The Product Development Laboratory is responsible for supporting investigators as they apply for INDs and move their investigations toward a cGMP process to support Phase I/II clinical trials.
In one instance, an IND application was delayed for 13 months due to questions and concerns the FDA had regarding the use human AB serum, which contained bovine-derived components and had insufficient testing at the donor-level.
To address these concerns, the investigator had to implement changes to the investigation that resulted in months of rework and included requalifying and testing a new supplier.
GeminiBio collaborated with the Product Development Lab to understand their needs and provided human AB serum that was xeno-free and extensively tested, which met the concerns posed by the FDA, while supporting the cell culture performance requirements of their investigation.
In addition, GeminiBio collaborated with the Product Development Lab to become a preferred supplier for the labs they support within the Cellular Engineering Department, offering multiple grades that met the needs of the investigations at each stage of their research and development. All of GeminiBio’s human AB serum is manufactured under the same quality system in the company’s ISO 13485 and 21 CFR 820 compliant facility, which eliminated the need to requalify new suppliers.
GeminiBio was able to help the Product Development Lab streamline IND applications and reduce concerns from the FDA.