Two men slowly open a heavy steel door to reveal a bank of mysterious-looking compartments. Their faces obscured by protective masks, their bodies swathed in white plastic suits and gloves, they sign to each other to pull out a steel drawer packed with fluid-filled containers.
What looks like the opening sequence of a science fiction film is actually a scene from everyday life – played out in a laboratory in France. The two lab workers handle the precious material behind the steel doors very gently and carefully. These are substances that are used to make vaccines for Sanofi Pasteur. With its range of 45 vaccines, the company provides protection for babies, children, teenagers, and adults against 20 infectious diseases. It is the market leader in Europe and one of the top four vaccine suppliers worldwide.
The company’s history dates back more than 100 years, beginning in 1880, when Louis Pasteur developed the principle of using a weakened form of a disease to produce immunity to it. “Vaccines imitate pathogens without endangering the human body,” explains Eric Neyret, managing director of Sanofi Pasteur in Germany. “They resemble viruses and bacteria, but they no longer have the capacity to cause disease. You could say that we use vaccines to trick our immune system into thinking that we have an infection so that it can familiarize itself with the foreign agents attacking it, ‘remember’ them, and defend itself against them in the future.”
Proximity and standardization
Frenchman Neyret is not at his office in Lyon today: He’s in Leimen, at the headquarters of Sanofi Pasteur MSD’s German operations – just a stone’s throw from SAP headquarters in Walldorf. But it wasn’t merely proximity that made the company decide to opt for solutions from SAP. “First, we were looking for a standardized system that would give us long-term reliability and stability. And we wanted a European vendor because we needed a software solution for our European operations,” recalls Neyret. The company implemented SAP R/3 in Germany in October 1996 and at its other European locations a year later. Smaller subsidiaries that later joined the group were quickly linked up to the SAP system – Austria in 2001 and Switzerland in 2004. Sanofi Pasteur has kept its software state of the art through regular upgrades. “Currently, we are running SAP ERP 6.0 in inventory management, sales and distribution, financial controlling, and analysis,” reports Dirk Prehn, the company’s head of IT.
If you work in the vaccine business, you need a strong dose of staying power. It takes between eight and twelve years to progress from the idea for a vaccine to the finished, licensed product. Compliance with statutory requirements for quality, effectiveness, and safety is constantly accorded top priority – at the research stage, during clinical trials, and – once the vaccine has been licensed – in general, commercial use.
Quality control essential
Vaccines protect and save lives. But they must be manufactured in a sterile environment. Before a batch leaves the laboratory, it undergoes intensive testing. “Quality-control procedures make up 70% of the entire manufacturing process,” explains Neyret. While it takes just 20 days to manufacture influenza vaccine, he says, quality-control procedures add another 192 days to the tally.
“We’re selling a product subject to the strictest regulations,” notes Neyret. “Quality control is vital because we are vaccinating healthy people – often in very large numbers and within a short space of time.” Finished vaccines are transported to storage areas in coolers, where they are kept at temperatures of two to eight degrees Celsius before being dispatched to medical wholesalers and chemists. The cooling chain must remain unbroken throughout storage and transportation, so every delivery is documented meticulously. “Thanks to the central SAP system, we have precise details of when and where specific batches are delivered within Europe,” says Prehn.
The prolonged manufacturing process for vaccines makes predictive planning essential. Before the influenza season begins, for example, empirical values from previous years are used to determine the number of vaccine doses required. If a wave of influenza is particularly strong, more people will want to be vaccinated than in previous years – and there will be a sudden rush on influenza vaccines. In such cases, Sanofi Pasteur uses its SAP software to check its European stocks of influenza vaccine. It can then deliver vaccines to regions where there is an increased demand.
Teams of researchers all over the world are constantly working to develop new vaccines for the European market. Recently, Heidelberg-based researcher Professor Harald zur Hausen received the Nobel Prize for Physiology or Medicine for his groundwork in the development of a vaccine to prevent cervical cancer. “Our objective is to extend immunization protection to diseases for which there is currently no vaccine,” says Neyret. “We also want to improve existing vaccines in terms of their efficacy levels, how well they are tolerated by the human body, and their acceptance among the public at large.”