Pharmaceutical Technology Editors

Aizon's Asset Health Application monitoring system


Aizon offers the intelligent, real-time, and proactive Asset Health Application monitoring system. The system is built on Aizon’s good practice-compliant artificial intelligence software-as-a-service platform for life sciences and features a dashboard specifically customized to manage each manufacturer’s unique asset maintenance needs.

The Asset Health application allows manufacturers to leverage predictive power to monitor the health of their assets and, based on the prescriptive data-driven insights that the solution provides, receive advanced warnings on asset conditions to allow them to react and intervene in real-time and keep the production lines up and running.

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Aizon's Asset Health Application system is customized to manage each manufacturer's unique asset maintenance needs.

Application Monitoring System

Linkam Scientific’s RHGen Relative Humidity (RH) controller

Linkam Scientific’s RHGen Relative Humidity (RH) controller offers humidity control between 3% and 95% RH at temperatures from ambient to 85 °C. Relative to past models, it has an upgraded RH sensor and improved connectors, providing environmental control to a variety of Linkam temperature control stages and third-party chambers.

The RHGen allows for precise control of the humidity around a sample without need for an external dry air supply. Accurate humidity control is maintained through close placement of the feedback sensor to the sample block. Magnetic connectors for the bottle enable easy water changing and refilling for users.

The device can be combined with the Inert Gas Regulator, which acts as a regulated pressure interface between the RHGen and an external gas supply to allow inert gasses into the chamber. This allows the RHGen to replicate unique environmental conditions. It can also be used in conjunction with light microscopy, Raman, Fourier transform infrared, and X-ray for further sample characterization.

Linkam Scientific’s RHGen Relative Humidity (RH) controller allows for precise control of sample humidity without need for an external dry air supply.

Relative Humidity Controller

New England Biolabs Luna Probe One-Step RT-qPCR Mix with UDG

New England Biolabs (NEB) Luna Probe One-Step RT- quantitative polymerase chain reaction (qPCR) Mix with uracil-DNA glycosylase (UDG) enables sensitive, linear, real-time detection of target RNA sequences in a room temperature-stable format. When measured in NEB’s “dot in boxes” scoring method—a high-throughput data visualization tool that provides quality scores for qPCR outcomes—the LyoPrime Luna outperformed many competitor products and strongly matched the company’s liquid mix, according to the company.

The lyophilized mix contains murine RNase Inhibitor, deoxynucleoside triphosphate, and a passive reference dye. It incorporates thermolabile UDG, which is well-suited to RNA workflows, as well as deoxyuridine triphosphate to reduce carryover contamination risk between reactions.

New England Biolabs Luna Probe One-Step RT-qPCR Mix with UDG enables sensitive, linear, real-time detection of target RNA sequences.

Lyophilized Master Mix

FDA updated the Emergency Use Authorization (EUA) for sotrovimab on Feb. 23, 2022 to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment.

This update is in response to FDA’s continuous monitoring of how authorized treatments for COVID-19 are affected by changing variants, which currently include the Omicron variant and Omicron sub-variants.

Sotrovimab is still currently authorized in all US regions. The EUA authorizes sotrovimab to treat positive-testing patients who are at high risk for progression to severe COVID-19, including hospitalization or death. Sotrovimab should be administered via IV as soon as possible after a positive viral test for COVID-19 and within seven days of symptom onset. 

FDA will continue to monitor conditions and refer to available information to determine whether use in a geographic region is feasible for authorization.

FDA has revised the Emergency Use Authorization for sotrovimab.

FDA Updates Sotrovimab Emergency Use Authorization

Alexion, AstraZeneca’s Rare Disease group, has closed an exclusive global collaboration and license agreement with Neuroimmune for NI006, the company announced on March 1, 2022. NI006 is an investigational treatment, currently in development to treat transthyretin amyloid cardiomyopathy (ATTR-CM), an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis.

NI006 specifically targets tissue-deposited, misfolded transthyretin, potentially being able to treat patients with advanced ATTR-CM. Heart failure due to ATTR is caused by aging or genetic mutations resulting in misfolded TTR protein and accumulation as amyloid fibrils in the cardiac myocardium. According to the press release, there are an estimated 300,000­–500,000 patients with ATTR-CM worldwide; however, many of those patients remain undiagnosed.

Alexion has been granted an exclusive worldwide license to develop, manufacture, and commercialize NI006. AstraZeneca and Alexion are also investing in multiple other investigational therapies to address cardiomyopathies that can lead to heart failure.

AstraZeneca and Neuroimmune have closed an exclusive global collaboration and license agreement to develop and commercialize NI006.

AstraZeneca and Neurimmune Collaborate on Treatment for Transthyretin Amyloid Cardiomyopathy

BioMed X, a German independent research institute, announced on March 1, 2022 the launch of its new research project ‘Advanced Biomarker Detection for Pharmaceutical Monitoring in the Brain’ (BDB) in collaboration with Boehringer Ingelheim.

The goal of BDB is to develop a continuous monitoring biosensor to detect small-molecule biomarkers in rodent brain tissue to support the development of innovative treatment approaches in precision psychiatry. The BDB project is the fifth collaborative research project between BioMed X and Boehringer Ingelheim, who have worked on projects together since 2014.

“The process of developing active drugs for the treatment of neuropsychiatric diseases involves establishing a robust relationship between the pharmacodynamic effect and the pharmacokinetic parameters of new drug candidates,”said group leader of team BDB, Dr. Khulan Sergelen. “Our main task is the development of a new minimally invasive molecular biosensor, including molecular design and assay development, biocompatible sensor architecture, and optical sensor integration for 

The new project will further strengthen and significantly extend our institute’s expertise and capabilities in the field of neuroscience and sensor development,” added Christian Tidona, founder and managing director of BioMed X. “We are eager to add another success story to our long-term partnership with Boehringer Ingelheim and with this new technology platform we are looking forward to contributing to the discovery of new biology in neuropsychiatric diseases.”

BioMed X and Boehringer Ingelheim have announced the start of a new research project in brain sensor development. 