Every story has its silent heroes, and so does the fight against Covid-19: while big pharma and biotech start-ups have been in the spotlight for a while, Alice is working in the background to help drug producers provide the required vaccines. She is several feet long and fills Covid-19 vaccines into vials at Aspen Pharmacare.
Aspen is considered the most important pharmaceutical manufacturer in Africa, employing around 10,000 employees in 50 countries. Alice is based in Gqeberha, South Africa, where Aspen runs a new small-volume parenteral production facility. Besides Alice, Gqeberha is also home to Alf and Ted, two further filling lines from Syntegon. Naming the lines is more than a quirk of Aspen’s engineers: it helps staff tell the lines apart, as they serve different purposes. Ted fills terminally sterilized anesthetics into vials and cartridges in different sizes. Alf is an isolator line for ampoules based on the ALF 5000 filling and closing platform.
Filling vaccines for Johnson & Johnson
Alice is the first fully integrated isolator line in Aspen’s new SVP production facility. It features a washer and a depyrogenation tunnel and performs high-speed capping under open RABS with laminar flow. Alice is also based on the ALF platform with a combi filling station and isolator. When Johnson & Johnson knocked on Aspen’s door in 2021, “we immediately sensed this would enable us to move into vaccine filling and have a leg up on competition,” says Brendon Kriel, project engineer at Aspen.
Alice was willing to help and so were the service experts from Syntegon: within less than six months, Aspen was able to reliably mass-manufacture vaccines. The major challenge consisted in adapting the line to Johnson & Johnson’s Janssen vaccine, which is typically marketed in glass vials with a specific filling volume and container size. This made it necessary to install new format parts for container transport and filling. However, it was not technology alone that contributed to Aspen’s latest success.
Support from the embedded engineer
Depending on requirements, Syntegon sends a so-called embedded engineer with the right know-how from one of the regional service hubs to the customer’s site. Aspen had already used this service for the initial start-up phase for Alice – and booked it again in early 2021 for the changeover to vaccine filling. “This service is ideal during start-up when things can get a little bit complicated,” Ryan Miltz, application specialist for filling technologies at Aspen, says. “We know the process side, and which result we are expecting; but we definitely need support for the technical refinements.”
“We had a very tight schedule, which we absolutely had to meet to secure this new job,” Brendon Kriel adds. “The dedicated technical support allows us to quickly discuss issues and possible solutions on site. Our process engineers and operators save precious time and can fully focus on their core activities. Moreover, the transition from testing and qualification to production is speeded up significantly.”
The next sibling: Maxine
Today, Alice is running filling operations for the Janssen vaccine 24/7. And Alice, Ted, and Alf will soon welcome a new member to the family. Maxine will strengthen the new CMO vaccine filling operations in Gqeberha. “The simplicity, flexibility and ease-of-use of the Syntegon lines, together with an excellent level of customer engagement have convinced us to order our fourth SVP fill-finish line,” Ryan Miltz confirms.