Partnership between Sartorius and Waters Corporation for easier clone selection and bioprocess development

Growing demands for analytical data

Waters Corporation and Sartorius recently announced a collaboration aimed at providing bioprocess experts with direct access to high-quality mass spectrometry data to accelerate development and improve the accuracy of the biopharmaceutical process. The goal of the collaboration with this world-leading company specializing in chromatography, mass spectrometry and thermal analysis is to implement the BioAccord ™ LC-MS system (new bioprocessor analyzer) with Sartorius Ambr® multi-parallel bioreactor systems to provide mass spectrum information on drugs, related analytes and cell culture media. The combination of these systems will greatly speed up and improve the accuracy and speed of tasks - from clone selection to bioprocess optimization.

Waters and Sartorius share a commitment to biopharmaceutical customers to solve their problems with the very best process and analytical tools. Clone selection and process development can benefit significantly from versatile mass spectrometry data that can help bioprocess engineers accelerate workflow and increase determination in making critical decisions.

Davy Petit, Senior Director of Global Pharmaceutical and Biomedical Research Business, Waters Corporation

The collaboration of the two pharmaceutical giants is not at all surprising, given a recent Evaluate Pharma report, according to which biopharmaceutical requirements are one of the fastest-growing segment in the overall pharmaceutical market. The strong growth of this area, encourages an unprecedented speed with which very complex new biological drugs are coming to market. As a consequence, biopharmaceutical manufacturers are demanding more analytical data than ever before on drug properties and bioprocess efficiency to enable the development of new, better and more affordable drugs.

Fast access to mass spectrometry data

Biological drugs are made by living cells in bioreactors like the Sartorius Ambr high throughput bioreactor system. At the conclusion of the cell culture process, the proteins are separated from the cell residue and samples are sent to a central laboratory to await testing by analytical scientists using specialist liquid chromatography - mass spectrometry (LC-MS) instruments. It’s not uncommon for the process to stretch across 2-4 weeks or more depending on the workload, equipment availability, priorities, and staffing levels of the central analytical laboratory.

The combined offering from Sartorius and Waters aims to shorten the process from what can take over a month to two days or less, while giving more control to bioprocess scientists to obtain robust mass spectrometry data for drug substance and cell culture media samples. The industry-leading range of Sartorius Ambr multi-parallel bioreactors has been developed to take scientists through the early steps of their upstream process from cell selection, through to process optimization. The Waters BioAccord System is a small footprint LC-MS instrument designed as an easy-to-operate, at-line benchtop bioprocess analyzer. Its pre-defined analytical methods, guided workflows, auto-calibration, and auto-tuning features allow those without any mass spectrometry experience to obtain high-quality mass spectral data within minutes.

Through this collaboration, companies will work on the possibilities of adapting the method of analytical mass spectrometry to new modalities and including their use in bioprocess monitoring, process control and measurement of critical quality attributes (CQA).

Read the official notice of the manufacturer here.