Flexible production: meeting the growing
demands of the biotechnology sector.
BIOTECH PIONEER BAVARIAN NORDIC RELIES ON NEW ISOLATOR FILLING LINE FROM SYNTEGON TECHNOLOGY
Vaccines for human viral diseases are among the most successful inventions in medical history.
New vaccines employing biotech innovations are changing the way we prevent illness. However,they also lead to a number of challenges in research and development, scale-up and safety requirements. Moreover, they must be cost-effective and ensure a fast time to market. As a result,the biotech company Bavarian Nordic relied on state-of-the-art technology and expertise from
Syntegon Technology for its new isolator filling line for freeze-dried and liquid vaccine serums.
Biotech researchers are pursuing new vac-and to process our liquid products,” explainscines to prevent illnesses such as HPV,Bo Seligmann, Director Production Support

hepatitis-B and encephalitis. Improvements

at Bavarian Nordic. “On the other hand, wein research, manufacturing, and delivery

also wanted the new line to generally enhan-mechanisms are facilitating their work world-

ce our capacities for contract filling services.”wide. More people than ever now enjoy faster

After evaluating all possible options, Bavari-access to more effective vaccines against

an Nordic decided to purchase all the compo-

a broader spectrum of infectious diseases.

nents for the filling line from a single source,

There is a variety of new challenges in thisand ultimately chose a completely integrated

area: vaccines must be developed, produced,

solution from Syntegon Technology (formerlyand delivered with a short time to market,

Bosch Packaging Technology). “Because ofwhile process costs must be kept down wi-the complex requirements for this project,

thout compromising patient and employee

we wanted all machines and processes to besafety.

synchronized as smoothly as possible,” says
Bo Seligmann. “Syntegon’s line competence

COMPREHENSIVE FILLING LINE EXPER-

was exactly what we needed.”

TISE

Bavarian Nordic is a fully integrated biotechnology company
based in Denmark, Germany,
Switzerland and North Carolina, USA, focusing on the development, manufacturing andcommercialization of life-saving
vaccines.

In view of its ongoing growth, biotechnology

OUTPUT AND SAFETY COMBINED

pioneer Bavarian Nordic decided to expand

The company selected a vial isolator fil-its production capabilities and built a newling line from Syntegon with an integrated

production facility at its site in Kvistgård,third-party freeze dryer. The highly complex

Denmark.

isolator line combines nine machines andcomplies with GMO/biosafety level 2, the“Our main goal for this investment was totypical level for production plants that work

create a processing line to freeze-dry activewith live attenuated vaccines. The line’s core

substances in order to extend their shelf life,

is the filling machine MLF 5088CS, which

“Syntegon know their machines
best and they did the work very
efficiently. To finalize this project
within such a short time period
was only possible thanks to theprofessional collaboration between the experienced Bavarian
Nordic project team, the Syntegon
team and the third-party freeze
drier supplier. The cooperation
with Syntegon was a first for us.
Based on this experience, I canrecommend carrying out such projects in cooperation with Syntegon
Technology.”

combines a high output rate of 400 vials per

the rapid processing of the sensitive liquid

minute with optimal safety standards andingredients is crucial. “This means the newwith an integrated 100% in-process control

machines need to work quickly and absolu-(IPC). The filling machine is equipped with

tely reliably,” Bo Seligmann explains. The

the patented single-use dosing system Pre-

active virus serums are delivered in a frozen

VAS, which reduces the need for complicatedform, defrosted to roughly five degrees andcleaning procedures and minimizes the riskthen filled. They are kept cool throughout theof cross-contamination. The entire systemfilling process, other wise the integrity of theis completely contained in the isolator line,

active substance could be compromised. By

avoiding operator exposure to products.

reducing the humidity inside the isolator, theSyntegon experts made it possible to fill cold

Following filling and capping, the vials areproduct (2 - 8°C).

transferred to an RAN outside washer forexternal cleaning. This ensures that no sub-A FIRST AND HIGHLY SUCCESSFUL CO -stance particles adhere to the outer sides ofOPERATIONthe vials; an important factor in protecting

The complex line was delivered to the Bava-

the operator and healthcare workers fromrian Nordic site in Kvistgård in August 2019,the live viruses. The fast H₂O₂ airlock ISS

and Operational Qualification testing was fi-Bo Seligmann

ensures the fast and contamination-freenalized seven months later in February 2020.

Director Production Support at Bavari-transfer of goods into and out of the isolator.

“Syntegon Technology was very committed toan Nordic

As stand-alone machine, it can be bio-decon-the defined schedule, and the collaboration

taminated regardless of the current isolator

was very constructive,” says Bo Seligmann.

status. Moreover, the isolator line is decont-“It was very beneficial to have a thoroughaminated twice: the first time as the standard

design phase where we discussed the layoutprocess before production start, and once

and the requirements. In fact, subsequent

more immediately after wards to inactivatechanges amounted to less than one percent.

any product residue that might still be in theThat is a remarkable achievement that saves

line.

time and money.”

TWO PROCESSES AT ONCE – FOR MORE
EFFICIENT PRODUCTION

AUTHOR AND CONTACT:“For us at Bavarian Nordic, it was importantMatthias Angelmaier

to use reliable and proven standard machi-

Product Manager Barrier Systems

nes to ensure high product quality”, says Bo

E-MailMatthias.Angelmaier@syntegon.com

Seligmann. In addition, the line had to be asPhone+49 (7951) 402-7944

compact as possible to reduce facility footprint, and as flexible as possible to fill a wide
variety of vial formats. The machines support
fast format changes. As a further highlight,
the layout of the line enables Bavarian Nordic

Syntegon Technology GmbHto perform different processes simultaneous-Blaufelder Straße 45ly. Since the freeze-drying process can take

74564 Crailsheim, Germany

several days to complete, this allows Bavarian Nordic to use the line efficiently for paral-Phone+49 7951 402-0

lel filling of liquid products in the meantime.

E-Mailpackaging-ph@syntegon.com

Efficiency is also relevant in terms of time.

Websyntegon.com

Since Bavarian Nordic processes live viruses,