Integración Clínico-Patológica 3 - ME164 201901

El curso Integración Clínico Patológica 3 es un curso de especialidad de la carrera de medicina, de carácter teórico práctico, que se dicta a los estudiantes del 8vo ciclo de la carrera de medicina y que contribuye con el desarrollo de la competencia general Pensamiento Crítico (nivel 3) y la competencia específica Profesionalismo - aprendizaje autónomo y desarrollo profesional (nivel 3). A través del curso los estudiantes integran los mecanismos fisiopatológicos con la patogénesis y manifestaciones clínicas de los problemas de salud que se abordan en relación al sistema vascular y corazón, enfermedades inflamatorias, enfermedades infecciosas, entre otras. La comprensión de esta integración permite a los estudiantes establecer las bases del diagnóstico clínico y las pautas del manejo de los problemas de salud abordados

Cell Banking of HEK293T cell line for clinical-grade lentiviral particles manufacturing

Background: Cell banks are widely used to preserve cell properties as well as to record and control the use of cell lines in biomedical research. The generation of cell banks for the manufacturing of Advanced Therapy Medicinal Products, such as cell and gene therapy products, must comply with current Good Manufacturing Practice regulations. The quality of the cell lines used as starting materials in viral-vector manufacturing processes must be also assessed. Methods: Three batches of a Master Cell Bank and a Working Cell Bank of the HEK293T cell line were manufactured under current Good Manufacturing Practices regulations. Quality control tests were performed according to product specifications. Process validation includes the training of manufacturing personnel by performing simulation tests, and the continuous measurement of environmental parameters such as air particles and microorganisms. Cell number and viability of cryopreserved cells were periodically measured in order to define the stability of these cellular products. Results: All batches of HEK293T Master and Working Cell Banks met the acceptance criteria of their specifications showing the robustness and homogeneity of the processes. In addition, both Master and Working Cell Banks maintained the defined cell viability and concentration over a 37 month-period after cryopreservation. Conclusions: Manufacturing cell banks under Good Manufacturing Practice regulations for their use as raw materials or final cellular products is feasible. HEK293T cell banks were used to manufacture clinical-grade lentiviral particles for Chimeric Antigen Receptor T-cell based clinical trials