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Using Quality by Design to Optimize Tech Transfer of a Blow-Fill-Seal Process

By Norman Weichbrodt and Mike Camalo, Catalent Pharma Solutions

Technology transfer is a difficult and sensitive process.  For a drug service supply partner, transferring an existing drug product from a customer’s facility to its own manufacturing plants offers an opportunity to increase value by improving process efficiencies and equipment design, and to incorporate operational excellence principles into the work.

Using the principles of pharmaceutical Quality by Design (QbD) can help set guidelines for tech transfer, and ensure that opportunities for process improvement are not overlooked when focusing on budget and deadline.

This article will summarize how Catalent worked within the QbD framework to help a customer transfer a new blow-fill-seal (BFS) process.

In 2010, Catalent was approached by a Fortune 500 drug manufacturer to transfer an existing ophthalmic product from a manufacturing site Catalent’s BFS facility in Woodstock, Illinois.  The product was already marketed commercially and the FDA approval for Catalent manufactured product was to be based on the manufacturing process used at the customer’s site.

Once the site was selected, the technical transfer process began with a detailed comparison of the client’s current manufacturing process vs. the process that Catalent had initially proposed..  A transfer document was created that retained the critical process parameters, while identifying areas of improvement.  In this project, opportunities were identified in the following processes:

  • Optimize the formulation from a three tank process to a two tank process
  • Incorporate an increased level of automation to the formulation process
  • Redesign of the unit dose BFS ampoule to minimize the probability of leakage
  • Redesign of the label and the label application process
  • Redesign of the foil pouch to reduce scrap experienced at the original site