Q&A

Analytical Method Development In A High Potent Facility

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In this interview with Amanda Blackwell, Head of Analytical Development at PCI Pharma Services, review the importance of analytical method development in pharmaceutical outsourcing and why a thorough understanding of development objectives and the gathering of relevant data is critical.

Understanding the capabilities that a Contract Development and Manufacturing Organization (CDMO) should offer for analytical method development and the benefits of outsourcing these services to a CDMO can help improve efficiency and ensure your project advances through development seamlessly. Selecting a CDMO partner that can handle most of the method development and validation activities, while outsourcing specialized aspects to an approved third-party, can be advantageous. By having the CDMO partner oversee all aspects of analytical method development and conducting the majority of the work in-house, clients can benefit from a more comprehensive service that is crucial for achieving speed in clinical trials, regulatory approval, and commercial launch.

Blackwell also mentions the potential benefits of using a single partner for outsourcing analytical method development, depending on the project requirements. Gain valuable insights for pharmaceutical companies seeking to outsource analytical method development and ensure successful drug development.

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