Advanced therapy developers and manufacturers have gravitated to closed systems to reduce contamination risk during manufacturing and streamline their workflow. GeminiBio’s clinical grade products are now available in our Aseptic Assurance System™ cryo-bags to improve customer’s aseptic processes and reduce risk.

GemCell^TM Plus Xeno Free, World Grade – designed to meet specific regulatory requirements, including requirements within the United States and the European Union. Source plasma is collected from a maximum of 16 healthy male donors of the AB serotype and passes extensive viral testing requirements. 

GeminiBio’s range of formulation tank sizes allow us to support cell therapy customers as they scale their production.  We offer custom cGMP liquid manufacturing in batch sizes from 10-liters to 10,000-liters, and can customize fill size and container type based on each customer’s needs. GeminiBio’s TrueCustom^SM and ExpressCustom^SM service models provide Cell Therapy companies and CDMOs with a truly market differentiated service level.

For the cell culture of CAR-T and other cells where stringent regulatory requirements must be met, GeminiBio offers GemCell^TM Plus Xeno Free human AB serum.  GemCell^TM Plus Xeno-Free Human Serum is collected from healthy male donors of the AB serotype at FDA-licensed facilities in the United States. Manufactured under cGMP, this material goes through rigorous testing and contains therapeutic-grade human thrombin to support the increasingly stringent regulatory requirements of advanced therapies.

For culturing of T Cells for oncology applications, GeminiBio offers Yssel’s T-Cell Media.  Yssel’s T-Cell Media allows for the proliferation of primary T Cells and can be used alone or as a basal media. Manufactured under cGMP conductions, Yssel’s T-Cell media is available in a xeno free and phenol red free formulation, and custom manufacturing and packaging options are available.

GeminiBio’s ultrapure water is available in USP or multicompendial USP/EP/JP Grades for Water For Injection (WFI) Quality Water packed in bulk for commercial use.  Our WFI quality water meets the needs of upstream and downstream bioprocessing and manufacturing applications and complies with the Untied States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP) as indicated.  Packaged in bulk for commercial use and custom manufacturing options available.