News & Events > Press Releases
Kadimastem Launches Cleanrooms, Designed and Built According to GMP Standards
Mar. 29, 2015
Ness Ziona, Israel, March 29, 2015, Israeli biotechnology company Kadimastem (TASE: KDST) announces today the launching of cleanrooms it has built and certified in the last few months. The rooms will be used for the ongoing research and development of the company's medical solutions, and for the production of cells for clinical trials in the future.
The cleanrooms were built in compliance with Good Manufacturing Standards (GMP) and with the various authorities' regulations (EMA, FDA and the Israeli Ministry of Health). Complying with these regulations is required in the production of stem cell-based products and the use of Kadimastem's cell-based therapeutic products in clinical trials.
The cleanroom suite, certified by Gsap (specializing in advising stem cell and cell-based therapy companies), is adjacent to the research labs and the company's offices in the Ness Ziona Science Park. The cleanrooms enable the company the production of larger cell quantities by simultaneous production, which will be an advantage in later development phases. The decision to operate the cleanrooms derives from the intent to shorten development processes and control all stages up to the drug's approval.
Yossi Ben-Yossef, the company's CEO, noted "Kadimastem, as a company at the forefront of current medical technology, aspires to comply with the strictest standards, and to produce its products in a controlled environment while emphasizing safety and quality. The new cleanrooms are the foundation required for the next phases and the targets the company is aiming for, towards clinical trials in humans".
Kadimastem is a biotechnology company, operating in the field of regenerative medicine – a groundbreaking field in which the malfunctioning of organs which leads to diseases is repaired by external cells, tissues or organs. The company specializes in the development of human stem cell-based medical solutions for the treatment of diabetes and neurodegenerative diseases, such as ALS and Multiple Sclerosis. The company was founded in 2009 by Professor Michel Revel and Yossi Ben Yossef, and is traded in the Tel Aviv Stock Exchange (TASE: KDST). The company employs approximately 30 people, of which 11 are PhDs, in the Ness Ziona Science Park.
Kadimastem was founded based on patent protected technology that was developed at the Weizmann Institute of Science, in Prof. Michel Revel’s laboratory. Based on the company's platform, Kadimastem is developing two types of medical applications: A. Regenerative medicine for diabetes and ALS; B. Drug screening platforms which use functional human cells and tissues to discover new medicinal drugs. In this field, the company has two collaboration agreements with leading global pharmaceutical companies.
The company is headed by Yossi Ben-Yossef, an entrepreneur with vast experience in life sciences companies. Prof. Revel, who serves as the company's Chief Scientist and director, developed the blockbuster drug Rebif® for the treatment of MS ($2.5 billion sales in 2013). The company's chairman is Dr. Eli Opper, formerly the Chief Scientist of the Israeli Ministry of Industry, Labor and Trade.