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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Not only has the $65 million investment in the Novartis-MIT Center for Continuous Manufacturing advanced the field of continuous processing and allowed the concept of end-to-end integration to gain more exposure, it has fostered the atmosphere for the creation of a spin-off company to support continuous processing initiatives. This company, called CONTINUUS Pharmaceuticals, designs and develops continuous processing initiatives for clients. Supported by automation control architecture from New England Controls, the company was awarded a Phase I Small Business Innovation Research grant from the National Science Foundation in January 2015. CONTINUUS was one of the 35 companies chosen by the National Science Foundation to exhibit its technology at the recent BIO 2015 meeting in Philadelphia, PA.
“What we are doing here is not just running real-time simulations for individual unit operations-we are running integrated advanced modeling in parallel with the control system to directly stabilize and control process parameters, which were previously not available to be controlled,” said Terry Seanard, manager of advanced services at New England Controls, in a press release. “This is an incredible opportunity to fundamentally change the way pharmaceuticals are manufactured at scale,” Seanard added.
The efficient processing and manufacture of medications are quickly becoming a focal point for FDA and pharmaceutical companies alike, and financial incentives to invest in the operational advantages of continuous processing are cropping up in various places. Companies and academic institutions that either study or "recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques” will be eligible for grants from the Commissioner of Food and Drugs of up to $5 million from 2016–2020, according to a directive in the 21st Century Cures Act that was passed on May 21, 2015 by The House Energy and Commerce Committee.
Bayan Takizawa, MD, MBA, co-founder and chief business officer of CONTINUUS Pharmaceuticals, Inc., told BioPharm International that the company's initiatives are tied to MIT, and many of its advisors and mentors, as well as one of its directors, are professors at MIT. He said, "We are affiliated with MIT through a license we have on several of the novel process technologies developed at the Novartis-MIT Center for Continuous Manufacturing." Takizawa said that while CONTINUUS' efforts are "independent of Novartis and their efforts in continuous manufacturing," the company looks "forward to the opportunity of collaborating with them on future projects." Takizawa added that the company is "currently looking into opportunities to participate in continuous manufacturing initiatives with federal agencies, such as the FDA," and is also in discussions with several potential clients about how CONTINUUS can apply its technology to the production of biologics.
Continuous biomanufacturing and perfusion are thought to offer cost savings within the range of 30–50%, which could translate into a cost reduction of 60% or more per gram of protein, according to sources. Continuous manufacturing is also associated with a 20–30% increase in resin utilization when compared with batch processing and, according to CONTINUUS, can lead to significant reductions (>90%) in lead time and footprint.