$PBIO A major challenge in the manufacture of biop

$PBIO A major challenge in the manufacture of biopharmaceuticals is the development of drug formulations that ensure proteins maintain their activity during shelf life and do not aggregate (stick together), since protein aggregation can result in significant issues in patients, sometimes even severe immune reactions up to anaphylactic shock. The joint development work undertaken by PBI and RedShiftBio offers a workflow that allows scientists to study mechanisms of protein aggregation and perturb protein structure "on demand" to promote aggregation events for accelerated stability tests. Such an approach would allow biopharmaceutical companies to test specific chemical formulations that stabilize the protein drug and prevent its aggregation. This should result in both faster development of new drugs as well as improvement in the quality of drugs coming onto the market.

Alexander V. Lazarev, Ph.D., Chief Science Officer of PBI, said: "Our collaboration with RedShiftBio takes advantage of our ability to manipulate protein structure with high pressure and RedShiftBio's precise analytical platform that reports subtle changes in the three-dimensional structure of protein molecules that could lead to protein aggregation. Unfortunately, aggregated protein biologics could train a patient's immune system to recognize and eliminate the drug, so finding appropriate formulations to prevent aggregation is a major task in biopharmaceutical drug development. Moreover, MMS will help us to understand protein folding kinetics in our BaroFold platform, which uses high pressure to shape recombinant proteins into their active and stable conformations in biomanufacturing process development."

Julien Bradley, Chief Executive Officer of RedShiftBio, commented: "Accelerated stability studies are an important component of drug development and regulatory submissions. They are commonly performed today using methods that require elevated temperatures to exhibit their propensity to aggregate. However, temperature-sensitive formulations can't be subjected to high temperature-based accelerated stability studies, but must be tested in real time, which significantly prolongs the development process. Since PCT-enhanced MMS high pressure perturbation does not require the use of elevated temperature, accelerated stability testing in formulations development could potentially be reduced to weeks, if not days. Consequently, the PCT-enhanced MMS platform could potentially be used to achieve new drug approvals in significantly less time than required today."

Roxana McCloskey, PBI's Global Director of PCT/BaroFold Sales and Marketing, commented: "This new alliance is an excellent complement to our existing play with other protein analysis tools, such as NMR, EPR, optical spectroscopy, and mass spectrometry, as well as biomanufacturing process development and biopharmaceutical quality control. The PCT-enhanced MMS platform provides yet another powerful method for accelerating the development of protein therapeutics. It also enables PBI to further expand our reach into the large and rapidly growing protein therapeutics market. Together with our colleagues at RedShiftBio, we will be focusing a large amount of sales & marketing efforts in this area during the second half of 2020. We believe this focus will result in both increased sales and new customers for PBI."

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