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Wacker Biotech new state-of-the-art mRNA competence center in Halle, Germany.

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The emerging field of mRNA therapeutics is still young. This class of therapeutics is poised to have broad implications in the treatment of many indications in addition to infectious diseases such as cancer, autoimmune diseases, and cardiovascular diseases, as well as regenerative medicine. Prior to the emergence of the COVID-19 pandemic, Wacker Biotech realized the vast potential of mRNA as a therapeutic and began investing in mRNA-specific technology and continues to devote resources to advance this field.

During the pandemic, the CDMO put its knowledge to work developing and manufacturing both COVID-19-related mRNA vaccines as well as non-COVID-19-related therapeutics.

Their new Halle-based mRNA competence center is a major next step and will more than triple the CDMO’s production capacity at this site. Designed to be agile, the mRNA competence center is not limited in scope to mRNA vaccines but can also address the development and manufacturing of an extended array of RNA therapeutics.

Trusted CDMO

“Wacker Biotech clients can be assured they will have access to the latest state-of-the-art processes and process platforms. Our high-end facility in Halle brings together our GMP competence for RNA product manufacturing and LNP formulation at scale,” said Sebastian Schuck, PhD, Senior Director, Client & Contract Management, Wacker Biotech.

Sebastian Schuck
Sebastian Schuck, PhD, Senior Director, Client & Contract Management, Wacker Biotech

“Wacker Biotech was selected by the German government as a stand-by producer of mRNA- based vaccines for its pandemic preparedness program. This means our clients also benefit from a high level of quality,” continued Schuck. “In Halle, we have the  capability to produce mRNA vaccines on a  large scale within a short timeframe.”

Wacker Biotech offers a broad spectrum of services, including small- to large-scale mRNA production from mg to kg within a few months, transfer of clients’ processes, development of customized processes, on-hand stock supply of pDNA starting material, and LNP formulation. In addition, its partnership with CordenPharma, a leading expert in the production of lipids for LNP formulation, brings additional delivery capabilities.

The CDMO’s established track record, internal end-to-end services, and history of technological innovations supporting the progression of the RNA field provide a solid foundation to effectively respond to clients’ needs. This includes scaling diverse types of processes, developing the analytical methods for process monitoring and product releases, and implementing custom or transferred processes in the GMP production environment.

Continually developing capabilities

Wacker Biotech continues to focus on expanding its agile mRNA capabilities to optimize efficiency and their ability to adapt to evolving regulatory requirements in the dynamic, evolving landscape of novel modalities, such as saRNA and long RNAs.

Proprietary platform processes are in place for both pDNA and mRNA. To avoid raw material shortages, standard unit operations are employed including standard filter setups, bags, and buffer preparations. In addition, small-scale, high-throughput screening capabilities enable thorough exploration of many different process parameters and thus provide greater process understanding at a reasonable cost.

The CDMO’s proactive approach to increasing and diversifying its capabilities through platform innovation and strain and formulation development, among other activities, affirms its dedication to innovation and excellence in the quest to provide patients needed medicines.

“The Halle facility has flexible scales suitable for early clinical to commercial supply,” detailed Schuck. “We can support virtual companies that have no supply chain as well as big pharma. We have supply chains in place and the capabilities to develop a process from the bottom up based on our state-of-the-art platform process or, alternatively, transfer an established process. Timelines for a typical project are 6–9 months from start to GMP manufacturing.”

Importantly, as a CDMO, Wacker Biotech is agnostic regarding indications and works tirelessly to ensure that innovative new therapeutics can be produced in the quantities required for clinical trials and commercialization.



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