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Pre-Launch Manufacturing

The client was faced with looming setbacks of the product development timeline due to a failure of stability studies stemming from the product’s container. A team of BioPhia experts in biocompatability, analytical chemistry, and extractable and leachable testing were assembled to develop a plan to quickly get the product development back on track.

Pre-Launch Manufacturing


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.

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