Immunovative Therapies, Ltd. (ITL) has completed upgrades to its GMP cell manufacturing facility and GMP operations in Jerusalem to comply with the requirements of advanced clinical trials. The completion and validation of its manufacturing facility will allow the company to launch a Phase II/III trial as planned early in 2013.
The facility upgrades include: two class 10,000 cleanroom facilities, interlocked rooms with increasing levels of pressure and air quality, separate rooms for personnel flow and materials flow, clean space for inventory and finished product storage, and product packaging and shipping. ITL has also completed the Installation Qualification (IQ) validation process for the upgraded facility and the Operation Qualification (OQ) and Performance Qualification (PQ). Once PQ is passed, an initial three trial production run will be conducted. If successful, the facility will be brought on-line in April 2013.
Dr. Michael Har-Noy, founder and chief executive officer of ITL, said, “We are very pleased with the progress for developing new manufacturing technology solutions and the rapid and cost-effect manner in which these technologies are being transferred to the manufacturing floor. We are also pleased that we have been successful in developing technology enabling the economical distribution of our formulated cell products. The investments in R&D and these new GMP manufacturing facilities are consistent with our strategic plan to become the world's leading authority for the mass production and distribution of living cell products."