Builders of the COVID-19 vaccine production facility did everything possible to ensure project quality and speed
The office building of Beijing Institute of Biological Products Co., Ltd. (BJIBP) under China National Biotec Group (CNBG) in Beijing’s southeastern outskirts was still brightly lit at 9:00 p.m. on December 25, 2020. Dong Jianchun, head of engineering support, his deputy Shi Wei, and technical team leader Zhang Yu were feverishly pouring over a design plan for the company’s second production facility for the inactivated COVID-19 vaccine. They were checking implementation details related to the project as construction work entered the final stage and testing of production equipment was about to commence.
Working around the clock had become the norm for Dong and his team over the year. Within months after the pandemic outbreak, they completed construction of China’s first COVID-19 vaccine production facility to pass biosafety inspection and obtain a manufacturing license. To meet surging vaccine demand, the second such facility, with a steep increase in designed output capacity from 100 to 120 million doses annually to 800 million, will soon be delivered. “I am proud to be a part of this construction team,” Dong said. “Working for a major vaccine supplier means it is my duty to rise to whatever challenge when the situation demands.”
Vaccination is one of the most effective ways to prevent infectious diseases. During the global health crisis caused by COVID-19 pandemic, BJIBP has invested heavily in vaccine development and production.
In response to the sudden outbreak in mid-January 2020, the company’s COVID-19 vaccine project leader Wang Hui and her research team started racing the clock in a borrowed laboratory at the Chinese Center for Disease Control and Prevention.
On the morning of January 26, Dong Jianchun received a phone call from Wang, who asked him to convert an available room into a biosafety level 3 (BSL-3 or P3) laboratory. Another call came a few hours later. “Not a laboratory, but a production facility,” demanded Wang. “However hard it is, we need to build a workshop for inactivated vaccine production as quickly as possible.”
A workshop intended to produce an inactivated vaccine against a highly infectious disease like COVID-19 has to adhere to Good Manufacturing Practice (GMP) regulations to ensure pharmaceutical quality while meeting P3 standards. To complicate the situation further, domestic biosafety standards for a P3 facility to produce vaccines for human use had not yet been established by Chinese health authorities.
A P3 facility must be an independent building for biocontainment purposes. Fully equipped with electricity and water supply and drainage system as well as steam and compressed air systems, the company’s two-story workshop for culture medium was a viable option, but all production equipment in the building had to be removed first.
That evening, Wang reported the tricky situation to CNBG President Yang Xiaoming and asked for permission to make the next move. Dismantling the existing equipment to build a high-level biosafety vaccine production facility was a major decision. If vaccine development failed, an investment of more than a billion yuan (US$156 million) in the facility would be wasted.
“We have no option but to fight the virus,” Yang told top-level executives of Sinopharm, the parent company of CNBG. “The production facility must be built, and we have confidence in the research team.” Twenty-four hours later, the CNBG president gave the green light for dismantling.
Dong and his team immediately cut off power and water supply to the two-story building and threw themselves into the project. To save time, removal of old equipment and design of the new workshop were conducted simultaneously. “Workshop construction was not new to us,” said Dong. “The real challenge was building a plant that met the highest biosafety standards.” A detailed engineering plan was successfully devised thanks to concerted efforts from the design team, the construction team, and a risk assessment team.
When normal economic activities came to a halt in early February, it was difficult to find reliable suppliers of production equipment. Dong and his colleagues scrambled to contact qualified vendors to procure devices such as sterilizers, process tanks, isolators, and automated ventilation equipment customized to meet the highest standards. “We received an enthusiastic response from equipment suppliers when they realized what their products would be used for,” Dong recalled. “To ensure good quality and early delivery, many plant managers oversaw production personally.”
“All our equipment suppliers agreed to three conditions,” revealed Wang Hui. “First, their products had to meet international quality standards. Second, they needed to increase the number of shifts to produce around the clock to meet our demands for the sake of national interest. Third, they had to offer a fair price.”
A Race against Time
From elaborate preparation and planning to all-out mobilization of resources, effective coordination, and obtaining government approval, Dong and his team raced the clock to build a high-standard workshop.
Despite an early shortage of manpower, the project pressed ahead as more and more workers joined the team. At construction peak, more than 600 workers were working at the site.
On February 14, heavy snow fell on the construction site to welcome the workers. The project broke ground two days later on February 16, and equipment was secured by February 17.
“Concentrated efforts made it possible to complete such a high-standard workshop so fast,” said Dong. “The construction team’s duty was to create the conditions for mass production of the COVID-19 vaccine after it was successfully developed in the laboratory.”
In the stressful situation, Dong and his team were determined to complete construction of the core area in 60 days and the entire project in 75 days. As team leader, Dong spent most of his waking hours at the construction site. Consecutive night shifts and handling unexpected problems late at night became the norm. “I could only ever feel at ease when I was at the project site,” Dong admitted.
On March 30, the core area of the workshop was completed. On April 15, construction of the entire facility wrapped up. On May 30, a full and thorough disinfection was carried out. On June 13, the company obtained a manufacturing license from China’s National Medical Products Administration (NMPA).
On June 18, the General Biosafety Requirements for Vaccine Production Facility was issued by state authorities as emergency management policy in the fight against the COVID-19 pandemic.
On July 13, the facility of the BJIBP passed a joint biosafety inspection conducted by the National Health Commission (NHS), the Ministry of Science and Technology, and the NMPA. The inspection team concluded that the workshop was fit for large-scale production of a COVID-19 vaccine.
The BJIBP built the world’s largest inactivated COVID-19 vaccine production facility within a short period of just two months. The facility is capable of producing 3 million doses in a batch and achieving annual output of 120 million mass-produced doses. The first of its kind in the country, the workshop has played a significant role in helping combat the deadly disease.
“I felt relieved and happy to see the high-level vaccine production facility delivered on schedule, which was the result of highly-efficient joint operations across multiple parties,” Dong said.
Taking on responsibility when needed has become the motto of Wang Hui, BJIBP’s COVID-19 vaccine project leader. Under her leadership, Dong and his team not only completed the workshop at the highest standards, but also avoided any infections during the construction process.
Inspection on epidemic prevention and control work was conducted at the construction site twice a week by authorities. Workers in a single dorm room were reduced from six to eight people to two. A quarantine area was set up and thoroughly disinfected according to relevant requirements.
“We must ensure the health of all team members, especially while building a facility dedicated to vaccine production,” said Dong. “A single confirmed case would have shut down the entire project.”
On August 23, Dong and his team started building a second production facility with the same construction standards but six times larger. Again, they invested even more sleepless nights into the completion of the larger project.
By Wang Fengjuan