Partial or Complete Vitrification for Cryopreservation of Living Stock Cultures of Mushrooms Used in Manufacturing Dietary Supplements
Effective June 25, 2010, all production of dietary supplements must comply with current Good Manufacturing Practices (cGMPs) published by FDA in the Federal Register (21 CFR Part 111, http:// edocket. access, gpo. gov/2007/07-3039. htm) in 2007. Under this rule, manufacturers of mushroom-derived dietary supplements are required to verify the identity of all components used to manufacture dietary supplements, and each manufacturer to perform its own testing or examination to verify the identity of each dietary ingredient prior to use in the manufacturing process. A well-defined and taxonomically determined starting culture used as a production inoculum is crucial for the success of dietary supplement manufacturing since it is the most important component of the production system, and without it there is no product. This source seed culture is absolutely essential in a series of aseptic manipulations that culminate with a sterile product and ensure the quality and safety of the finished product. Cryopreservation in liquid nitrogen (LN2) has been regarded as an efficient and reliable means of maintaining living stock cultures of various mushrooms with specific characteristics used in manufacturing of dietary ingredients. There are four successful cryogenic protocols employed at ATCC for long-term maintenance and preservation of mushroom cultures in LN2, which apply practical cooling rates by either partial or complete vitrification based on the dehydration procedures. These practical protocols are now being adopted by the China Center for Mushroom Spawn Standards and Control (CCMSSC) at the Chinese Academy of Agricultural Sciences (CAAS). With the cryogenic techniques and facilities available, ATCC is capable of offering cGMP safe deposit services that provide secure, confidential storage of living stock cultures of edible and medicinal mushrooms, focusing on regulatory compliance and control of facilities, equipment, process, and all documentation required by the new cGMP regulations for dietary supplement manufacturers.
Cryopreservation Vitrification Mushrooms Dietary Supplements cGMP
Shung-chang Jong Jinxia Zhang
Consultant for Global Affairs, ATCC, 10801 University Blvd, Manassas, VA 20110-2209, USA Institute of Agricultural Resources and Regional Planning, Chinese Academy of Agricultural Sciences,
国际会议
The 18th Congress of the International Society for Mushroom Science(第十八届国际食用菌大会 ISMS18)
北京
英文
714-722
2012-08-27（万方平台首次上网日期，不代表论文的发表时间）