This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
Here we describe screening of detergents for release of adenovirus from HEK293 host cells to replace the traditionally used detergent Triton™.
In this study, periodic counter current (PCC) chromatography and straight-through processing (STP) technologies were evaluated in a continuous three-step monoclonal antibody (mAb) purification process.
Buffer preparation is both time- and space-consuming and become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-line conditioning.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
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