A LEADER BIOTECHNOLOGY LAB IN MEXICO
The Unit of Development and Research in Bioprocesses, UDIBI, is a laboratory authorized by COFEPRIS that provides analytical services, design and development of new products, and consulting services for the pharmaceutical and biopharmaceutical industries, with a projection to expand its services portfolio to the environmental, agrochemical and food and drink industries. All these services are supported by a qualified multi-disciplinary team.More
THE FIRST BIOPROCESSES UNIT OF IPN AUTHORIZED BY COFEPRIS
Years of experience
OUR CAREER SUPPORTS THE QUALITY OF OUR SERVICES
Our team is integrated by people whose experience and knowledge allow understanding the needs of our clients to comply with their expectations.
We perform our activities according to global the higher quality standards, the Mexican Regulation and International guidelines from ICH, EMA and FDA.
ASAYS USED FOR CHARACTERIZATION AND COMPARABILITY OF BIOPHARMACEUTICALS
Our services are based on state-of-the-art techniques supported by the continue update of our team who participate in presentations, courses and symposia. In addition, our principal investigators and several of our collaborators are members of the National Researchers System (SNI), which supports their scientific career.
We conduct the design and development of bioprocesses for the production of new therapeutic recombinant-proteins. We also perform analytical methods for their physicochemical and functional characterization.
Our service is focused on the demonstration of critical quality attributes similarity of biosimilar candidates, through physicochemical methods and functional in vitro and in vivo assays in relevant models.
We are capable to conduct in vitro pharmacologic activity assays, including determination of affinity and biological activity; as well as pharmacokinetics, pharmacodynamics and cytotoxicity studies in in vivo and in vitro models.
We desing and optimize chimeric humanized monoclonal antibodies, proteins and vaccines using bioinformatics tools to provide our clients with functional and stable proteins throughout its shelf-life.
Our consulting services include: Regulatory pathway for biologic and biopharmaceutical drugs, analytical methods and process validation, and design and development of bioprocesses.
WE ARE READY TO SERVE YOU
Prolongación de Carpio y Plan de Ayala S/N
Colonia: Casco de Santo Tomas Delegación Miguel Hidalgo C.P 11340
Escuela Nacional de Ciencias Biológicas (ENCB) IPN.
Phone:+52 (55) 5729 6000 Ext. 62543