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CPDC Enters Clinical Manufacturing Deal with CellBion

CDMO expands into Asia with a development, manufacturing and clinical supply agreement for 177Lu-PSMA (DGUL).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The Center for Probe Development and Commercialization (CPDC) has entered a development, manufacturing and supply agreement with CellBion for Lu-177-radiolabelled PSMA (DGUL) therapeutic agent. CPDC will develop and manufacture CellBion’s drug product for Phase II clinical supply in South Korea with the goal of expanding into North America.

CPDC is a contract development and manufacturing organization (CDMO) for the GMP manufacturing and global distribution of radiotherapeutics.

“We are very excited to be working with CellBion,” said Bruno Paquin, CEO of CPDC. “CPDC has an excellent track record at manufacturing and supplying radiopharmaceuticals for multiple international clients. Expanding our portfolio in Asia is a significant milestone as we thrive to support our partners from early clinical development to commercial manufacturing.”

Based in Seoul, South Korea, CellBion is developing a novel PSMA-targeted radiotherapeutic for the treatment of prostate cancer. Lu-177-PSMA (DGUL) is currently in Phase II clinical trials in South Korea and has shown relatively high blood-to-cancer accumulation rate and a low kidney-uptake rate compared to competing drugs.

CPDC offers the in-house production of n.c.a. Lu-177—in partnership with Isotopia Molecular Imaging—in addition to its manufacturing, analytical, regulatory and quality expertise,  to enable uninterrupted and reliable supply of CellBion’s drug product globally.

“We are delighted to be working with CPDC and to offer our product, Lu-177-PSMA (DGUL), to the North American market” said Kweon Kim, CEO of CellBion. “We are impressed with the caliber of work and the professionalism provided by the entire CPDC team and very much look forward to the successful delivery of our program in order to provide clinical supply of our lead product in South Korea and extend it to North America.”

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