Application of an Effective In-Line Analytical Instrument for Biopharmaceutical Development and Manufacture

The rapid advancement and competitive
environment of the modern biopharmaceutical industry, accompanied by the need for continuous quality improvement, demand robust analytical instruments. Analytical technology is one key factor contributing to the quality and safety of finished products. Ongoing improvements in analytical instruments are needed to address new challenges, including specificity of target substances, high complexity of matrices, and multiple production stages with a number of input and output parameters and peculiarities. Those factors point to the demand for a versatile solution, one that can be used accurately and reliably for analyses of intermediate and end products in a number of bioprocesses.

Ultraviolet-visible (UV-vis) instruments constitute a large portion of the analytical tool set
currently used in the biopharmaceutical industry, although most traditional UV-vis technologies have a narrow detection range that can limit functionality in direct applications. Because the light absorbance value in UV-vis is directly proportionate to pathlength of the light and sample concentration (according to the Beer–Lambert law),
the fixed-pathlength principle of conventional UV-vis analytical techniques is a key obstacle to expanding the concentration range of an instrument. That calls into question the feasibility of in-line applications of UV-vis instruments. Even off-line measurements with such devices can be problematic because of manual and human error. In this regard, significant benefits can come from an instrument that is capable of high-speed continuous
data collection, broad concentration-range measurement, and in-line application. The CTech FlowVPX instrument is an in-line system that fulfills all of the above demands as an analytical tool in the biopharmaceutical industry.

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