Cell Culture Process Analytical Development
Cell culture process development activities at KBI cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies.
The KBI team has worked with protein production processes at all scales, from laboratory, pilot, and clinical scales to commercial scales up to 2000L. We have characterized mixing conditions in bioreactors from ambr15 to 2000L scale. An in-depth understanding of the impact of agitation, aeration, and working volume at each scale has allowed us to successfully tech transfer in a wide variety of processes.
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