Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit.

Following successes of authorized chimeric antigen receptor T-cell products being commercially marketed in the United States and European Union, product development of T-cell-based cancer immunotherapy consisting of cell-based advanced therapy medicinal products (ATMPs) has gained further momentum. Due to their complex characteristics, pharmacological properties of living cell products are, in contrast to classical biological drugs such as small molecules, more difficult to define. Despite the availability of many new advanced technologies that facilitate ATMP manufacturing, translation from research-grade to clinical-grade manufacturing in accordance with Good Manufacturing Practices (cGMP) needs a thorough product development process in order to maintain the same product characteristics and activity of the therapeutic product after full-scale clinical GMP production as originally developed within a research setting.

The Stem Cell Research and the Aging of Brazilian Population.

The developing countries are experiencing a shift in the population profile, faster than that experienced by developed countries, especially due to the consolidation of health practices and technological advances. These social changes also imply new socioeconomic models, able to escort social demands caused by the growth of the elderly population and the decrease in young economically active population. Several countries seek for actions that do not marginalize the elderly, and invest heavily in new technologies to ensure health access and active participation of this group in society.