Syntegon installs the world’s fastest filling line for IDT Biologika

Syntegon und IDT Biologika installierten die schnellste moderne Abfülllinie der Welt mit 100-prozentiger In-Prozess-Kontrolle. / Syntegon and IDT Biologika installed the fastest state-of-the-art filling line in the world with 100 percent in-process control

Als Teil der zusätzlichen Inline-Inspektion überwachen und dokumentieren integrierte Kameras und Sensoren jeden Prozessschritt. / As part of the additional inline inspection, integrated cameras and sensors monitor and document every process step.

To have additional filling capacity available quickly, contract manufacturers such as IDT Biologika need lines that are ready to produce large batches in the shortest possible time. IDT's latest investment shows how this is done: together with Syntegon, the company installed one of the fastest state-of-the-art filling lines in the world. It achieves a capacity of 80 to 100 million 2R vials per year and batch sizes of up to 500,000 containers – including 100 percent in-process control.

The demand for vaccines, viral vectors, and other biologics is rising continuously. Contract Development and Manufacturing Organizations (CDMOs) that have the necessary infrastructure for all relevant biosafety levels and are proficient in handling live viruses are in high demand. This also applies to IDT Biologika: The vaccines that the company has developed in collaboration with pharmaceutical companies over the past decades protect people against infectious diseases such as tuberculosis, AIDS, malaria, dengue fever, and Ebola. IDT also took on an important role during the Covid-19 pandemic by producing vaccines for AstraZeneca and Janssen on short notice.

The company had, however, recognized the growing capacity need much earlier. Even before the pandemic, the contract manufacturer was planning extensive investments to expand production at its headquarters in Dessau-Roßlau, Germany. When IDT Biologika was looking for a new, state-of-the-art line for the aseptic filling of commercial products, the company made speed the top priority. In addition, the fill-finish line needed to process large volumes and offer maximum flexibility with various filling systems.

SAT three weeks ahead of schedule

In June 2020, IDT awarded the contract to Syntegon. ”We received an ideal design concept for a complete line from a single source, including an isolator within our desired time frame," says Axel Goertler, head of strategic engineering and process design at IDT Biologika. ”With the new line, we wanted to fill our customers’ products even more flexibly, faster and to an even higher quality standard.” To master this complex task, a core team of five interdisciplinary experts from Syntegon laid the foundation for the successful construction of the filling line.

The SAT was successfully completed in less than 18 months – three weeks ahead of schedule. ”In times of Covid-19 and supply bottlenecks, professional project management was more crucial than ever. The key to success was direct and transparent communication,” says Steffen Grune, senior engineer at IDT Biologika.

Fast, flexible, and safe

The filling line itself matches the speed that both project partners initially envisioned. With a filling capacity of 80 to 100 million 2R vials per year and batch sizes of up to 500,000 containers, it is one of the fastest filling lines in the world, amongst other things thanks to its double magazine with precise piece count. The line also delivers in terms of flexibility. Thanks to several filling systems and format sizes from two to ten milliliters, it can process a wide variety of products.

Syntegon’s proven isolator technology provides the best possible separation of the operating and process areas. “We decided to run an H2O2 cycle not only before but also after filling,“ says Goertler. In addition, the previously cleaned vials are sterilized and depyrogenated using dry heat.

The highest quality through inline inspection

IDT even goes beyond the prescribed minimum standards for quality assurance. The optional empty vial inspection takes place right at the beginning of the process. Cameras check the integrity of the containers before filling and examine the vials for contamination through foreign bodies. Defective vials are automatically ejected by the system. ”With our very high processing speed of up to 600 vials per minute, we need this additional inspection process to avoid losing expensive active ingredient,” Goertler adds.

A 100 percent in-process control (IPC) makes sure that each of the previously approved vials contains the exact amount of active ingredient by weighing each vial before and after filling. An additional print is applied with UV ink and verified by means of a camera during crimping. A special containment system ensures maximum operator protection during printing and print counterchecking. In addition, integrated cameras and sensors monitor and document every step of the process; network cameras provide the necessary documentation if required.

An investment with foresight

IDT Biologika sees itself in an excellent position for the future. ”Our new high-speed line enables us to respond quickly to demands and expand our manufacturing capabilities,” says Grune. The option of retrofitting the line with two freeze dryers is also a far-sighted investment. IDT has already installed the appropriate pure media systems.

The vial cleaning machine is supplied with WFI and pure steam via a pure media system from the Syntegon subsidiary Pharmatec. The WFI loop, which is already connected to the cleaning machine, can also supply the two potential freeze dryers. ”Studies show that lyophilizates will play an increasingly important role in the future. Freeze-dried pharmaceuticals offer advantages in storage and shelf life and are used exactly when they are needed. This can be a decisive advantage, especially for vaccines needed at short notice,” Grune concludes.