Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.

The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered.

Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use.

Design and implementation of an environmental monitoring program is vital to assure the maintenance of acceptable quality conditions in a pharmaceutical manufacturing unit of human mesenchymal stem cells. Since sterility testing methods require 14 days and these cells are only viable for several hours, they are currently administered without the result of this test. Consequently environmental monitoring is a key element in stem cell banks for assuring low levels of potential introduction of contaminants into the cell products.

Rheological behavior of gels and meloxicam release.

The aim of this work was to identify a gel with suitable organoleptic and rheological properties (spreadability, texture and viscosity) for topical administration, designed to allow fast release of the active principle. The release of Meloxicam (anti-inflammatory agent) from olive oil lipogels was compared with a Carbopol hydrophilic prepared gel. In order to improve the diffusion of the active principle, two different artificial membranes with different pore size were used, before release assays in diffusion cells were compared.