Telix Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR), has selected Goodwin Biotechnology to optimize the process for cGMP manufacturing of its renal cancer imaging antibody drug conjugate TLX-250. The product will be used in Telix’s Phase III clinical study for the diagnostic imaging and staging of patients with clear cell renal cancer, and post-approval commercialization.

Goodwin Biotechnology is a U.S.-based, qualified and flexible full GMP contract development and manufacturing organization (CDMO) that offers a fully integrated single source solution from cell line development, process development, scale-up, cGMP contract manufacturing, and aseptic fill/finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and antibody drug conjugates (ADCs) for early- and late-stage clinical trials.

“The radiopharmaceutical landscape has historically suffered from a lack of effective late-stage product development,” said Christian Behrenbruch, chief executive officer, Telix. “Vendor selection is important to product development and as such we have selected Goodwin Biotechnology for manufacturing scale-up because of their track-record in antibody conjugation, including radiopharmaceuticals.”

“It was clear from the start that the Telix team is an experienced group of biopharma clinicians and executives, with a passion for radiation biology and oncology'” said Karl Pinto, chief executive officer, Goodwin Biotechnology. “We share their belief that the time for this technology has arrived and we are impressed by the pipeline development strategy.”

Muctarr Sesay, chief scientific officer and vice president of bioconjugation, Goodwin Biotechnology, said, “Goodwin’s experience with radioimmunoconjugates makes us an excellent partner to move forward with Telix’s lead program in renal cancer. We’re confident that we can optimize a robust process and scale it up to cost-effectively supply sufficient amounts of the Girentuximab Conjugate for radiolabeling in order to meet the demand for the confirmatory Phase III trial and beyond.”