November 8, 2017

Understanding the complexity of vaccine manufacturing

Sanofi recently announced a 170-million-euro investment at its plant in Val de Reuil, France.  This investment will help Sanofi expand the coverage of flu vaccination around the world by producing the next generation of flu vaccines, fighting against four strains instead of three.

 

Understanding the complexity of vaccine manufacturing
Sanofi recently announced a 170-million-euro investment at its plant in Val de Reuil, France.  This investment will help Sanofi expand the coverage of flu vaccination around the world by producing the next generation of flu vaccines, fighting against four strains instead of three.

Manufacturing vaccines is a complex journey. It takes between 7 to 36 months to produce, package and deliver vaccines to those who need them. It includes testing each batch of vaccine at every step of its journey, and repeat quality control of batches by different authorities around the world.

Manufacturing vaccine is a biological process where a very high level of expertise is required. We need to continually adapt production process to satisfy evolving regulatory demand which varies country by country.

In addition, the production process is under even greater pressure as demand for certain vaccines grows, such as pediatric combination vaccines and as demand increases from the global public health community to investigate new and emerging threats.

Sanofi top priority is to provide vaccines to protect people’s health and we do everything we can to quickly resolve any supply issues that delay us in delivering on this priority. We believe in a world in which no one suffers or dies from a vaccine preventable disease.

In order to achieve that goal, Sanofi has implemented an ongoing investment program in building internal production capabilities.

You will find below an illustration of that complex manufacturing cycle :

3 questions for Vincent Hingot, Head of Vaccines Industrial Affairs

  • How extensive is Sanofi Pasteur’s industrial network?

Our industrial network now consists of 12 sites, including 3 in France, 3 in the United States, 1 in Canada, 1 in Mexico, 1 in Argentina, 1 in China, 1 in India and 1 in Thailand. This allows us to produce more than 1 billion vaccine doses per year.

We are one of the only global companies able to produce a wide range of vaccines against 22 infectious diseases. We are always looking to increase our production capacity to respond to the rising demand for vaccines throughout the world. In this sense, we are a vital partner for public health.

  • How does vaccine production differ from that of medicines?

In the vaccine field, “the product is the process.” This is unique in that, at the regulatory level, the manufacturing process must be registered, not just the product. With every minor modification of the manufacturing process, we must resubmit the marketing authorization file to the health authorities in each country.

The release of batches is an additional complexity because we validate them within Sanofi Pasteur, then the health authority of each country conducts its own testing before releasing the batch.

  • What are the technical difficulties?

We work on viruses, “living” bacteria or cell culture. We attenuate or modify the functionality of these raw materials so that they can help the immune system to recognize and fight the true pathogens. These living organisms are less stable than synthetic pharmaceuticals. This is why, for example, you have to keep vaccines refrigerated. The complexity of working with living organisms increases the time required for vaccine production with several quality control tests.

In addition, a vaccine is administered to a healthy person, which implies high quality standards. In recent decades, monitoring throughout the manufacturing process has increased. Today, we spend 70% of production time performing quality tests.