Converting an idea for a drug into a prescription is a complex process.
Since 2006, faculty and staff working at the Biopharmaceutical Manufacturing & Academic Resource Center, known as BioMARC at Colorado State University have been helping developers and scientists bring their ideas to the marketplace.
“BioMarc is a one-of-a-kind, BSL3 FDA-approved manufacturing facility that provides translational research and development of desperately needed medical countermeasures for biosecurity and biodefense,” wrote Alan Rudolph, who is vice president for research at CSU, in an email to the Collegian.
BioMARC specializes in products, called biopharmaceuticals, derived from biological sources that require careful handling and safety procedures. Some of these high-containment products are vaccines for infectious diseases, such as Ebola and HIV.
CSU is very unique in its investment in biopharmaceuticals, in the expertise on campus and in the recognition BioMARC has within the field, according to Dennis Pierro, director of BioMARC.
“They have been extremely successful at providing strategic biopharmaceutical manufacturing capabilities to a variety of product developers, such as private companies and government sponsors, and have developed a name for themselves and CSU in high biocontainment manufacturing,” wrote Dr. Rick Lyons, director of the Infectious Disease Research Center, in an email to the Collegian.
Pierro explained that companies, labs and developers come to BioMARC seeking development and manufacturing help for a vaccine or other biopharmaceutical. People often have a product that shows potential at the lab/research level for eventual use in human medicine, but are uncertain about how to get their product from the lab to the market.
“We fill the gap between somebody saying, ‘I already have a great idea, I’ve already built portions of it and I already have preliminary data that this is probably a lead candidate, but I don’t know how to move it to being ready for use in human clinical trials,’” Pierro said. “A lot of people get to that point, and the difficulty is finding teams like BioMARC who can get (the product) going to the next level.”
Pierro said the process of developing and manufacturing a biopharmaceutical for human use is complex. When BioMARC receives a contract to work on a product, they thoroughly review the preliminary research to determine if it is safe and will meet the Federal Drug Administration’s regulatory guidelines. Sometimes people come with a drug containing a chemical unsafe for humans and, therefore, can never be used on humans.
“We need to be very careful upfront about what type of products we want to put forward in a product development program, because if it will never get approved from a FDA regulatory perspective, then we shouldn’t do that type of development,” Pierro said.
Following the initial review, the team at BioMARC performs a series of increasingly regulated runs to ensure the materials and process are correct for making a particular product, and that everyone is properly trained. According to Pierro, risk is assessed throughout this process. He said they think about potential problems and how to solve them, so they can avoid doing an experiment twice.
“I think when people take drugs, they don’t fully realize that there are a tremendous amount of professionals in the U.S. (working on development and manufacturing),” Pierro said.
According to Lyons, BioMARC has trained a number of individuals, including CSU students, in the field of biopharmaceuticals manufacturing that have added to the workforce of Northern Colorado.
Pierro explained that students receive valuable hands-on, supervised training and experience while employed at BioMARC. Students leave the facility with a knowledge of working in a functioning pharmaceutical community and working in a regulated environment.
Pierro received his Ph.D. at CSU, and then worked in regulatory affairs at the National Institutes of Health in infectious diseases supporting development and manufacturing clinical trials. He said this experience was very beneficial to understanding the process of drug development and manufacturing. According to Pierro, he has always had an interest in the functional side of research and about how to actually get a product out there for people.
“Our goal is to manufacture a product, so that a doctor can pull it out of an inventory and give it to humans,” Pierro said. “We have to think all the way to that end.”
Collegian Science Beat Reporter Christina Dennison can be reached at firstname.lastname@example.org or on Twitter @csdennison.