Given the unprecedented rate at which highly complex new biologics are coming to market, biopharma companies are requiring more upstream analytical data than ever about drug product attributes and bioprocessing efficiency to enable the development of new, better, and more affordable medicines and vaccines, said the partners.
The collaborative effort will combine the Waters BioAccord LC-MS System, as a bioprocess analyzer, with the Sartorius Ambr bioreactor system, with the idea of giving bioprocess scientists both faster and direct access to advanced quality characterization information.
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. Waters says its BioAccord System is a small footprint LC-MS instrument designed as an easy-to-operate, at-line benchtop bioprocess analyzer, allowing those without any MS experience to obtain high-quality mass spectral data within minutes.
Accelerated turnaround time
The partners believe the alliance will accelerate turnaround time for robust data about critical quality and cell culture media attributes, aiding bioprocess scientists in clone selection and process development.
Davy Petit, senior director of global pharmaceutical and biomedical research business, Waters, explained to BioPharma-Reporter how combining the technologies would shorten the process from what can take over a month to two days or less, while also giving more control to bioprocess scientists.
“During upstream clone selection and process development, product quality attributes (PQAs) are measured at fixed intervals and, after sampling, it can take weeks for dedicated analytical support labs, and their LC-MS experts, to release results. This time lag of up to six weeks severely hinders the optimization of the drug substance purity and quantity, as decisions are made based on limited data with long turnaround time.
“Situating the easy-to-use BioAccord LC-MS system in the bioprocessing suite and linking it to Ambr bioreactors essentially ‘cuts out the middleman’ and allows bioprocess scientists to directly measure the PQAs themselves. This approach maximizes drug product quality and yields, while identifying impurities earlier thus, reducing the need for multiple expensive optimization cycles later in the process.”
Mario Becker, head of product management, cell culture technologies at Sartorius, said the closer the partners can bring fundamentally important MS data to the point where it is needed, and the more Ambr samples that can be tested for quality attributes, the better they can provide bioprocess scientists a more complete picture of drug product quality at any point during cell-line, media, and process development. “Eventually, we can envisage such process control, monitoring and product quality testing being fully integrated into the manufacturing environment.”
The two companies are also going to collaborate on opportunities for adapting analytical MS methods to new modalities and incorporating its use in bioprocess monitoring, process control and critical quality attribute (CQA) measurement.