Not since the 2009 RV144 vaccine efficacy trial in Thailand has there been so much excitement about the development a HIV-AIDS vaccine.
Dr. Martin Montoya is a molecular biologist with the Molecular Science Research Center at the University of Puerto Rico, and Dr. Abel Baerga Ortiz is a biochemist with the University of Puerto Rico School of Medicine in the Department of Biochemistry.
Montoya and Baerga are key players in a collaborative partnership between recognized health and research organizations, the Academia, the local Government and the private sector for research and development for the generation of a prophylactic vaccine to fight HIV-AIDS, supported by the government of Puerto Rico. The ambitious project is intended to further transform Puerto Rico from a manufacturing e
Global collaboration draws upon regional expertise
Globalization is a critical strategy for the drug development industry, and Latin America is a robust emerging market which has drawn a lot of interest in recent years thanks to government support and incentives in many regions, as well as specialization in scale-up manufacturing, production of biotech crops, and expertise in medical devices and biologics.
Puerto Rico is historically a hub for production of pharmaceuticals and biopharmaceuticals/biologics, with many operations from major pharmaceutical companies located on the island. Yet despite the large scale manufacturing taking place in Puerto Rico, there has not been a lot of activity in developing product pipelines. A lot of companies have process development centers here in PR, but many processes come from the US headquarters of pharma companies.
The establishment of key infrastructure for the project was created in the Molecular Science Center, enabling Baerga and Montoya to make critical strides toward innovation to drive creation of new products and new solutions for major healthcare products—and their biggest initiative, the global development phase of a vaccine against HIV.
“What differentiates this project is the innovation is happening in Puerto Rico,” said Baerga. “With the HIV vaccine project, many methods used to assess the quality of vaccines are methods being developed at the University of Puerto Rico (UPR). These methods have resulted in an increase in yields of vaccine candidates, with some of the development taking place at CDI Labs Inc. and UPR.”
The phone call
“It all started with a phone call from the White House to Dr. José Lasalde, the interim President of UPR, due to his expertise in HIV receptors,” said Montoya. “Dr. José Lasalde was asked to put a consortium together, and convinced the White House of Puerto Rico’s advantage in manufacturing biologics. Dr. Lasalde enlisted CDI Laboratories to optimize the expression of the vaccine candidates in bioreactors. He got Amgen to advice in Mammalian gene expression (90% of Amgen’s worldwide production of biologics takes place in here).” Eli Lilly was also brought in to help with downstream purification of the process, and the project was launched with funding from the Puerto Rico Science, Technology and Research Trust, from PRIDCO, the government economic development agency looking to bring industry to PR, and the NIH.
“One of the details about the project is these vaccines are based on the envelope protein from the virus,” said Baerga. “The protein is a unique type of molecule; it is a glycoprotein, a mix of protein and the sugars attached to it. This is not strange as many proteins are like this, but in this case there is more sugar than protein, which makes the vaccine difficult to produce. In contrast, monoclonal antibodies may have two glycoprotein attachment sites. “Our protein has 25-26 glycan (sugar) attachment sites,” said Baerga. “This is a very different compound than what industry is used to dealing with.
“This is basically ground zero,” said Baerga. “We have to start from the bottom up in order to start processing vaccine candidates to scale-up and ensure that they have the level of quality required for clinical trials. This is an entirely new type of compound.”
A ready support system
Puerto Rico’s infrastructure has been developed for analysis of this protein. UPR spent time building the Molecular Science Research Center, with many new faculty recruited within the last four to five years with expertise in areas related to the project such as biochemistry, protein production, glycobiology and pharmaceuticals. In this regard, UPR’s investment in the project is significant.
As well, the climate for innovation and startups in Puerto Rico is ideal, as seen in the creation of new and novel research and manufacturing companies. The climate for startups has increased tremendously the last few years, and it has favored development of projects like the HIV vaccine.
Amgen is a key partner in the project for process development, donating equipment and expertise critical for the scaling up of cell cultures. Eli Lilly is also a partner, having donated equipment and expertise in protein purification. “Those are our main investments from pharma. These are not really investment relationships but rather knowledge transfer. These are public projects with public institutions, and they are enabling partners,” said Baerga. “As well, we have had major improvements to our infrastructure added from CDI Labs. The production of glycoprotein was not part of their original business model, so CDI have had to make major innovations to their space which required a substantial investment as publicly funded sub-awardees.” (Recently, the NIH awarded the vaccine project the first Super R01 grant in Puerto Rico, in the amount of USD 8.5 million for the next four years.)
In addition to Lasalde and Baerga, the project team at the University of Puerto Rico consists of four PhD-level researchers (Pearl Akamine, Coral Capó, José González & Manuel Delgado), one grad student (Mayteé Contés) in PhD project-based work being done on the vaccine, plus personnel at CDI Labs.
How close are we, really?
“We know what not to do, and in the big push for a vaccine against HIV over the years, there are many reasons why none have worked,” said Baerga. There was a major effort failing in 2009, and clinical trials done in Thailand showing some protection, but it was not sufficient protection to be considered a vaccine. Many papers came out of that study as to why that vaccine may not have been highly protective. The result is a new generation of the vaccine based on results of that trial. “This project will focus on a fundamentally different construct,” said Baerga.
Why Puerto Rico?
“If I could give one message to companies,” said Baerga, “I would say that Puerto Rico is much more than a manufacturing destination. Many companies have come to talk to us about manufacturing operations, and come to realize that there are many points of overlap in interest. There are a lot of researchers available here to go beyond manufacturing to R&D.”
“Of course, we also have experts in manufacturing sciences,” said Baerga, “who are willing and eager to engage in areas important to manufacturing, but we also have experts in pharmaceutical design, testing and clinical trial units (CTUs). “ We have a lot to offer to companies all along the pipeline. From basic science to clinical trials, Puerto Rico has the right infrastructure and support to increase their business.” Puerto Rico boasts the second largest FDA office after the US.
“Everything we do here, all the trials, physicians, are vetted by US FDA and regulatory agencies,” said Montoya. “If companies are looking for a place to bring technology from other countries to the US market, this is one of best places to initiate it.”
Puerto Rico has a strong history of compliance and regulatory processes based on their manufacturing industry. It is easy for a company to set up shop here and have access to well-trained experts to bring their products to the US and abroad, along with many tax and economic incentives.
Biolatam® international life science partnering conference taking place in Puerto Rico this November is a strategic way to gain instant access to Puerto Rico innovation, and to companies across Latin America, and to meet researchers from University of Puerto Rico involved in the HIV vaccine project.
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Editor-in-Chief, InsightFollow on Twitter More Content by Erin Righetti