Medical Device Daily
Biovest International (Worcester, Massachusetts), a majority-owned subsidiary of Accentia Biopharmaceuticals (Tampa, Florida), said the FDA has advised it that its AutovaxID device requires no further review by the agency, which decided the AutovaxID is used in the manufacture of biological materials only and is not by definition a “medical device.”
The company said that to the “best of [its] knowledge,” AutovaxID is the “first and only instrument” to enable “cost-effective” and scalable production of cells or cell-derived products such as monoclonal antibodies for personalized medicine applications. Other potential applications include production of vaccines to treat diseases, as well as stem-cell amplification for therapeutic use.”
“We were basically seeking the FDA's clarification or guidance on whether this needed to be reviewed or classified as a medical device,” Carl Cohen, PhD, chief operating officer of Biovest, told Medical Device Daily.
Since the FDA does not view it as a medical device, that would allow Biovest to begin commercializing the instrument as soon as it has completed its “manufacturing runs,” he said. However, because it is not classified as a medical device, the company also cannot make claims about the AutovaxID.
The instrument is scheduled to be available for sale in late 2006 with product delivery in 2007.
Biovest described the AutovaxID as a reusable device that “hosts a companion single-use, disposable, closed-system chamber containing a hollow-fiber cell growth cartridge. Cohen described it as a “third-generation follow-on to a very successful line of hollow-fiber, cell culture instruments that Biovest has been marketing under various names” for more than 12 years.
The AutovaxID is targeted to an entirely separate segment of the market – “that part of the market focused on the whole personalized medicine field,” he said.
“It's going to be servicing people who are interested in making small-to-medium batches of monoclonal antibodies, and by that I mean up to about a gram per run,” Cohen said.
To commercialize the product, Biovest is considering several options.
“Currently, we are manufacturing the new instrument in our Minnesota engineering facility,” Cohen said. “My guess is that the initial devices that will go out for beta testing and sale will be manufactured at that facility, but we are actively in talks with potential partners both for the manufacture and assembly of the instrument and its disposable.”
By automating the production process and using single-use, closed-system disposable cartridges, AutovaxID minimizes costly and error-prone manual monitoring and adjustments, the company said.
It reduces the footprint requires for such processes, since it is the size of a large coffee maker of about one foot wide, one foot and half long and two feet tall. In addition to reducing the need for more lab space, it reduces the need for clean rooms and isolation suites.
And while it may vary depending on the specific applications for which it will be used, Cohen said that Biovest had compared the AutovaxID to making monoclonal antibodies using “typical” technologies, resulting in a cost that is less than half of traditional technologies.
Monoclonal antibodies are “one of the key ingredients in modern diagnostic assays,” he said.
The thinking is that if a company “had to make dozens or hundreds of batches of monoclonal antibodies up to the gram level,” Cohen said, “this would be an instrument that would make your life a whole lot easier, cheaper, minimize your need to expand your laboratory, minimize your need to costly clean room space, [and] reduce your manpower needs.”
The company suggested that it will not have any trouble finding companies that need the instrument.
Biovest Chairman and CEO Steve Arikian said, “Our market research indicates a very robust demand from university, biotech, pharmaceutical and diagnostic clients.”
At Biovest, the AutovaxID technology is being used to produce BiovaxID, the personalized anticancer vaccine the company is developing in coordination with the National Cancer Institute (Bethesda, Maryland) in a pivotal Phase III trial.
On Thursday afternoon, Biovest reported that it was notified that the FDA has granted Fast Track status to BiovaxID, the company's personalized biologic therapeutic for follicular non-Hodgkin's lymphoma.