Syntegon, formerly Bosch Packaging Technology, and bio pharmaceutical leader AbbVie set new standards in aseptic high-potent filling lines.
Antibody-drug conjugates (ADC) are amongst the most important pharmaceutical trends. More than 70 new therapies for oncological use were launched between 2013 and 2017. While they can help patients significantly, these drugs are also highly toxic. When it comes to planning and designing new filling lines, a reliable separation of operating staff and product is paramount. AbbVie, in cooperation with Syntegon, developed an aseptic filling line for liquids and lyophilizates that redefines standards for operator protection, while ensuring efficient production.
Compact hygienic design
Key elements of the new isolator line for AbbVie are a customized ALF filling platform and a VRK capping machine. “One of the highlights of the line is its hygienic design. We redesigned its key points completely, with focus on handling products up to OEB 6,” explains Matthias Angelmaier, product manager for isolator technology at Syntegon.
Syntegon and AbbVie also developed new wash down equipment and a unique step-by-step user guide that leads operators through the cleaning process. To reduce the risk of possible contamination due to filter leakage to a minimum, double HEPA filtration levels provide additional protection for the isolator plenum and the process air handling unit.
“For high-potent filling lines, flexible production without compromising user safety is a key requirement,” says Angelmaier. “The possibility to separate each of the four isolator segments (filling machine, lyo loading and unloading, capping) enables AbbVie to undertake different production steps on the same line at the same time.” The line comprises an optimized H2O2 decontamination cycle thanks to the Syntegon SafeVAP system in combination with dedicated catalytic H2O2 converters and adapted injection points. “These modifications reduce decontamination time and production downtime,” says Angelmaier. “Together we have developed a line that enables AbbVie to produce efficiently and in compliance with the highest safety standards.”