FDA Approves Flublok Vaccine for Adults

Recently, the U.S. Food and Drug Administration announced it had approved Protein Sciences’ Flublok, the first trivalent influenza vaccine made using the company’s baculovirus expression vector system (BEVS) insect-based recombinant influenza hemagglutinin (rHA) technology. Flublok is approved for the seasonal prevention of influenza in people 18 through 49 years of age. According to Protein Sciences, approval for all people 18 years and above is pending and expected later in 2013.

Unlike most contemporary flu vaccines, Flublok eschews influenza virus or eggs to produce its vaccines. Instead, Protein Sciences’ technology allows for production of large quantities of the hemagglutinin (HA) influenza virus. The FDA said that while the technology is new to flu vaccine production, it’s been used to make approved vaccines that prevent other infectious diseases.

BEVS has been characterized as the “Killer App” for vaccines, largely due to the less costly and rigorous production environment required to manufacture it compared to traditional vaccines. Protein Sciences chairman Dan Adams agrees: “I think Flublok is a great product. And it is the poster child for the underlying technology. I saw the technology as being able to produce a multitude of vaccines rapidly, safely, accurately and for low cost. Those are the key things about this technology. If you want to really fully develop the market for a vaccine, you’ve got to be able to produce it at low cost.”

Protein Sciences investment and development of BEVS and its express SF+ line will continue to deliver dividends socially and monetarily. “I think that the key is … how broadly applicable this is to all kinds of vaccines, including a whole new line of vaccines that are going to be developed by some of our biggest customers,” said Adams, offering rabies vaccine as an example: “Rabies doesn’t occur in the United States. It’s very rare. It’s just rampant in India and parts of Africa, and yet they can’t afford $300 [per dose]. Our objective is to develop a rabies vaccine you can sell for $20-$30. And using our technology, it’s feasible to do that.”

The FDA has also been relatively enthusiastic, commenting specifically on Flublok’s production scalability in its announcement: “This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”

Protein Sciences, a vaccine development and protein production company located in Meridan, Conn., is ramping up production capability. According to Adams, “This year we expect to produce between 3 and 5 million doses … next year, we believe we can turn out up to 10 million doses. After that, we’re probably going to need some additional capacity … we’re working hard on that right now.”

Natoli Engineering and the Arnold and Marie Schwartz College of Pharmacy and Health Sciences at Long Island University (LIU) have formed a partnership to create The Natoli Engineering Institute for Industrial Pharmacy Development and Research. 

“The Natoli Institute will allow industrial scientists to join with academia to conduct meaningful research on problems associated with solid dosage forms and instrumentation,” said Professor Rutesh H. Dave, the graduate program director of industrial pharmacy and pharmaceutics at LIU Pharmacy and the principal investigator for the Institute. “It will also provide an opportunity for our students to work hand-in-hand with industrial scientists to gain real life experience.”

“The Natoli Engineering Institute for Industrial Pharmacy Development and Research will provide students access to world-class technologies and subject matter experts while providing fresh opportunities for students to investigate both long-standing and new formulations,” said Charles Kettler, Ph.D., director Natoli Scientific. “Students will be able to get hands-on experience with the tooling and get to know the ‘sticking and picking’ issues associated with low solubility molecules and other tough-to-form but common formulations like ibruprofen.” Kettler said students will also get a chance to help solve tableting and formulation issues associated with its clients’ products as well.

According to Kettler, the investment is “significant,” offering that Natoli will be funding the gutting and repurposing of one of LIU’s campus buildings and contributing a fully functioning tablet compression suite along with supporting systems to create a real-world tablet production environment. “Our contribution will include stipends and other financial support to support students and faculty,” said Kettler.

LIU Pharmacy Dean David Taft added, “This institute is a wonderful platform for our two institutions to collaboratively conduct research, develop products for brand and generic industries, and provide educational opportunities for current and future pharmaceutical scientists.”

The Natoli Institute will be located at the Brooklyn campus of Long Island University (LIU) and will be dedicated to advancing knowledge in the field of pharmaceutical solid oral dosage engineering operations and instrumentation, according to the company. Work will focus on understanding the numerous problems associated with the compression of tablets, the development of formulations for new and existing molecules, and the measurements required to ensure proper delivery of formulations to the tablet press and control of the tablet press.