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ISSN 1027-2852 (Electronic)
ISSN 0864-4551 (Print)

2015, Number 4

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Biotecnol Apl 2015; 32 (4)

Quality risk assessment due to the introduction of a new fermentation process in a certified multiproduct facility

García-Suárez J, Quintana-Esquivel M, Zumalacárregui LM, Rodríguez-Moltó MP, Suárez-Pérez Y, Cruz-Gutierrez O

Language: English
References: 24
Page: 4401-4406
PDF size: 311.48 Kb.


ABSTRACT

The development of Genetic Engineering has made it possible to obtain a large number of novel molecules expressed through the recombinant DNA technology in Escherichia coli. After selecting the producing strain, preparing the cell banks and designing the production process to obtain the active ingredient, while meeting the quality standards according to the pharmaceutical form that will be used, clinical studies are required to demonstrate the proof of concept and safety. Clinical assessments are then required in human beings, and Good Manufacturing Practices (GMP) must therefore be met to ensure product quality and safety for the patient. This paper shows the application of the quality risk assessment on introducing a new fermentation process to obtain a novel product in a certified multiple product plant. Risk assessment was therefore applied, using quality tools and basic observation techniques. The potential faults involved in the introduction of this new technology were identified and assessed. In this case we identified intermediate risks for the quality of the process, which will be mitigated during technology transfer, and low risks for the facility. Therefore, this production may be carried out within this production facility, which will save resources and time.


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