Ortho Regenerative Technologies (CSE:ORTH) entered into an agreement with a leading contract manufacturing organization operating within the global biopharmaceutical industry to begin work on providing Ortho RTi with cGMP finished dosage form quantities of Ortho-R for currently planned clinical trials and strategic partnering initiatives.
“The initiation of this technology transfer from École Polytechnique to a well-regarded, cGMP-compliant manufacturing site marks an important step forward toward achieving our goal of taking this potentially game-changing technology into the clinic,” Ortho TRi executive chairman and CEO, Dr. Brent Norton, said in a statement.
In addition, the accord will allow the company to bypass the development risks associated with going into first-in-human studies by having scalable, cGMP materials. Ortho-R implants are in development for the biologic repair of tissue.
“As we move towards approvals by the FDA for our indications for use, and continue pursuing joint development initiatives with interested industry players, it should help give potential strategic partners confidence that they can rely on high quality, commercial production of Ortho-R,” Dr. Norton said.
