8th April 2021
Transforming Detection at the Point-of-Need with Real-Time Analysis of Pharmaceutical Processes
Analysing chemical reactions in a continuously flowing stream, rather than after batch production is increasingly gaining attention in the pharmaceutical industry. On-line flow reaction monitoring combined with miniaturised mass spectrometry (MS) can provide agile sample detection and identification of active pharmaceutical ingredients (APIs) at the point-of-need, leading to increased productivity and eliminating the risk of waste in the supply chain.
Optimize production in the pharmaceutical supply chain
In the areas of drug manufacturing and vaccines, ensuring a continuous flow of the supply chain can make the difference between life and death situations. Especially in a global pandemic. Both Pfizer-BioNTech and Astrazeneca have experienced production issues, leading to delays in the supply chain.
That’s why it’s vital to implement quality control (QC) and quality assurance (QA) at every stage of the production process. This can be achieved with a flow reactor coupled to a mass spectrometry system, such as the Microsaic 4500 MiD®. Using this specific workflow results in:
- Instant data generation
- Real-time analysis of flow stream chemical composition
- Real-time detection of impurities
- No delays waiting for off-line analysis results
- Improved yield, purity, and reaction selectivity
- Improved efficiency of chemical and biological workflows
A miniaturised MS system installed directly at the point-of-need and connected to a flow reactor to acquire meaningful data takes less than one hour, and essentially brings your laboratory to the sample. Typically, MS analysis is performed off-line, since traditional MS techniques are very expensive, and not designed to be used in an online operation.
Rapid decision making based on real-time flow reaction performance data
In pharmaceutical production, off-line analytical techniques such as sample dilution, preparation, and extraction to a laboratory can be extremely time insensitive. Often resulting in analysis that can’t accurately represent the reaction performance at a particular point in time.
Consequently, the pharma industry is increasingly utilizing miniaturised MS detectors and online dilutors to perform on-line chromatographic analysis of flow reactions in drug manufacturing. Increased productivity and real-time decision making can now take place at the point-of-need, as this system has the ability to:
- Confirm the presence of desired products
- Identify impurities and intermediates
- Determine steady state conditions
- Speed up process optimisation
Identify pharmaceutical by-products in wastewater with mini mass spectrometers
Although on-line flow reaction monitoring is predominantly used in drug manufacturing processes, real-time detection of pharmaceuticals can take place at the point-of-need, such as in water supplies. Assessing the risk and presence of APIs in water and wastewater locations is critical to maintain the health and safety of the public in drinking water, and also to protect the environment. Historically, conventional chromatography laboratory methods have been used to detect contaminants and impurities in water, by bringing a sample to the laboratory for analysis.
Introducing a portable mass spectrometer combined with AI sensors to the point-of-need, offers real-time analysis of target pharmaceuticals and APIs in the water supply. In fact, Microsaic has recently joined the EcoWaterOS consortium, an end-to-end water contamination detection and decontamination solutions provider network, to provide powerful, compact MS systems that enable real-time detection of impurities and APIs in global water systems.
Point-of-need mass spectrometry technology across the pharma industry
Whether you’re maintaining the supply chain of pharmaceutical products or detecting impurities during field-based research, miniaturised MS detectors combined with other on-line flow reaction monitoring are essential for enabling real-time decision making. Across the pharmaceutical industry, there’s an urgent need for mini mass spectrometers that are substantially smaller, lighter, and easily installed at any location.
Get in touch to find out how our chip-based MS technology optimises productivity, lowers running costs, and enables point-of-need detection at any stage of the user’s workflow.