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Cder guidance validating chromatographic methods

Implementing continuous process improvements is increasing in priority for the biopharmaceutical industry.

Examples include growth medium optimization, purification column operation optimization, and enhanced recovery during final filling (2).

Continuous improvement and innovation projects often call for changes to licensed processes that require validation, but not necessarily animal or clinical studies.

PRODUCT FOCUS: RECOMBINANT PROTEINS PROCESS FOCUS: PRODUCTION WHO SHOULD READ: PROCESS DEVELOPMENT, ANALYTICAL, REGULATORY AFFAIRS, AND MANUFACTURING KEYWORDS: PROCESS OPTIMIZATION, CELL CULTURE, SCALE-UP/SCALE-DOWN, MODEL SYSTEMS, PRODUCT QUALITY/COMPARABILITY LEVEL: ADVANCED Validation of cell culture process changes has been performed traditionally at scale, in a manufacturing setting, through the whole length of a campaign.

However, it is infeasible for many companies to devote a full-scale production unit to a validation study because of potential impacts on production capacity output and/or supply risk, cost burden, manufacturing resource availability, and logistics complications (e.g., the need to segregate validation from commercial materials).

Moreover, when a production unit is devoted to a validation study for a proposed process change, the resulting drug product manufactured often must not be released but rather kept on hold until stability and all predetermined acceptance criteria have been met and verified.

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Putting product release at risk has multiple implications, including patient supply, operational, logistical, and financial consequences.

All those can prohibit validation and lead to lost opportunities for potentially important production process improvements.

Such problems affect many companies in the biopharmaceutical industry regardless of the scale of their production bioreactors (ranging from ~20 L to >20,000 L), modes of production (lasting from days, as in fed-batch mode, to months in the case of perfusion bioreactors), and the number of units available for manufacturing.

Given those constraints, establishing qualified scale-down platforms that need not comply with good manufacturing practices (GMPs) would facilitate continuous life-cycle process improvements (3).

Validation of process changes thus could be performed without taking a production unit off line.

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