Just days apart, the company was hit with a Complete Response Letter and a clinical hold related to the FDA’s inspection findings at a third-party manufacturing facility.
The integrated CDMO is aiming to enhance manufacturing efficiencies for KaloCyte’s lead candidate, ErythroMer, a bioengineered artificial red blood cell substitute.
The cell therapy CDMO will provide technology transfer, analytical method transfer, and cGMP manufacturing to support Secretome Therapeutics’ lead asset STM-01.
