Testing Biotech Drugs, Immunogenicity and Gene Therapy

Q: What relevance do third-party testing laboratories have in the market and what position do they hold?

A: Third-party testing laboratories add efficiency to the pharmaceutical supply chain, as companies like LEI support COFEPRIS’ operations in medicine and medical device assessments and analysis as well as clinical activity validation. LEI eases the agency’s oversaturation, ensuring the availability of medicine, but it has not been able to take part in the vaccination sector. All medicines can be considered matters of national security and vaccines reach over 90 percent of Mexico’s population, having a larger impact on our society in the event of a quality breach. Another problem arises as public health institutions lack vaccine availability, which could be the result of providers not delivering punctually, a lack of vaccines in their portfolio or COFEPRIS not releasing and distributing them quickly enough. LEI could contribute to improving these circumstances. With Mikel Arriola’s new position as head of the Mexican Institute of Social Security (IMSS), we expect the federal government’s health sector to allocate more activities of this kind to third party testing laboratories.

Q: What competitive advantages can the company offer over other testing labs?

A: We are the only laboratory in Mexico that analyzes biotechnological and biological products on a regular basis. We structure our technology based on clients needs, who are mostly players in transnational industry. As such, the knowledge and technology that LEI has adopted follows first-world and top-notch standards, resulting in business retention from all companies that supply biotechnological products in Mexico.

Q: What specialization areas does LEI foresee to grow the most and impact the company’s profitability?

A: From a trial number standpoint, the medical device sector will see the biggest change as it is growing exponentially. For instance, from 2014 to 2015, LEI saw a 40-percent growth in medical device sampling. However, the biocomparables sector will have the most impact on LEI’s operations, representing a 10 to 15-percent increase in sales. Our market share participation falls short at 20 percent because COFEPRIS enabled investigation institutions in these types of studies, including the Biotechnology Institute, the National School of Biological Sciences (ENCB), CIATEC and UNAM’s Chemistry Faculty. Although our market share took a hit, the positive effect they will have on Mexico outweighs our own interests. Unlike the institutions, LEI is subject to normal procedures and protocols. Despite seeing a slightly reduced cash flow, the company established added-value mechanisms that minimized negative impact on our business.

Q: What innovations will LEI release in the midterm?

A: We are working on different specialization fields, one of which advances methods to predict a drug’s immunogenicity. A large proportion of biotechnological drugs produce immunogenicity, such that the human body detects and adversely responds to them. In those instances, the biocomparables molecule must react with the same intensity as the innovative molecule, otherwise it could harm the patient. Traditionally, the immunogenicity stage is evaluated as far as the clinical trial phase, but LEI is developing models that can predict the molecule’s immunogenicity in preclinical trials. Gene therapy quality control is another field of study in which LEI innovates. Only four gene therapies have been approved worldwide. Locally, the same technology and expertise used in gene therapy studies is applied in biotechnological products, wherein we have a strong foothold. Finally, nanotechnology has become one of LEI’s focal points. We are working alongside our partner to develop a nanotechnology-based medical device.

Q: What challenges is the company facing?

A: Regulations have become the industry’s bottleneck. Years ago, LEI created a proposal to evaluate qualitycontrol processes in cellular therapies. To our surprise, we realized that Mexico lacked regulation in this matter. Thereafter, LEI referred to the European Medicines Agency (EMA) and the FDA. We evaluated their regulatory practices and their stance in such matters, which helped us build the guidelines to our proposal.