Pluristem's Manufacturing Facility Approved by European Auditors for Phase III Trials
HAIFA, Israel, April 28, 2014 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR) today announced that its new manufacturing facility has received the European Union's Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III.
The Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem's new facility, equipment, utilities, and quality management systems. Pluristem's manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
"This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials," stated Zami Aberman, Chairman and CEO of Pluristem. "We believe Pluristem's advanced, commercial scale cell manufacturing facility is one of our Company's key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward."
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem's manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany's health authority.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
Видео Pluristem's Manufacturing Facility Approved by European Auditors for Phase III Trials канала CorporateProfile
The Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem's new facility, equipment, utilities, and quality management systems. Pluristem's manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
"This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials," stated Zami Aberman, Chairman and CEO of Pluristem. "We believe Pluristem's advanced, commercial scale cell manufacturing facility is one of our Company's key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward."
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem's facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem's manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany's health authority.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
Видео Pluristem's Manufacturing Facility Approved by European Auditors for Phase III Trials канала CorporateProfile
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
![U.S. Navy Approves Start of CEL-SCI's Phase I Trial for HIV/HPV Co-Infected Patients](https://i.ytimg.com/vi/TYtOBXrFKBE/default.jpg)
![CPreports 12/3/12 - Greece Debt Buyback, Delta wants Virgin, Vampire in Serbia on the Loose](https://i.ytimg.com/vi/JdFGtfJg3vU/default.jpg)
![CorporateProfile.com interviews Nic Toms, Decision Point Systems (DNPI)](https://i.ytimg.com/vi/w3wQR3PDREs/default.jpg)
![White House Sexual Misconduct Scandal, China Astronauts, NYC Diabetes Epidemic](https://i.ytimg.com/vi/8tOe5krQ04A/default.jpg)
![News 2/19/13 - Magnolia Bakery Mice Infestation, Maker's Mark Scandal, Burgerking's Twitter Hacked](https://i.ytimg.com/vi/iyaN5qRCe1M/default.jpg)
![Interview w/ West Australian Distilling Company Co-Founder Andy Nye](https://i.ytimg.com/vi/xx7pNoz1JTc/default.jpg)
![Kitov Reports KIT-302 Has Beneficial Effects on Kidney Function](https://i.ytimg.com/vi/M3SAjYL5Q9I/default.jpg)
![Daby Carreras, of Spartan Capital Securities, speaks about The Wall Street Run and Heart Walk](https://i.ytimg.com/vi/y4B03MJGn8o/default.jpg)
![Corporate Profile interviews Celebrity Photographer Michael Letterlough Jr.](https://i.ytimg.com/vi/CeZLddeC0L8/default.jpg)
![Deadlock in Pope Election, Cyberterrorists Attack US, Cannibal Cop Life in Prison - News 3/13/13](https://i.ytimg.com/vi/CmtrkK-TyEE/default.jpg)
![Corporate Profile talks to CEO of Pluristem about its New Product for Acute Radiation](https://i.ytimg.com/vi/XZOut6accnA/default.jpg)
![Bluesphere Announces Start of 5.2 MW Waste-to-Energy Project in Charlotte, North Carolina](https://i.ytimg.com/vi/ShTbzKCDlFY/default.jpg)
![Cory Monteith Overdose, North Korea Ships Missiles in Sugar, & Woman Struck by Lightning in Store](https://i.ytimg.com/vi/jkvMFLOmlrs/default.jpg)
![University of Minnesota Masonic Cancer Center Joins CEL-SCI’s Phase III Head & Neck Cancer Trial](https://i.ytimg.com/vi/kVTAD60QZr8/default.jpg)
![Wize Pharma Hopes To Shake Up $3.7B RX Eye Drop Market](https://i.ytimg.com/vi/YBw3cO_YMsM/default.jpg)
![SmartMetric to Launch World's First Bitcoin Card With Biometric Fingerprint Protection](https://i.ytimg.com/vi/Qgzc9joma7Q/default.jpg)
![First Bitcoins Seized by Feds, Cuba backs Snowden Asylum, Andy Murray makes Wimbledon 2013 History](https://i.ytimg.com/vi/sFYbz_kMR-s/default.jpg)
![CEL-SCI Receives Approval to Expand Its Immunotherapy Phase III Cancer Trial into the UK](https://i.ytimg.com/vi/W0RNmEE6jw0/default.jpg)
![Can-Fite Issued Japanese Patent for Treatment of Liver Regeneration](https://i.ytimg.com/vi/4gnxFB99Vgg/default.jpg)
![LabStyle Innov. Successful User Performance Evaluation Study to Support 510(k) Application](https://i.ytimg.com/vi/U-CKbCumGHA/default.jpg)