CASE STUDY: Pre-Launch Manufacturing Issues


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A client experience an issue with the failure of stability studies due to an extractable from the container.


BioPhia Role:

A team was assembled with experience in Biocompatibility, Analytical Chemistry, and Extractable / Leachable product testing.



The BioPhia team reviewed the results, brainstormed resolutions, and developed a test plan to fix the issue.



In 2 weeks an action plan was developed in conjunction with the client that got the product development back on track.