Lonza has extensive experience with regulatory agencies in both the United States and Europe and have validated a large number of processes. The scope of the studies performed is dependent on our customers’ needs based on the regulatory guidelines. Typically, the studies performed would include a genetic characterization of the cell line, various process limit evaluations, a range of raw material expiry experiments and a fermentation consistency series. As some of this information can be collected during a typical cell culture program, an early meeting with the regulatory authority and thus timely consideration of the regulatory package is recommended.
In addition, our experience includes validating purification processes for acceptable critical process parameter operating ranges, for the reuse of purification components, and for the ability of the process to remove process related impurities, DNA and viruses. |
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