Liaison(s): Richard Aman, Craig Johnson
Gilead Sciences is an American biopharmaceutical company founded in 1987. Today, Gilead has offices in 35 countries, approximately 11,000 employees and $24B in revenue. Gilead’s commitment to advancing the treatment of viral and inflammatory diseases and cancer has led to the development of dozens of life-saving therapeutics. The active ingredient of AmBisome®, Amphotericin B, was first licensed in 1959 and has been in use for over 60 years as antifungal medication for serious fungal infections. Approved in 1997, AmBisome® is a liposome encapsulation manufactured at Gilead in La Verne, CA. One step in the manufacturing process entails lyophilization of liquid product, and our team is developing methods to monitor equipment performance during this critical step using data visualization and analysis. Specifically, we are evaluating selected tags for their association to successful product batches. A tag refers to an equipment measuring unit such as pressure or temperature. We use software such as Batchview and Microsoft Excel to analyze tag data from historical production runs and identify trends that indicate ideal or non-ideal equipment parameters. Our deliverable will entail a reporting tool to alert Gilead personnel when production line equipment parameters begin trending outside specific limits with the goal that the deviation can be remedied before the production batch is negatively impacted. Additionally, our tool will provide a means to visualize and analyze tag data after the lyophilization step is complete.
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