Cryo-Save becomes the first stem cell banking company in India to receive the WHO – GMP certification
October 17, 2011 – Bangalore, India: In a country where lack of stringent regulations has been causing the general public to view stem cell banking with a certain degree of trepidation, there is reason to cheer. Cryo-Save India, subsidiary of the leading Europe-based family stem cell banking company, has become the first to receive World Health Organisation – Good Manufacturing Procedures (WHO-GMP) certification.
WHO-GMP certification guarantees superior quality, safety and effectiveness of production. In the case of blood products like stem cells, WHO-GMP guidelines govern every aspect of production and testing which includes construction, design and maintenance of the premises, qualification of equipment, extraction process, laboratory conditions, component preparation and validation and cross contamination, mix-ups and labelling, that can impact the quality of the product.
Stem cell banking in India is still in its nascent stages with no strict regulations governing the industry like in the west. Organizations like Cryo-Save voluntarily opting for accreditations and certifications help in elevating the credibility of the industry in a market rift with scepticism and lack of knowledge on the merits of an evolving technology.
Commenting on the certification, Arnoud van Tulder, CEO, Cryo-Save Group said, “As a Group, we are thrilled to receive the WHO-GMP certification in India. In the absence of a guidance mechanism, new parents are constantly battling questions on quality and methods employed by stem cell banks in India. I am certain that the certification will serve the cause of boosting the confidence levels in the stem cell industry and our company in particular. ”
Marc Waeterschoot, QP and Co-founder, Cryo-Save Group said, “Given that the concept of stem cell banking and therapy is relatively new in India, we are happy to have proactively obtained WHO-GMP certification since quality and dependability of stem cell banks is a huge concern in emerging markets.”
Rajesh Sharma, Managing Director, Cryo-Save India, said, “While we can talk of how important it is to have stricter regulations in the industry, it is important to demonstrate superior capabilities that can match the best in the world, even where there is no binding regulation driving it. By obtaining the WHO-GMP certification, we believe we have demonstrated just that.”
About Cryo- Save:
Cryo-Save India, a 100% subsidiary of Cryo Save Group N.V which is Europe’s largest adult stem cell storage bank, is headquartered in Bangalore with a state-of-the art fully automated adult stem-cell storage facility.
Cryo-Save Group N.V. (Euronext: CRYO) is Europe’s largest adult stem cell storage bank, with more than 170,000 samples stored. The Company was established in 2000, headquartered in The Netherlands, and owns or has access to, operating laboratory and storage facilities in Belgium, Germany, Dubai, India and France (in progress). Driven by its international business strategy, Cryo-Save's services are available in 40 countries across three continents (Europe, Asia, Africa).