IMMUNOVATIVE PASSES INDEPENDENT GMP AUDIT

Immunovative announces successfully passing baseline audit from independent auditors of its GMP manufacturing facility in Jerusalem.  The manufacturing facilities in Jerusalem were inspected for compliance with current good manufacturing practices (cGMP) pursuant to 21 CFR, CGMPs provide for systems that assure proper design, monitoring, and control of biopharmaceutical manufacturing processes and facilities.

Adherence to the CGMP regulations assures the identity, function, safety and quality of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls is designed to prevent instances of contamination, mix-ups, deviations, failures, and errors.  The Company puts a high priority on safety of its products. The passing of this important milestone provides evidence that our drug products meet quality standards so they can be used in advanced clinical trials.

SPECIALITY INFORMATION

patients


Treatment strategy designed to use the power of the human immune system to kill tumors and prevent their recurrence.
No requirement for a matched donor or chemotherapy/radiation conditioning prior to treatment.
Innovative technology – proven and non-toxic.
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Healthcare professionals


Therapeutic anti-tumor vaccine developed from core break-through technology called the "Mirror Effect™“ which opens a pathway to treating patients with metastatic cancer that have failed all available therapy options.
Elicits a GVT-like mechanism without the GVHD toxicity.
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Investors


Privately-held Israeli biopharmaceutical company spin out from Hadassah-Hebrew University Medical Center with headquarters in Jerusalem.

Over 200 individual private shareholders and grant support from the Israel Office of the Chief Scientist.
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