![]() For this, Royce mentions the use of multiwell plates in the early lab-scale stages to screen potential media. There are many considerations researchers should keep in mind for downstream process workflow. Other systems include Eppendorf’s scalable BioFlo 320 benchtop bioprocess system and BioBLU® 3f Single-Use Fermentor and Sartorius Stedum’s widely used ambr® 15 and ambr® 250 bioreactors. GE’s ReadyToProcess WAVE™ 25 bioreactor and Xcellerex™ XDR-10 systems are such examples. These growth chambers replicate the conditions of their larger-scale counterparts while enabling scientists to monitor multiple cell lines and experiments at the same time. Here, scaled-down modeling tools such as benchtop bioreactors can help the scale-up process and make optimization less costly. He adds, “This extends beyond increasing the concentration of the protein to improving its quality, for instance trying to generate a cell clone that doesn’t produce a lot of aggregated or fragmented protein.” “With the upstream process, you’re trying to optimize the growth of the cells and the production of the protein,” explains Jonathan Royce, global product manager for antibody affinity media in GE Healthcare’s Life Sciences section. Upstream modelingĪfter drug-candidate selection, the design of the drug’s manufacturing-scale purification starts out at lab scale, in which both upstream and downstream processes come under scrutiny. ![]() Here we discuss what to consider as sample volumes increase, and what assistance is being offered by the companies that specialize in chromatography solutions to ensure your process design is as quick and efficient as possible. ![]() In theory, this is a simple procedure, as process parameters should be scalable in a linear fashion however, that is not to say the scale-up journey is guaranteed to be plain sailing. Its ubiquity can be attributed in part to the basic purification strategy, which, once determined at lab scale, remains largely constant throughout the scale-up process. Chromatography has become indispensable to the biopharmaceutical industry, transforming from a traditional analytical tool to one of the most enabling technologies for purifying small to large quantities of bioactive molecules. ![]()
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