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Manufacture Facilities, Packaging

Fill & Finish of the Future

When it comes to the final stage of packaging before a product is injected into the patient, it’s understandable that the regulators expect perfection, both in process and the related documentation. This is the last line of defense. Over the past five years, there have been a significant number of quality and compliance issues identified by the FDA, particularly in documentation and quality control. The ‘checks and balances’ that prove sterility are fallible. Indeed, every vial can’t be checked for sterility, so it’s vital to have several layers of accumulated data to be confident that the product is safe. If there are chinks in the armor of quality systems – even if the sterility testing identified no issues – the FDA will not feel confident in the product.

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About the Author

Susan Dexter

When Susan started her career in biotechnology, the industry was in its infancy, but working in contract manufacturing has allowed her to see all the new technologies that have supported the rapid growth of clinical and commercial manufacturing of biologics. “As Chief Business Officer at Xcellerex, working on the disruptive platform of fully integrated single-use facilities and closed system manufacturing was a real boon. Since then, being involved in the evaluation and implementation of disruptive fill-finish technologies is the icing on the cake,” says Susan.

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