With nine products already on the market, bispecific antibodies (bsAbs) are the most commercially advanced of all antibody-derivative biopharmaceuticals. But that isn’t to say that they face no obstacles to success. Indeed, as BPI’s senior technical editor finds in her review of recent literature and conference proceedings, the details of production and processing still confound many bsAb developers. With dozens of molecular formats in progress — and more arising all the time — the prospects for a platform process are few.
What companies need is an expanding toolkit of technical and scientific options to choose from, and suppliers of equipment, materials, and services are working hard to provide their own entries into that line-up. Top of the wishlist are methods for characterizing and monitoring product-related impurities such as malformed product variants and process-related impurities such as host-cell proteins. Although the latter can be addressed in ways familiar to many a monoclonal-antibody process, the former present a series of novel questions and concerns with every new bsAb format that arrives on the scene.
In this eBook, you’ll see how a number of groups are addressing these challenges and more as they develop a pipeline that is currently >600 programs strong.
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