Current Synthetic and Systems Biology
Open Access

QbD for downstream process development of CIGb 550-E7, active pharmaceutical ingredient of HPV candidate vaccine

International Conference on Synthetic Biology

September 28-29, 2015 Houston, USA

Miladys Limonta Fern�?¡ndez

Center for Genetic Engineering and Biotechnology, Cuba

Posters-Accepted Abstracts: Curr Synthetic Sys Biol

Abstract :

Nowadays the biopharmaceutical sector is focuses on the need to implement quality systems based on the real time data and deeper understanding of manufacturing process since the development stage. Quality by Design seems to be the â�?�?good choiceâ�? due to its manufacturing design philosophy that increases the upfront experimentation and continuous monitoring in order to the establishment of the design and knowledge space where the control process and good quality product will be a guaranty. The CIGB 550-E7 is a fusion protein comprising the HPV16 E7 antigen fused to a cell penetrating and immunostimulatory peptide which corresponds to the carboxy terminal region of LALF 32-51. Previously we demonstrate that CIGB 550-E7 induces a potent antitumoral response against E7 expressing tumors, therefore could become a promising vaccine candidate for the treatment of HPV 16 related malignancies. This talk describe the process development to obtain a final product with CIGB 550-E7 as an active ingredient based on the implementation of QbD. It helped us to build the knowledge space and get information about critical, non- critical attributes and process parameters and also encompasses the design space and normal operating ranges as well as areas where the CIGB 550-E7 it is known that unacceptable product is produced.

Biography :

Email: miladys.limonta@cigb.edu.cu