Stem Cell Therapeutic Product Articles & Analysis
5 articles found
All starting materials should have minimal microbiological contamination. Your contamination control strategy should document the quality of the materials in terms of microbiological monitoring or other requirements. The bioburden assay should be performed for each batch for both aseptically-filled products and terminally-sterilized products. Use the results as part of the final batch review. ...
Background Stem cells are naturally occurring cells in the body that have the ability to divide and produce a range of different cell types. They are important in the growth and development of the body as well as repair after injury. The past few years have brought a dramatic increase in the body of knowledge concerning stem cells, and their research and investment into uses in medicines1. ...
What are ATMPs? Stem cells are categorized as Advanced Therapy Medicinal Products (ATMPs) when undergoing substantial manipulation or when used for a different essential function. ATMPs are medicines for human use with gene, tissue or cell components. They can be classified into gene therapy medicines, somatic-cell therapy medicines, and tissue-engineered medicines, depending on how the medicine ...
One major challenge for implementing stem cell treatment in the clinics, is the interdisciplinary work required by stem cell biologists and medical doctors as well as the state-of-the-art equipment needed at public hospitals to successfully translate the basic stem cell knowledge into clinical ...
ByBaker
Stem cell research holds promise for applications in regenerative medicine. ...