Company had used GeminiBio human AB serum for a number of years, but as their project progressed through the development process there was concern regarding the evolving regulatory environment.
To reduce risk and potential concerns from the US FDA, the customer decided to transition to GeminiBio’s human serum product that was free of bovine components and more extensively tested. However, the product needed to exhibit similar performance as the current human serum the company was using in their workflow.
GeminiBio collaborated with the company to provide GemCellTM Plus Xeno-Free samples for the company’s testing and review. GeminiBio’s GemCellTM Plus Xeno Free is free of bovine derived components and has more viral testing than the human serum product the company was using.
GemCell Plus Xeno-Free Human Serum performed in line with their requirements and allowed the company to be positioned for the future IND process by reducing risk and the ability to address requirements from the US FDA.