Created in 2012 to perform preclinical studies for biologic and pharmaceutical products for the pharmaceutical industry, the Unit of Research and Development in Bioprocesses (UDIBI) is now undergoing a consolidation process to become a laboratory for preclinical, clinical, and biocomparability studies of biotechnological medications. As part of the installations of the National School of Biological Sciences of IPN, UDIBI aims to expand on the research goals of IPN and to link the results to other institutions.
Exclusive interview with Dr. Sonia Mayra Peréz Tapia, Executive Director UDIBI
Q: How did your involvement in the Transfer Factor Project lead to the establishment of the UDIBI research center?
A: Transfer factor has a long history in Mexico. When it was discovered in 1955, knowledge in the field of immunology was in its infancy, so when Dr. Sherwood Lawrence found that partial immunity to infectious diseases was transferred from immune cells to others, he believed only one molecule was responsible for that effect, which was designated ‘transfer factor’. Later on, as the field of immunology developed and the different biological processes were gradually understood, transfer factor remained a mystery. Respected Immunologist Dr. Sergio Estrada Parra met Dr. Lawrence at a conference about 40 years ago, and discovered that the transfer factor’s action was mediated by a mix of more than 1,000 peptides. In 1971 the first product was registered at the regulatory agency and 30 years ago Dr. Estrada started producing a small batch of this product from leukocytes of healthy people in the Escuela Nacional de Ciencias Biologicas of the Instituto Politecnico Nacional (IPN). I have been working on transfer factor for 20 years. In the project’s early stages, there was a great need for more preclinical studies and general development, but we quickly moved from producing 20 to 1,000 bottles of transfer factor a year, and now we are producing 500,000 bottles per year. The product has gained COFEPRIS approval in its injectable and oral forms and, due to it being obtained from leukocytes of human blood, strict guidelines and requirements must be complied with, especially for viral control. As the project continued growing, we needed a larger scientific staff to increase our production capabilities as well as to advance our knowledge of transfer factor and immunology. As a result we also started providing services for the biopharmaceutical industry, and so a designated research center was founded in 2012, called UDIBI.
Q: What is the main focus of UDIBI at this point, and how would you compare its standards on a national and international level?
A: We provide pharmacokinetics and pharmacodynamics in vitro studies for the development of biosimilars. Our biggest contracts are for providing biocomparability studies, as well as identifying several blood analyses for clinical trials, expert advice for scientific projects and regulatory affairs, and quality control tests. Our quality control standards set us apart and specific guidelines, norms, and ISO standards are implemented at UDIBI. It is difficult to find a laboratory in Mexico that works with Good Laboratory Practice, so we stand out in this regard. We are still too small to really compare ourselves to research centers in Europe and the US, but our quality services are the same as those from other universities in the world despite being cheaper. We can perform viral validations for biologics at one-tenth of the average price in US, which is about US$1-2 million. At present we provide two local companies with such services, and are negotiating with a multinational company for preclinical studies, validation, and proof of concept of different molecules.
This post is an excerpt of Mexico Health Review 2015, to be released in September 2015. To pre-order your copy click here. Please direct all media enquiries to [email protected].