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Are there FDA guidelines assessment

Customer Question

Are there FDA guidelines for toxicological assessment for impurities in stem cell products?
Submitted: 1 year ago.
Category: General
Expert:  Andy_PhD_DABT replied 1 year ago.
Hi, The short answer is "yes". Stem cell products come under the Center for Biological Evaluation and Research (CBER). Similar to drugs, there are regulations on what impurities (adulterants) are allowed and not allowed. For drugs this is call Current Good Manufacturing Practices (cGMP) and it sets up a ton of regulations that must be met. There are semester long college courses just on cGMP for drugs. Similar to drugs, there are Current Good Tissue Practices (cGTP) for tissue based therapies like stem cells (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM285223.pdf). The difference is that drugs are made from chemicals that you have a lot of control over in terms of purity, but stem cells have less control over purity since they have to come from a person who may or may not have a number of diseases and diseases and impurities could be introduced during processing of stem cells. The regulations cover pretty much everything involved in stem cell therapies, from documentation, to the buildings use, the processes and chemicals used, the people who can donate stem cells, how the stem cells are handled. Harmful chemicals will not be allowed in the final therapeutic product, viruses, bacteria, and other infectious agents will not be allowed, and harmful non-infectious biological agents, like endotoxin, will not be allowed. So there will be tight controls and tests for these adulterants will have to be done at multiple steps in the process, not just the final therapeutic product. So, any FDA approved stem cell therapy will have to meet very tight regulations to prevent adulterants (impurities). Now, as of now, the FDA has yet to approve any stem cell therapies. However, stem cell therapies can be used in experimental treatments, which do come under the FDA regulations and this is part of the process for getting a therapy approved. What usually happens is that during the early stages of therapy development, the cGTP requirements will not be 100% enforced since the FDA realizes that final manufacturing practices have not been fully established yet, but that isn't enforced is usually manufacturing processes and not adulterants. So even in this investigational stage, before the FDA gives approval, adulterants in the final therapeutic product are not allowed, though manufacturing processes may change at this point. Also, there is an ongoing effort to harmonized regulations of medical treatments throughout the world. The International Conference on Harmonization (ICH) was set up to coordinate this so that regulations in America, Japan, and Europe were the same (http://www.ich.org/products/guidelines.html). It's not 100% harmonized yet, but it's very close. So many FDA regulations will also apply to Europe and Japan. Drug companies spend tons of money and hire many people who's sole job it is to make sure these regulations are met. So the FDA regulations are complex and I would not be able to explain them all here. If you have a specific question I might be able to help you further, but truly FDA regulations encompass just about everything involve in developing and making a treatment and people spend their entire careers just to make sure FDA regulations are followed. I hope his helps. If you need me to clarify anything, just ask. Take care,Andy