The objectives the biotech industry have evolved since its origins. Consequently, ways of working need to be revised as they lead to suboptimal operations from the future market demand perspective. As the biotech industry matures concepts such as process intensification and/or PAT will lead to more efficient manufacturing practices that will meet future market needs.<br/>One of the industry trends, focusing on process intensifications that have been presented in recent years is related to in-line dilution of buffers where the focus has been reducing the floor space needed for buffer storage and enabling the use of bags for holding of the buffer concentrates. Another, even more powerful technique, is In-line Conditioning (IC) where not only the floor space issue is addressed but also the complexity and inherent variability in buffer preparation.<br/>This presentation will provide a general overview of the IC technology, and discuss validation strategies and economical setups for IC, and similar, traditional operations technologies. Examples of successful In-Line Conditioning of buffers in an albumin process will be given. The final buffer properties fall within the required specifications for pH and conductivity, even in the case of variability of stock solutions.

Overcoming buffer challenges in downstream processes by In-line conditioning

251st National Meeting (2016)

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