China based Gracell Biotechnologies Inc., a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, has announced that the company has entered into a Manufacturing Service Agreement (MSA) with Lonza for clinical manufacturing of Gracell's FasTCAR-enabled CAR-T cell product candidates in the U.S.
Gracell is advancing its innovative CAR-T pipeline globally for difficult-to-treat cancers, including its lead program for GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma.
This autologous CAR-T product candidate is manufactured on Gracell's proprietary FasTCAR technology platform, which significantly reduces the manufacturing time from an industry norm of two to six weeks down to next day.
Gracell will leverage Lonza's integrated services in CAR-T manufacturing and establish state of the art cGMP process, a critical component of Gracell's IND enabling clinical development programs.
"Gracell has developed some highly innovative CAR-T manufacturing platforms, including our FasTCAR platform enabling next day manufacturing of autologous CAR-T products. With Lonza's experience in CAR-T therapy manufacturing and excellent reputation, they are an ideal strategic collaborator for advancing our pioneering, proprietary FasTCAR platform globally," stated Dr. William Wei Cao, Chief Executive Officer of Gracell.
Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, added, "We are pleased to enter into this collaboration with Lonza and are currently building our international presence, including clinical operations to advance our product candidates and bring them to more patients globally. We look forward to a strategic relationship with Lonza to support IND-filing and clinical manufacturing in the U.S."