- Polyrizon has produced a Good Manufacturing Practice (GMP) batch of clinical trial material for its lead intranasal product candidate.
- The batch was manufactured with Eurofins CDMO AmatsiAquitaine and will support a planned clinical study in the United States later this year.
Polyrizon announced the successful production of a Good Manufacturing Practice (GMP) batch of clinical trial material (CTM) for its lead product candidate. The company is a pre-clinical-stage biotechnology firm developing intranasal administered solutions.
The GMP batch was manufactured in collaboration with Eurofins CDMO AmatsiAquitaine S.A.S, a CDMO providing contract manufacturing services. The production follows a previously announced manufacturing agreement between the companies to support Polyrizon’s clinical development program.
The milestone supports Polyrizon’s preparations for a planned clinical study in the United States later this year. According to the company, the clinical trial material batch will be used for upcoming clinical activities and regulatory submissions related to the study.
The GMP batch production follows the successful manufacture of two development batches that demonstrated batch-to-batch consistency and product stability over time. These earlier batches supported the reproducibility and robustness of the manufacturing process used to produce the clinical material.
“This manufacturing milestone represents an important step in advancing our clinical development strategy. Following the successful production of development batches that confirmed manufacturing consistency and stability, the GMP production of clinical material enables us to move forward with our planned U.S. clinical study and reflects our continued commitment to developing innovative intranasal solutions designed to protect against airborne allergens and viruses.”
Tomer Izraeli, CEO of Polyrizon
