Novartis looks back a year, recounting its filling and packaging scale up and navigation of the global cold chain.

When the World Health Organization declared the H1N1 pandemic in June 2009, Novartis was already busy preparing seasonal influenza vaccines for the 2009–2010 season. “We typically prepare 70–80 million doses for a typical season,” explains Matt Stober of Novartis Technical Operations. “We had to ramp up quickly to be able to provide an additional 150 million doses of H1N1.” In total, Novartis produced over 200 million influenza vaccines.

Novartis also had to find a way to move those added 150 million doses through the global cold chain, which under normal conditions is a challenge given the short season and the nature of the activity, he adds. Novartis had to quickly mobilize its network of in-house operations, contract fillers and packagers, and components providers. “Everyone reacted quickly, so we consider it a success,” Stober says.

Having a business continuity plan in place prepared Novartis for a pandemic. Nonetheless, the global company learned first hand what worked, and what simply looked good on paper. “When executing our plan, we learned that it pays to have regulatory work done in advance, much of which we had already done,” he says.

For instance, Novartis had already had a prepandemic product for Influenza A H1N1 approved in Europe called Focetria. But it did not have one approved in the United States. “This made the process more unpredictable, but we were able to do it,” says Stober. Overall, “regulatory authorities were very responsive.”

To more than double its output, Novartis brought on new secondary lines around the world with an abbreviated regulatory campaign. Seven sites and 11 different products and presentations sites were soon busy formulating, filling, and packaging, including DSM, Sandoz Fill and Finish, and Catalent Pharma Solutions (Belgium). “We worked with regulatory authorities such as FDA and EMEA to bring on this capacity, and the regulators were responsive in terms of scheduling inspections and accepting our documentation,” says Stober.

Novartis primarily used existing packaging formats, but it needed two to three times the amount of vials, syringes, cartons, and inserts. Having secondary packaging suppliers qualified in advance helped Novartis maintain an aggressive timeline. “We had some inventory, but we did need more. Everyone was able to meet our deadlines,” he says.

For instance, BD and Helvoet Pharma met Novartis’s requirements, even though “syringes, stoppers, and over seals are the most challenging components,” says Stober. “We could not have done it without their help. They stepped up to respond.” Also, Novartis had qualified Ompi (Italy) in advance, and it was worth the extra effort. “Ompi is growing and very supportive,” he says. “It was important to our success to have qualified a secondary component supplier in advance of a crisis.”

Novartis did have to move component volumes around to meet market requirements. For instance, some markets only accept single-dose prefilled syringes, such as Germany and France, while the United States and WHO-supported countries prefer multiple-dose vials, he says. In the United States, “doctors prefer multidose because they do not have room in their offices for high volumes of prefilled syringes. And in other low-volume markets, multidose vials are not good. It is a real challenge to keep up with individual market needs, especially in the event of a crisis.”

Novartis did need to make some changes to be able to support the increased volumes. Novartis worked with its existing leaflet supplier Tepo Services (Italy) to change the leaflet format. “Normally, we would put one PIL [patient information leaflet] in each brick,” he says. “In this case, we turned to PIL pads so each customer had a leaflet with their dose.” Ten multidose vials are packed in each brick with ten doses per vial.

To navigate the cold chain, Novartis had done some advance scenario planning. However, it learned that having cold-chain warehouse capacity in each country is key, says Stober. “We had a large network within Novartis, but we needed more and had to qualify and validate it quickly. We are now going back after the pandemic doing a ‘lessons learned’ on the critical supply chain.”

Novartis used reusable shipping systems through Lufthansa and United Airlines, utilizing TempTale data logging systems.
In the United States, Novartis had an existing partnership with UPS, Stober says. “We ship our products to UPS for storage in UPS warehouses, and then UPS moves orders to our distributors using refrigerated and GPS-monitored trucks. The system worked fairly effectively even with these higher volumes.”

In Europe, the cold chain was more challenging. “Shipments were delivered to pharmacies, where patients purchase doses and take them to their doctors for administration. A lot of learnings came out of this for a future process,” he says.