Journal of pharmaceutical sciencesVitamin B 12AntibodiesMonoclonalAnimalsBiotechnology
Discoloration source and control of a biotechnological drug product manufactured using a high titer production process.
Jian Liu, Zhongqi Zhang, Alla Polozova, Becky Chan, Nimesh Savjani, Jette Wypych, Yi Yu Rice, Pavel V Bondarenko, David J Semin, Yasser Nashed-Samuel
Published: 202610.1016/j.xphs.2025.104045
Abstract
Control of product quality attributes is central to the development of a safe and efficacious therapeutic protein product. The product color, as a potential critical quality attribute, can be a good indicator of protein structural integrity, quality…
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