![]() ![]() ![]() Clearly, more analytics are needed, performed online or at-line, in an automated or semi-automated fashion through a unified platform. Manufacturing practice is trending toward more analytics through multiple offline instruments, but that level of sophistication and automation will not support current quality and process understanding initiatives. That scenario would be unthinkable in the semiconductor industry, but that is how most bioprocess analytics are carried out. Imagine a three-week manufacturing process during which only essential process conditions were analyzed, but only intermittently and offline, in a separate laboratory. Consequently, the FDA has felt pressure to become an agent for moving biotech into the 21st century by encouraging monitoring and testing to demonstrate that the process is in control. “In biotech, regulatory agencies are still struggling with understanding what it means to control a process with product quality as the goal.”īioprocessors know the product they want, but are often restricted by limitations of available analytic tools. According to Bob Fox, biotechnology corporate accounts manager at Nova Biomedical (the difference between traditional small molecule pharmaceuticals and biologics is that the former are well characterized, both for molecule and process, and therefore relatively well controlled. Increasingly, bioprocessors are adopting all-in-one instruments that analyze multiple parameters and produce readouts at assigned time points. How well control over these parameters affects the final product depends on the manufacturer’s commitment to process development and understanding. A myriad of parameters are potentially critical: temperature, agitation rate, cell density, and viability, plus concentrations of nutrients, gases, and waste products. Understanding which analytes matter most within a cell culture or fermentation process takes considerable upfront development work. Trend is Toward All-in-One Instrumentationīioprocess monitoring is rapidly becoming a tool for achieving process understanding and control and, ultimately, for realizing high yields and quality product. ![]()
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February 2023
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