Resumen

APEZTEGUIA-RODRIGUEZ, Isabel et al. Risk management applied to the design of a new production process for an immunotherapeutic from the Center for Genetic Engineering and Biotechnology. Vaccimonitor [online]. 2022, vol.31, n.3, pp. 109-119.  Epub 01-Dic-2022. ISSN 1025-0298.

The study aimed at reducing risks in the design of a new production process for the active pharmaceutical ingredient of an immunotherapeutic produced at the Center for Genetic Engineering and Biotechnology. The failure mode and effects analysis were conducted by a multidisciplinary team from the center. Quality risk management was applied to the technology for obtaining a recombinant protein for diagnostic use that was proposed to be transferred to Technological Development Division. The risk analyses evaluated the greatest influence on low recovery and non-compliance with the immunotherapeutic quality specifications. The potential causes of the failures were: the insufficient number of vials in cell banks, the complex culture medium with components of bovine origin, the samples handling errors by the operators, the use of inappropriate equipment, the parameters of operation (agitation, pH and conductivity) outside specification limits affecting purity due to the high percentage of contaminants from the host; as well as, the inadequate filtering medium together with an incorrect preparation of the redundant filtration system in a non-sterile product. The actions could modify the technology proposed by Biomedical Research Division that allowed the design of a new production process of a biopharmaceutical product for the treatment of chronic viral diseases.

Palabras clave : life cycle; risk management; immunotherapy.

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