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With Delays Expected for H1N1 Vaccines, Could Contract Packagers Still Help?

August 21, 2009 – 10:45 am

Packaging logjams are being blamed for an expected delay in H1N1 shipments this flu season.  Reports are that manufacturing capacity cannot keep up with vaccine production. But it is too late for vaccine manufacturers to order and install new filling lines to share the load.

“New lines aren’t realistic for this season,” says Tony Miller, marketing and communications supervisor for Bosch Packaging Technology (Minneapolis). “You can’t just flip a switch.”

Current filling lines can be optimized to hasten production, but only by about a small margin. And the process can’t be changed too much. Any time you change a packaging process, “you have to go through validation again,” and that takes time and money, Miller says.

Instead, vaccine manufacturers experiencing the logjams should look for contract packaging service providers with available capacity. Miller says that a number of contract packagers themselves geared up in advance to support increased filling volumes. “We have provided new change parts–star wheels, guides, and others–that enable these line operators to switch machines from one program to another to support different packaging volumes. These aren’t off-the-shelf parts. They are complex, because each machine to some degree is a custom machine.” The shortest turnaround time for ordering such parts is about four to five weeks, he adds.

With the additional parts, some contractors were able to take lines running at partial capacity and extend them to nearly 100%.

Manufacturers may also want to look in their own warehouses to see if they already have the needed equipment. “Sometimes machines are delivered, but never used–often left in the crate,” Miller says. Equipment is typically ordered during Phase III clinical trials, he says, but if the product fails, companies are left with an unutilized machine.

Manufacturers would still need to test and validate new filling machines, but they wouldn’t have to wait for a new machine to be built, which could take six months or more.

Miller doesn’t seem surprised about the strained packaging lines. “The industry has been running very lean these days,” he says.

Daphne Allen

  1. 3 Responses to “With Delays Expected for H1N1 Vaccines, Could Contract Packagers Still Help?”

  2. In May, Catalent Pharma Solutions announced that it was preparing “to deploy significant additional capacity for the multiple H1N1 flu vaccines currently being developed by its customers.”

    Catalent is one of the leading outsourcing providers of prefilled syringe filling for seasonal influenza vaccines at its recently opened Brussels, Belgium, facility.

    John Chiminski, President and CEO of Catalent, said, “Catalent is well prepared, poised and ready to help the global healthcare industry respond to the significant public health challenge that the H1N1 flu represents. We have unmatched surge capacity potential for nearly every major dose form, a broad geographic footprint, and the operational flexibility required to support the rapidly evolving industry demands.”

    “We are also acutely conscious of existing consumer and patient reliance on our customers, and thus on Catalent, for the thousands of other life-saving and life-enhancing products we produce every day,” Chiminski continued. “We have general preparedness plans in place to address situations like the H1N1 flu, which we are constantly updating and localizing as public health situations evolve. We currently believe these plans are adequate to ensure that our customers’ products continue to be available to improve the health of people around the world.”

    By dallen on Aug 21, 2009

  3. I think these delays may cause some people to unnecessarily panic. The virus has been blown out of proportion thanks to the media and not much of the public really understands how little a threat it poses.

    By Jess @ cartoning machine on Dec 22, 2009

  4. The best treatment for influenza infections in humans is prevention by vaccination. Work by several laboratories has recently produced vaccines. The first vaccine released in early October 2009 was a nasal spray vaccine. It is approved for use in healthy individuals ages 2 through 49.

    By Dental Lake Worth on Feb 5, 2010

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