It has been a busy beginning of the year for Danaher’s Life Sciences segment. In January, the business reported 2020 revenues of $10.6 billion, representing 47% of the total revenues of science and technology conglomerate Danaher. The Life Sciences unit such as biopharmaceuticals and COVID-19 vaccines. In 2020, the pharmaceutical end-market represented approximately 25% of the company’s total revenues, and the majority of Danaher Life Sciences’ sales.
To serve the pharmaceutical end-market, Danaher Life Sciences provides solutions for testing at every stage of a drug’s life cycle, from discovery and development, to clinical testing and manufacturing. Complex biological substances must be thoroughly and continuously analyzed and characterized. Drugs work by interacting with the body’s proteins and cells. Thus, numerous analytical techniques are used to study and optimize these interactions to ensure drug candidates and the final product are effective and safe.
A key analytical technique for studying proteins is mass spectrometry (MS). SCIEX, part of Danaher Life Sciences, is one the largest providers of MS systems. Molecular Devices, also part of Danaher Life Sciences, is a leading supplier cell-analysis instrumentation. Recently, each company made major announcements that add new systems to grow Danaher Life Sciences’ stable of solutions for biopharmaceutical analysis, particularly for biologic drugs, the fastest growing sector of the drug market.
Blaze iCIEF System
On January 21, SCIEX announced the purchase of Intabio, the developer of the Blaze iCIEF (imaged capillary isoelectric focusing) system for separating and characterizing proteins prior to analysis by MS. iCIEF profiles proteins by measuring their electrical charge.
The technology is necessary to ensure the proper production of biologic drugs. “Due to the nature of their production, biotherapeutics are difficult to manufacture. Growth conditions, purification protocols and formulation requirements can introduce unintended modifications into the protein structure that alter efficacy and toxicity,” explained Lena Wu, PhD, CEO and Co-founder of Intabio. “Because of the complexity of the bioproduction process, frequent testing is required to determine and monitor the drug product quality. iCIEF provides a critical measure of quality throughout the development and manufacturing of biotherapeutics by offering rapid, robust and high-resolution charge variant analysis.” Charge variants are a measure of protein heterogeneity.
The Blaze system provides key advantages over other iCEIF systems, including speed, according to Mani Krishnan, Vice President & General Manager, CE & BioPharma, at SCIEX. “Blaze is unique in that it is the first and only system to fully integrate iCIEF with in-line mass spectrometric characterization to provide a fully automated and rapid analysis of the intact biotherapeutic drug that can be completed in 15 minutes per sample.”
As Dr. Lu put it, “Blaze accelerates biotherapeutic development by transforming a process that used to take up to several weeks down to a few minutes.” This is made possible by Blaze’s microchip technology, enabling faster analysis of smaller volumes, and integrated sample preparation and MS delivery for high resolution and greater efficiency compared to other techniques for charge variant analysis.
ImageXpress Confocal HT.ai High-Content Imaging System
On January 25, Molecular Devices announced new technology to advance cell analysis. The company launched the ImageXpress Confocal HT.ai High-Content Imaging System. Molecular Devices President Susan Murphy called the system, “our next generation premium high-content imaging system.” High-content imaging systems enables rapid screening to identify and measure the effects of biological substances, such as drug compounds, on cells using imaging.
The new system incorporates artificial intelligence via the IN Carta software to provide more sophisticated data processing and even predictive capabilities. “That allows us to really leverage machine learning for all the data that we’re getting [from the system] to enable image analysis and the informatics on the backend,” noted Ms. Murphy. “So really increasing the speed, shortening the discovery time, [and] reducing the burden on the researchers to be able to deliver high-quality images.” Examples of machine learning applications she gave included cell classification and analysis of cell behavior.
The system also provides advantage for researchers working with spheroid or organoid assays, a type of 3D cell assay that more accurately mimics physiological conditions of the cell and tissue compared to traditional assays. Features of the ImageXpress Confocal HT.ai High-Content Imaging System especially applicable to such research are increased throughput and multiplexing as well as enhanced image reproducibility.
Ms. Murphy cited “cell painting”’ as a new method for studying cells that can benefit from these advancements. “It’s a high-content, multiplex, image-based assay. So customers are able to label different components of the cell and basically provide a fingerprint of that cell,” she commented. “What people are wanting to do with cell painting is really look at imaging over time or after a treatment and look at changes.”