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Chromatographic processes are used to obtain the purity required for biotechnology products. To avoid excessive costs, validation planning is optimally begun during process development. Designing validation into the Chromatographic process requires training researchers in the importance of validation. Once the process is defined, it can be successfully scaled up to prepare clinical trial material. SOPs must be written for buffer preparation, operation and maintenance of the columns and systems, storage, cleaning, and criteria for acceptability of a column for initial use and lifetime determination. If research has defined the key elements, these SOPs can be written and implemented without further excessive experimentation that leads to regulatory delays.
chromatography, validation, research, design, cleaning, biopharmaceuticals, diagnostics
Pharmacia Biotech, Piscataway, NJ