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in-PharmaTechnologist spoke with Stuart Porter from excipients and coatings firm International Specialty Products (ISP) who will participate in a panel discussion of continuous manufacturing at ExcipientFest Americas next month.
Porter said that while individual continuous processes such as tabletting and dry granulation are well established in the drug sector the growing trend is for producers to tie these together which poses new challenges.
Batch
One of the main potential hurdles, according to Porter, is the need to find new ways of defining a batch that are not reliant on a finite quantity of material weighed out and recorded on a batch record.
“Now rather than a quantity of materials used, a batch has to be thought of as a moment in time, whether it’s a 12or 24-four process.”
He also suggested that the characteristics of raw materials fed into continuous process may have to be altered to improve, for example, the accuracy with which they are introduced.
Regulatory role
He also said that regulatory guidance would be helpful and suggested that organisations like the US Food and Drug Administration (FDA) would support the principal of continuous manufacturing from a quality perspective
“I think they [the FDA] will embrace it because it fits with the whole concept of quality-by-design and PAT [process analytical technology]. A continuous process enables PAT initiatives… to be implemented more easily than some more conventional processes.”
Porter's suggestion fits with comments made by FDA compliance officer Francis Godwin during a presentation at Interphex 2011 in New York earlier this month.