Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies
Challenges remain, however, in designing a complete, streamlined, single-use process for downstream protein purification. In-process sensor technologies, chromatography, and temperature control are all areas that have been traditionally underserved by single-use technologies and represent “weak points” in the downstream process flow. Exacerbating the problem, most proteins are heat labile and sensitive to a large number of environmental conditions. Therefore, interruptions in the process and improper temperature management can increase aggregation (which can lead to unstable formulations) or even degradation and denaturation in worst cases.
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