FDA calls on manufacturers to begin switch from batch to continuous production


Source: http://www.in-pharmatechnologist.com/Processing/FDA-calls-on-manufacturers-to-begin-switch-from-batch-to-continuous-production

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Photo courtesy of Novartis-MIT Center for Continuous Manufacturing

Photo courtesy of Novartis-MIT Center for Continuous Manufacturing

Though making the switch from batch to continuous manufacturing may be difficult, costly and time consuming, pharma manufacturers and CMOs should begin to consider the switch as in the long-run it will end up saving companies time, money and space, FDA’s CDER Director Janet Woodcock told congressmen in a hearing Thursday.

Woodcock’s answers on continuous processing come as a new draft House bill calls on the Commissioner of the FDA to “award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.”

Woodcock received a few questions asking to compare the differences between batch and continuous manufacturing and after explaining the fundamentals, said, “I don’t know why it’s not more widely used” as “this is the future.”

She noted that what’s holding back innovation is that companies making the switch from older manufacturing processes will have to receive FDA approval.

Continuous manufacturing also could be a way to bring manufacturing jobs back to the US because it requires less space than batch and other manufacturing processes, she added.

However, Woodcock warned that generics manufacturers may be slow in adopting continuous manufacturing because “there’s going to be an entry cost that’s high.”

Industry Moves

Similar to Woodcock’s comments, the Novartis-MIT (Massachusetts Institute of Technology) Center for Continuous Manufacturing notes that the benefits of continuous manufacturing include:

  • Requiring the use of smaller production facilities with lower building and capital costs;
  • Minimizing waste, energy consumption, and raw material use;
  • Monitoring drug quality on a continuous basis rather than through post-production, batch-based testing; and
  • Enhancing process reliability and flexibility to respond to market needs.

Bernhardt Trout, Director of the Novartis-MIT Center for Continuous Manufacturing, told us that he thinks the push from Woodcock is in part “mindset momentum.”

The whole industry is discussing [continuous manufacturing.] The other issue related to mindset is that companies have to change the way they are doing Process R&D, and that takes effort,” Trout said.

He added that he’s discussed with the FDA applying for these grants to study ways to improve continuous manufacturing but he doesn’t have current plans to apply for them.

Back in 2013, GlaxoSmithKline became one of the few major drugmakers to make a serious commitment to continuous manufacturing, with a $50m investment in a Singapore plant.

More recently, Vertex Pharmaceuticals began building a $30m, 4,000-square-foot continuous manufacturing facility in Boston. J&J also has a line at a facility in Puerto Rico that it hopes will use continuous manufacturing.


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