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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
Prequalified manufacturing suites could benefit from a new business model, say some industry executives.
In emerging markets, end manufacturers would benefit from being physically closer to patients, industry experts said on Apr. 21, 2015 at INTERPHEX 2015 in New York, NY. This approach, perhaps best suited to smaller markets, could operate like a franchise, wherein multiple sites are making the same medication, noted Clark H. Byrum, Jr., president and CEO of Biologics Modular, a company that manufactures and sells modular facilities. The “sweet spot” for this type of implementation would be for small-scale, clinical batch sizes, such as specialty or orphan products.
During a session titled “Facility of the Future Will Not Necessarily Be a Facility,” Byrum mentioned that problems with in-country manufacturing have surfaced because of subpar contractors. “What is driving business is not how good our product is, but how bad construction overseas is,” he commented. He said that taking a McDonald’s or Ford approach to producing pharmaceutical products could be a valuable idea, although “regulators are still flushing out the pathway” for these types of activities.
The advantages of pods-including the fact that they can be assembled and qualified in a factory and redeployed to emerging or small markets-can save tens of millions of dollars in product transfer, commented McCoy Knight, national sales manager, GEA Process Engineering. In addition, operators and can be fully trained prior to shipping the podular system, he said. Craig Johnson, technical sales engineer, Walker Barrier Systems, suggested that efficiencies could be enhanced if a company brings the units closer to headquarters to train operators, and then ships them to the desired area.
Another innovative idea would be a pod-farm concept, said Knight, where personnel and space could be shared among various companies. Pods could be changed based on need. Coupled with continuous processing-another popular manufacturing trend-compact facilities are extremely flexible. “If you need a flexible batch size, because the market wanes” or because a product strength changes, it is easier to address these fluctuations when running processes continuously, noted Knight.
While cost is a common reason implementation of modular units continues to lag, Knight insists that when looking at a depreciation timeline, a pod will still be viable within 10 years. Even though retrofitting could also be an option, Johnson said that once manufacturers have a validated system, they typically “don’t touch it unless regulatory [agencies] makes them.” Byrum concurred that retrofitting is not very common: “Hybrids will exist, but a process has to be developed first, and then a facility.”
Another barrier to mass shipping of validated processing units could lie with the regulatory framework surrounding each unit. A physical address is often required for each unit, panelists noted, which can be problematic. On the topic of the requirement of a physical address, Byrum said, “It’s an open discussion with the FDA.”