CURRENT RESPONSE TO H1N1

In the case of the response to H1N1, the situation is not simple. The industry is increasingly able to develop vaccine manufacturing processes quickly, as evidenced by Novartis's June announcement that it had produced its first batch of H1N1 vaccine in cell culture.¹ The problems are related to how to rapidly ramp up production, particularly to make a billion doses of vaccine.

Ensuring sufficient supply of disposable components

Novartis manages demand by stockpiling a certain number of fairly standard disposable materials and components, says Tibor Nemes. In their hybrid setup, the disposables they typically use are aseptic connectors and biowelders, bags, tubing, and filters. But even Novartis cannot build up huge quantities of disposables ahead of time. "Inventory has to be based on production needs, so there has to be a balance," he says.

Rapid changeover requires standardized equipment

Another requirement in a pandemic situation is rapid product changeover—adapting an existing facility to a new process. This is an area where disposable technologies have an edge over stainless steel, but Nemes cautions users not to be overly confident on this point. "Rapid implementation of disposables may not be as rapid as we think," he says.

Because there is little standardization of components and assemblies, he explains, new assemblies require lengthy redesign and validation. "If you make a simple change to a bag design, the engineering review at the supplier side can take months," he says. "There is a need for standardization of disposable assemblies if we are to achieve a rapid reconfiguration of a facility."

The head of vaccine manufacture says that the lack of standardized materials is another impediment to rapid response. "The day that the major suppliers really get together and discuss working from a common materials platform, we can talk more seriously about strategic implementation into platforms such as flu," he says.

The Suppliers' Perspective

Many suppliers agree that standardization is needed. "If we want a quick response, habits of processing must change, to move away from customization to standardization," says Gunter Jagschies of GE. "There is no way that any supplier can make a business case out of, for example, customizing disposable columns."

When a disposable device gets complex and when you have to create housings around a functional piece of equipment, the economy that can be achieved from having a disposable solution can be destroyed, Jagschies says. "These routines and dogmas that companies have individually must be replaced with some level of agreement as to what the dimensioning of these devices and columns should be," he says.

Jagschies cited the Akta ready system as an example of standardization that is proving popular in the market place. The changeover time, including hooking up the column and putting liquid into the system, is two hours. "You can use the same standard system for a multitude of processes; traditional equipment needs a full working day," he says.

According to Parrish Galliher of Xcellerex, however, this time saving will only count if the technology is on the critical path. "Xcellerex has addressed the standardization of disposable technologies as far as practically possible at this point in time," says Galliher. "Any vaccine can be made with standard platform plastics. We have developed standard designs which are on a two-week lead time," he says.

"Unfortunately such lead times are not guaranteed on components such as filters, so not all components meet this two-week delivery time," says Galliher. To address this, Xcellerex is putting contracts in place with its major suppliers to ensure they keep a certain amount of inventory of critical components.