GEN-MKT-18-7897-A
Aug 7, 2019 | Blogs, Pharma | 0 comments
Wouldn’t it be great if we really could “get time back” or even “buy time”? When developing pharmaceuticals, it takes years to bring a new therapy to the market due to the linear nature of the process. As the saying goes, “Time waits for no one.” But what if we could do more in the same period, effectively slowing time down? Then we would be in the favorable situation of having time on our hands.
In pharmaceutical development, many new compounds are screened for their effectiveness during the discovery process. The efficacy is determined by various tests to ensure that the compounds are effective and safe. Many analytical technologies, all with different capabilities, are employed to screen the vast numbers of compounds and deliver an analytical determination. Let’s take high-throughput screening (HTS) assays in pharmaceutical development as an example. Have you ever considered that these are potential bottlenecks to sample throughput today? Have you ever thought that the effort it takes to develop and validate an assay is overly time-consuming? Or been concerned that the results from HTS assays have high numbers of false positives/negatives that mean you spend even more time on data evaluation? Then mass spectrometry (MS) based systems could be the way to improve the selectivity of results, gain confidence in the data, and provide the ability to multiplex—allowing you to do more on a single system. But MS-based technology has its pitfalls, too. One potential bottleneck, particularly with MS-based detection, is that it often requires the use of liquid chromatographic (LC) separation to help with the removal of chemical and matrix-related interferences. This enhances compound ionization and thus selective detection, but adds time to the analysis. Up until today, some of the quickest analysis times with MS have been in the region of 1 sample every 15 seconds.
So, have you heard about Acoustic Ejection Mass Spectrometry technology (AEMS) recently introduced at ASMS 2019 by SCIEX? This technology has the potential to surpass the limits of sample analysis throughput and revolutionize HTS in both speed, accuracy, and precision. With the Echo MS system, the speed of analysis can be as fast as 3 samples per second—50 times faster than current MS-based assays. Your current and future high-throughput screening workflows can be transformed with this new frontier in contactless sampling. The Echo MS system combines the pioneering innovations of an Open Port Interface (OPI) and Acoustic Droplet Ejection (ADE) to form an Acoustic Ejection Mass Spectrometry system. Powerful but gentle in its approach, ADE technology is built into a liquid handler. It focuses ultrasonic acoustic energy at the meniscus of a fluid sample to eject small droplets of liquid (between 1 and 10 nL) from microtiter plates wells (96, 384 or 1536) into the OPI. That is where the very accurate droplets are transferred to a SCIEX mass spectrometer ion source for detection using mass analysis. This results in answers at speeds of up to 180 samples/min, or about 260,000 per day. The accuracy and precision of the assays benefit from the capability of mass spectrometry analysis to deliver <5% CV, along with high levels of uptime because of the use of the OPI in combination with the proprietary SCIEX OptiFlow® Turbo V source. Other key benefits include:
Not convinced? Learn More >
Register your interest in AEMS and gain insight into the potential of this new technology over the coming months.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.
In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for minor fragments, and subjective integration.
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