Resumen

VARGAS CABALLERO, Yordanka et al. Microbiological control in the large-scale production of ascitic fluid rich in monoclonal antibodies in Cuba. Rev Salud Anim. [online]. 2016, vol.38, n.3, pp.173-186. ISSN 0253-570X.

The obtaining of the monoclonal antibodies (MAb) in ascitic fluid (hybridoma technique) in Cuba is targeted to guarantee the production of recombinant anti-Hepatitis B vaccine. Given its necessary production free of contaminating microorganisms, its objective was to evaluate the effectiveness of the Microbiological Control Program implemented in production of ascitic fluid rich in MAb in Cuba.  For the program evaluation, microbiological (Chi-square, p<0.05), productive and quality indicators in the ascitic fluid production between Stage I (design and implementation) and Stage II (evaluation) were analyzed. A lower incidence of microorganisms isolated from ozonized drinking water (1-28%) and bedding material (3-12%) in Stage II was evidenced, compared to Stage I (8-41% from water and 8-38% on bedding material). Likewise, higher values in the productive indicators (MAb (mg/ml) 3.41 (Stage I)/6.73 (Stage II) and crude volume/engrafted animal (ml/animal) with 5.26 (Stage I)/7.05 (Stage II)) were obtained. Similarly, less quantity of Non-conformities and more Customer Satisfaction were obtained in the quality indicators analyzed (Stage II). The Microbiological Control Program implemented in the large-scale production of ascitic fluid rich in MAb in Cuba is effective, ensuring the consistency in the specified characteristics of the final product for its regulatory approval.

Palabras clave : Microbiological Control Program; ascitic fluid; MAb; Cuba.

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