Telix has completed an agreement with contract development and manufacturing organization (CDMO) Grand River Aseptic Manufacturing (‘GRAM’) to perform commercial-scale Good Manufacturing Practice (GMP) manufacturing of Telix’s Illuccix product (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging.
Under the terms of the Agreement, GRAM will perform advanced aseptic fill and finish services for Illuccix at its facilities in Grand Rapids, (Michigan, U.S.A.) for the U.S., Canada, EU and Australian markets.
Telix Americas President Dr. Bernard Lambert stated, “With commercial distribution agreements in place with major radiopharmacy networks covering over 90% of the U.S. population, we are pleased to have entered this agreement with GRAM, thus delivering a key component of our manufacturing and supply chain strategy for GMP manufacturing of Telix’s first commercial product. As we prepare for the U.S. launch of Illuccix® it is especially reassuring to know that, subject to approval by the FDA, supply will originate from a site in Michigan, providing certainty of access for American men living with prostate cancer.”
GRAM President and CEO Tom Ross added “We wish to congratulate Telix on reaching this incredible milestone. It is a great honour to support pharmaceutical innovators with fill and finish services as they work to deliver novel drug products to market. GRAM’s partnership with Telix is founded on deep technical expertise and shared values that are backed by a strong quality record, world class equipment and passionate team members. I look forward to all we will accomplish together.”Back To Top
Telix, Grand River Aseptic Complete Agreement for Commercial Manufacturing of Illuccix. Appl Radiol.