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GMP Certification Awarded to Cryo-Save Lab, India
Zutphen, The Netherlands (ots/PRNewswire) - Cryo-Save becomes the first stem cell bank operating in India to receive the WHO-GMP certification
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."
Cryo-Save, the leading international family stem cell bank, already stores more than 185,000 samples from cord blood and umbilical cord tissue for newborns and adipose tissue for adults. These stem cells can mean the difference between life and death in the case of future threats to the health of the donors. There are already several diseases that can be cured by the use of stem cells, and the number of treatments will only increase. The use of stem cells from adipose tissue is increasingly popular in plastic surgery. Driven by its international business strategy, Cryo-Save is now represented in over 40 countries on four continents, with ultra-modern processing and storage facilities in the United States, Belgium, Germany, Dubai, India, South Africa and France (validation in progress).