Ramping Up Manufacturing to Help Address COVID-19
As the number of confirmed COVID-19 cases increased in Asia and began to spread to other regions around the world, a team of employees at Gilead’s manufacturing site in La Verne, California met in the early morning of Monday, Feb. 3.
The topic of the meeting: How quickly could the site begin to formulate, fill, package and ship Gilead’s investigational COVID-19 treatment, remdesivir?
“From that moment on, it was all hands on deck,” says Charlie Langdon, Senior Director of Manufacturing in La Verne. “It wasn’t just one department – this was literally our entire site coming together and strategizing about what needed to be done to make this happen as quickly as possible.”
Just eight days later on Tuesday, Feb. 11, the La Verne site was filling its first vials of remdesivir to support clinical studies and emergency use protocols for patients in critical condition with few options. The team began a six-week campaign to fill up to 25,000 vials of the investigational COVID-19 treatment every other day, while at the same time packaging and shipping vials of the drug received from external manufacturing partners.
Remdesivir is an investigational drug that has not been approved by any regulatory authority, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known. However, the drug supply is urgently needed to support multiple ongoing clinical trials, as well as expanded access programs created in consultation with regulatory authorities worldwide.
Gilead opened the La Verne site in 2017 with state-of-the-art equipment and automation – which along with the team’s experience building out and running the facility was helpful in preparing the site to quickly pivot to remdesivir manufacturing, says Richard Aman, Senior Director of the Project Management Office in La Verne.
“The biggest thing was that we didn’t try to divide and conquer – instead we had every department involved in making the decisions,” says Richard. “Every single person at our site is playing a critical role in this effort.”
Rubber stoppers are placed on newly filled vials of Gilead’s investigational COVID-19 treatment, remdesivir.
Still, there were challenges to overcome – new batch sizes of the drug product, new documentation requirements for the highly regulated process and a new manual inspection process that involves carefully inspecting each vial one-by-one.
“The most challenging part was getting started, but ever since we got up and running and did the first batch, we haven’t stopped,” says Huy Pham, Associate Director of Technical Services in La Verne.
To keep employees safe, the leadership team at La Verne has implemented physical distancing practices and worked to ensure that only people who need to be present to directly support manufacturing are on site.
Team members say they are inspired by the opportunity to play a role in potentially addressing this significant public health crisis.
“We all feel privileged and proud to be part of manufacturing this treatment that we hope can make a difference in the fight against COVID-19,” says Danielle Torres, Associate Director of Quality Assurance in La Verne. “With that also comes a great sense of responsibility, here in La Verne and at all levels of the organization. We can feel the potential magnitude of what we’re working on.”
Employees in La Verne inspect vials of remdesivir one-by-one.
