5 Things You Need to Know about Continuous Pharmaceutical Manufacturing



Andrea Charles
11/15/2011

Continuous manufacturing is done in almost all manufacturing industries, except for wine, hard spirits, and pharmaceuticals. Defining a batch is up to the manufacturer but consistent with QbD, so why don’t they do it? It means change and change only happens when there is absolute need,” said Cristina Falcão, Pharma IQ Columnist in a recent interview with Pharma IQ.

Continuous manufacturing is gaining ground in the pharmaceutical industry. In the current economic climate many organisations are looking to make their manufacturing more cost effective and reduce inefficiencies with lean processes.

In 2007 Novartis and The Massachusetts Institute of Technology (MIT) set up the Novartis-MIT Center for Continuous Manufacturing to help realise these goals. With Novartis investing $65 million into the collaboration.
 
"We have a pretty ambitious view on continuous manufacturing," said Walter Bisson, global program manager of technical operations at Novartis at the time. "We're trying to invent new methodologies, which lead to new technologies, which can then be translated into new equipment."

In a recent article for WorldPharmaceuticalFrontiers, Bernhardt L Trout, professor of Chemical Engineering at Massachusetts Institute of Technology (MIT) said:  “Everyone is talking about continuous processing and there is a large push towards it.”

Due to the well-known conservative  nature of the pharmaceutical industry there is hesitation, however Trout maintains the belief that  the industry is ready for innovation and  there  is a strong case among pharma for continuous processing.
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“It is very exciting time for pharmaceutical manufacturing, and there is a great deal of enthusiasm that comes with innovation,” he said to WorldPharmaceuticalFrontiers.

Recently we asked Cristina and the broader pharmaceutical industry to discuss in an online  forum the economic impact of continuous pharmaceutical manufacturing , advantages of continuous over batch biomanufacturing and the key challenges of continuous manufacturing.  They came with the 5 things you need to know about continuous pharmaceutical manufacturing:

  • Continuous processes require smaller footprints and reduce equipment/resource expenses because they don't have the peaks, valleys, and slack cycles of batch processes. Imagine an oil refinery working on a batch basis and you'll see the obvious advantages
     
  • Implementation of continuous pharmaceutical processing, at least for drug products, requires a rare combination of technical skills which cannot be obtained by merely throwing pharmacists or chemists together with engineers
     
  • The Top 3 challenges of continuous manufacturing people, Not Invented Here (NIH) syndrome and understand what technology lies at the heart of continuous processing
     
  • It is really cost saving but it means “CHANGE” and that is the main problem because the majority of manufacturers don’t have a clue about the technology necessary, they hardly understand the current technology
     
  • The FDA has no problems with continuous manufacturing and says the definition of batch is up to the manufacturer as long as it follows the cGMPs.
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