Large steel tanks, supply pipes, a control screen in a very secure area: it is in a small room in the heart of a GSK factory at Saint-Amand-les-Eaux (North) that the adjuvant is manufactured to strengthen the effectiveness of some of the future anti-Covid vaccines.
The essential interest of the adjuvant? Mixed with antigen of vaccine, it intensifies the body’s immune response to the virus, explains the director of the Saint-Amand-les-Eaux plant Eric Moreau. ” This is extremely important in the context of a pandemic, because it will make it possible to put less antigen in the batches, to produce more doses and therefore to vaccinate more people and faster. ».
GSK has set a target of producing up to one billion doses of this adjuvant by 2021, to meet vaccine needs against the pandemic. Several hundred million must leave the northern plant, but other sites of the British pharmaceutical group, in Belgium and in the United States, are engaged in this race.
“The objective is to produce quickly and well”
The company did not wait for the results of clinical studies to start manufacturing. It started a major production this summer and plans to recruit and train around 100 people to increase capacity in the coming months.
« The restart of production of the adjuvant was anticipated. “And now” we are ramping up to move into two teams, then three teams, and possibly the weekend », Indicates Eric Moreau. ” The goal is to produce quickly and well ». « Our mission is to ensure that when the vaccine candidate is available, we have enough adjuvant to make available », Continues the director of the site.
This product is ” really specific, used only for the response to Covid-19 », But it is not for all that unknown since it had been employed during the pandemic of influenza H1N1 ten years ago and that the production tool was already used on the site.
The adjuvant will be supplied to laboratories developing anti-Covid vaccines with which GSK has established partnerships. The most important is with the French Sanofi, which could start the Phase 3 clinical trials at the end of 2020, the last step before an authorization request. But GSK also has agreements with the Canadian Medicago and the Chinese Clover Biopharmaceuticals.
The challenge for the Saint-Amand-les-Eaux site: to ensure this production in parallel with the usual production of the group’s vaccines. In 2019, the Saint-Amand plant manufactured 140 million units of vaccines, 95% exported to 125 countries around the world, and GSK invested in this major site more than 600 million euros between 2006 and 2013 .
To make the adjuvant, an oily solution and an aqueous solution must be mixed in a homogenizer and then filtered. The product is then stored in large bags of 500 liters. This process requires the respect of draconian rules and procedures, starting with clothing. Double overalls, charlotte, balaclava, goggles, gloves, special shoes and overshoes: the people working in the production area look like astronauts.
“Maximum quality level”
Manufacturing also requires highly skilled people. ” It is very technical equipment. There is a long training phase for our teams. It takes at least three months, and after three months, the person is still followed by ‘godfathers’ who accompany him until the day when he will produce alone. », Explains Elodie Plaisant, production manager.
Manufacturing is followed at each stage to have ” a maximum level of quality », Emphasizes Gaétan Legrand, production supervisor. ” All the documentation is checked, the products are checked, the raw materials are checked upon receipt, we carry out checks during production, and at the end of production we take samples which are analyzed in the GSK laboratories. ».
« Patient safety and the quality of what we do on the Saint-Amand site are absolutely essential », Insists plant manager Éric Moreau. Who specifies: ” there are no aluminum salts in the adjuvant ”, An element decried by some opponents of vaccines.
– .
