areas where reliability and reproducibility can be an issue.

A well-known survey of 1,500 scientists found that more than 70% of researchers had tried and?failed to reproduce another scientist's experiments, and more than half had failed to reproduce their own experiments. While no one wants to publish negative data, if we are to improve these statistics, we will require reporting?the lack of consistency to ultimately improve the standard of research.

• A recent systematic review examining the effect of antiviral medications on long-COVID risk found conflicting results despite stringent inclusion criteria and quality assessments. Of the seven studies meeting the criteria, two investigated Nirmatrelvir/Ritonavir and three investigated Remdesivir, with significant disagreements on their effectiveness in preventing long-COVID. This inconsistency underscores the challenges in reproducibility within scientific research.

• Inconsistent characterization of complex biological products, particularly polysaccharide-based vaccines, pose challenges in ensuring consistent manufacturing and efficacy. The ability to map epitopes provides a functional understanding of the critical residues involved, it can aid in the?selection of antibodies, IP protection and FDA/EMA approval. Dr Freedberg and colleagues at the FDA have utilized advanced NMR spectroscopy to analyze polysaccharide structures and identify key features for immunogenicity. This characterization, combined with computational modeling, allows for better quality control in vaccine production, highlighting the importance of understanding and replicating even subtle molecular details for consistent vaccine efficacy and safety.
• Numerous studies in the last few years have highlighted the challenges of enzyme immunoassays (EIAs) in detecting SARS-CoV-2 antibodies and discriminating between high and low-neutralizing antibody (nAb) titers. Significant variability was found in the assays' performance. John Hopkins University researchers found significant variability in the performance of different commercial antibody tests. While the Roche and Abbott assays were highly accurate in detecting antibodies, the Roche assay was less effective at differentiating high nAb titers. This could lead to discrepancies in seroprevalence estimates and impact public health decisions.

• Despite being the clinical standard for HER2 assessment in breast cancer, the Ventana 4B5 immunohistochemistry (IHC) assay's reliability and reproducibility have not been thoroughly validated in real-world settings. A collaboration from the Yale School of Medicine, involving 18 pathologists from 15 institutions, found substantial discordance in HER2 IHC scoring. While the assay remains valuable for identifying HER2-positive cases, its discordance in assigning HER2-low or HER2-negative status highlights its limitations for guiding emerging HER2-low therapies.
• Fetal bovine serum (FBS), a common cell culture supplement, introduces significant variability in research due to its undefined composition. Research at the Centre for Molecular and Nanomedical Sciences demonstrated that different brands of FBS, even from the same producing regions, can significantly influence the baseline expression of inflammatory factors like IL-8 in epithelial cells, attributed to differences in endogenous small molecules and their interaction with cellular signaling pathways. While human platelet lysate (PL) and platelet lysate serum (PLS) offer comparable alternatives for specific cell types, widespread adoption of serum-free media remains limited despite extensive research. This is largely due to the commercial value of FBS and ethical concerns, with viable alternatives like bovine platelet lysate (bPL) and animal-free chemically defined options only recently emerging, signaling a potential shift in cell culture practices.

Events

Where we're going to be

? CMC (Suzhou, China) 15th August - 16th August 2024 Booth C-A01

? ACS (Denver, Colorado, USA) 18th August - 21st Aug 2024 Booth 1603

? 37th EPS (European Peptide Symposium) and 14th IPS (International Peptide Symposium) (Florence, Italy) 25th August - 29th Aug 2024 Booth 27

Check out all our upcoming events.

That's it for this month. See you in next month's edition.

Remember to follow us on Twitter, and be sure to visit our website.

You can also get more news from Biosynth by subscribing to our mailing list.

Youtube | Instagram | LinkedIn