Navigation Links
Stemedica Achieves Major Milestone - Company Receives License to Manufacture Clinical Grade Stem Cells
Date:9/1/2009

Stemedica Cell Technologies, Inc., ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today that it has been granted a license by the State of California's Food & Drug Branch to manufacture stem cells for human clinical trials. This Drug Manufacturing License recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

San Diego, CA (PRWEB) Sep 1, 2009 -- Stemedica Cell Technologies, Inc., ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today that it has been granted a license by the State of California's Food & Drug Branch to manufacture stem cells for human clinical trials. This Drug Manufacturing License recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

"This is an important development for Stemedica." said Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica. "With this license we become an even stronger worldwide leader within the stem cell industry. Our stem cells and stem cell-derived factors can now be purchased by pharmaceutical and biotech companies, research institutions and medical facilities conducting approved human clinical trials. As more and more organizations get involved with stem cell research and clinical trials, including drug discovery programs, Stemedica's ability to service their needs becomes a critical asset to the organization and to the industry."

"This stamp of approval positions Stemedica as one of only a few companies in the world capable of manufacturing and delivering its own unique multiple cell products and factors. The Company also has the ability to custom manufacture for select companies. These dynamic capabilities give us a significant point of advantage in the marketplace." said Roger Howe, PhD, Executive Chairman for Stemedica.

Stemedica has dedicated significant financial and human resources over the past four years in preparation for securing this license. The government's rigorous inspection and approval process has included: a comprehensive, in-depth audit of Stemedica's manufacturing process and procedures; examination of Stemedica's Quality Systems; interviews with facility management; and an onsite inspection of the facility.

"We're very proud of the hard work, dedication and professionalism of the team that has made this possible." stated Maynard Howe, PhD, Stemedica's Vice Chairman and Chief Executive Officer. "Their experience and expertise has been instrumental in assuring that our facility meets regulatory compliance requirements. With the approval and licensing process behind us we can now focus our efforts on manufacturing the highest quality stem cell products."

About Stemedica Cell Technologies
Stemedica Cell Technologies, Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company has currently filed a pre-IND request with the FDA in preparation of IND submissions for stroke and wound repair. Stemedica is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com

Read the full story at http://www.prweb.com/releases/Stemedica-cGMP-stem-cell/manufacturing-license/prweb2817054.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related biology technology :

1. Stemedica Selected By World Stem Cell Summit To Present Scientific Discoveries
2. Stemedica Requests Pre-IND Meeting With FDA
3. Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher
4. Renowned Stem Cell Researcher Files Study Results With Stemedica
5. CIRM Completes Briefing Visit to Stemedica Cell Technologies
6. Stemedica Announces the Appointment of Dr. Michael Bayer as Director, Medical Services
7. BioNeutrals Ygiene(TM) Hospital Grade Achieves a 100% Total Kill (Pass) Against the Life Threatening Clostridium Difficile (C.diff) Spores in Independent EPA Required Protocol Testing.
8. BioNeutrals Ygiene(TM) Hospital Grade Achieves World Class Independent Test Results in Killing Life Threatening Spores/Organisms
9. Environmental Tectonics Corporations BioMedical Division Achieves Foreign Manufacturer Accreditation in Japan
10. Healthy Advice Networks Achieves Strong Growth Despite Challenging Economy
11. Pepscan Achieves a Breakthrough With CLIPS Immunogen Technology: Synthetic Peptide Antigen is Able to Induce Fully Functional Antibodies Against a Formerly Intractable GPCR Target CXCR7
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Stemedica Achieves Major Milestone - Company Receives License to Manufacture Clinical Grade Stem Cells 
(Date:12/9/2016)... , December 9, 2016 According to a ... (Primer, Probe, Custom, Predesigned, Reagent Equipment), Application (Research, PCR, Gene, DNA, ... 2021" published by MarketsandMarkets, the global market is expected to reach ... at a CAGR of 10.6% during the forecast period. ... ...
(Date:12/8/2016)... LONDON , Dec. 8, 2016 This report ... following Product Segments: Acid Based (Humic, Amino, & Fulvic), Extract ... by the following Crop Types: Ornamental & Turf, Row Crops, ... US, Canada , Japan ... , Latin America , and Rest of ...
(Date:12/8/2016)... Dec. 8, 2016  OncoSec Medical Incorporated ("OncoSec") ... DNA-based intratumoral cancer immunotherapies, today announced financial results ... "We are delivering on our commitment to ... ImmunoPulse┬« IL-12. We are pleased with the early ... trial, and we are focused on advancing our ...
(Date:12/8/2016)... India , December 8, 2016 ... a comprehensive analysis, titled Global Amyloglucosidase Industry 2016 Market Research ... classification, application, and industry chain overview are all covered in ... SWOT analysis, and investment return analysis of the Amyloglucosidase industry. ... , , ...
Breaking Biology Technology:
(Date:11/22/2016)... , Nov. 22, 2016   MedNet Solutions , ... entire spectrum of clinical research, is pleased to announce ... LiveWire Healthcare and Life Sciences Awards as "Most ... off an unprecedented year of recognition and growth for ... over 15 years. iMedNet ™ ...
(Date:11/16/2016)... 2016 Sensory Inc ., a ... for consumer electronics, and VeriTran , a ... industry, today announced a global partnership that will ... authenticate users of mobile banking and mobile payments ... software which requires no specialized biometric scanners, yet ...
(Date:6/27/2016)... DUBLIN , June 27, 2016 Research ... in North America 2016-2020" report to their offering. ... North America to grow at a CAGR ... has been prepared based on an in-depth market analysis with inputs ... growth prospects over the coming years. The report also includes a ...
Breaking Biology News(10 mins):