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Engage the Experts
pDNA, mRNA, and LNP Solutions from Research to Commercialization

Wacker Biotech is your CDMO partner for the entire manufacturing chain of plasmid DNA (pDNA) and messenger RNA (mRNA) to lipid nanoparticle (LNP) formulations. We leverage our global team of development, process engineering, and manufacturing experts and a network of state-of-the-art facilities to accelerate our partners’ programs from research phase to the market.

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You benefit from our decades of experience in complex protein-based therapeutics, vaccines, and specialty chemicals sectors, including partnering with the German government to respond to the Covid-19 pandemic.

We invite you to explore this page and discover Wacker Biotech’s end-to-end services, including pDNA, mRNA and LNP capabilities and insights from our scientific leadership.

PLASMITEC® – our proprietary pDNA production platform – executes fermentation and downstream purification, including continuous lysis and pDNA quality control to make pDNA manufacturing efficient and accessible without compromising quality.

Our highly experienced team has successfully developed and produced plasmids at our pDNA Center of Excellence in San Diego, California, USA, since 2003.

Learn more about our pDNA capabilities, and contact us to discuss your needs.

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Your benefits

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Quality tailored to application: Support for varying needs, including plasmids for research use, High Quality plasmids serving as a critical raw material for AAV, lentivirus, mRNA and cell and gene therapy, as well as GMP plasmids for injectable pDNA products at clinical and commercial scales.

Innovation: Ongoing new high-producer strain development, novel plasmid designs and innovative analytical methods.

Efficiency: Our PLASMITEC® pDNA product platform efficiently produces even the most complex plasmids and streamlines regulatory filings.

Scalability: All research- and pilot-scale production fully aligns with GMP production, enabling seamless scaling throughout your product's lifecycle.

Short Lead Times: Our extensive capacity, expert team, and highly efficient production platform shorten lead times and speed project turnaround.

Wacker Biotech has been a reliable all-in-one CDMO partner for decades. In Amsterdam, NL, we jump-started mRNA manufacturing during the COVID-19 pandemic, making us a leading CDMO with hands-on GMP manufacturing experience of mRNA-based therapies, including validation GMP runs. With the addition of another cutting-edge competence center for mRNA actives in Halle, Germany, we have increased our RNA product manufacturing and LNP formulation capacity. In this dynamic field of advanced therapies, you will benefit from experienced, reputable partners validated by the German government.

Our pDNA, mRNA and LNP capabilities allow us to be an end-to-end partner, reducing your project timelines and eliminating the risks associated with choosing multiple vendors.

We’re looking forward to discussing your mRNA contract manufacturing needs.

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Your benefits:

End-to-End Capabilities: Wacker Biotech’s pDNA, mRNA, and LNP development and manufacturing capabilities offer holistic mRNA therapy CDMO solutions.

Full Program Support: With Wacker Biotech, you have a seamless CDMO partner for the entire manufacturing chain for developing and GMP manufacturing of pDNA and mRNA, including LNP formulation, to meet your clinical and commercial needs.

Unmatched Experience: Our comprehensive development and manufacturing capabilities are backed by decades of experience in advanced therapies.

Unrivaled Quality: The German government validated our mRNA Center of Excellence in Halle, Germany, for their Pandemic Preparedness Initiative. This very same state-of-the-art facility is available to you.

Innovative Formulation Development: Industry-leading scientists and state-of-the-art facilities lead ongoing platform innovation.

LNP formulation expertise is important to Wacker Biotech's integrated nucleic acid expertise for a true end-to-end mRNA solution.

We’re looking forward to discussing your LNP contract manufacturing needs.

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Your benefits:

Supply Chain Reliability: Wacker Biotech is partnered with leaders in lipid production to provide reliable source of lipids to deliver true end-to-end mRNA therapeutics.

Innovative Formulation Development: You will have access to the latest nucleic acid technologies supported by WACKER’s central R&D in Munich, including continual formulation development, advanced analytics and production strategies.

Fit-for-Purpose: LNPs are outstanding payload delivery vehicles and can take a wide variety of forms to meet the needs of a specific program.

These capabilities can include the formulation of bulk drug substance, as well as aseptic filling in vials, stoppering, capping and visual inspection. Wacker Biotech offers liquid fills in 2R to 20R vials and lyophilization of up to 20,000 vials per batch, or to perform bulk lyophilization of up to 65 liter bulk drug substance.

Our aseptic filling suite consists of a formulation/preparation area, a filling area containing a Flexicon filling machine for filling, stoppering and capping, and an Edwards freeze drier (6 m2).

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Your benefits:

End-to-End Capabilities: Wacker Biotech’s pDNA, mRNA, LNP and fill & finish development and manufacturing capabilities offer holistic mRNA therapy CDMO solutions to meet your clinical and commercial needs.

Full Program Support: We have strong experience in formulation and lyophilization development and are ready to collaborate to develop your biopharmaceutical drug product.

Unmatched Experience: Our comprehensive development and manufacturing capabilities are backed by decades of experience in advanced therapies.

Flexibility: We tailor our services to your needs with flexible process design and rapid raw material supply.

Insights from Our Experts

Overcoming pDNA Supply Challenges for mRNA Manufacturing

Mack Kuo, Associate Director of Process Development, Wacker Biotech US, explores the skyrocketing demand for pDNA as mRNA and gene therapy candidates continue to progress from preclinical to early- and late-stage clinical studies. Learn how experts are navigating obstacles such as sourcing challenges, quality issues, scaling difficulties, and lack of standardization. Download the file from the box below.

Navigating mRNA Manufacturing with Flexibility and Innovation

Michael Van der Horst, Head of BioProcess Development, Wacker Biotech, shares how Wacker Biotech is meeting the challenge of the complex, multistep processes involved in mRNA–LNP manufacture. Gain insights into how true end-to-end CDMOs can help coordinate raw material supply, scaling, and aligning steps across vendors. Download the file from the box below.

Technology Advances Needed to Drive Future mRNA Growth

Hagen Richter, Head of Nucleic Acids Research, Wacker Biotech, discusses how applications for mRNA are evolving beyond vaccines to therapeutics that treat large populations and personalized therapies tailored to individual patients. Richter also explores the opportunity for innovation in mRNA therapeutic manufacturing, such as continuous strategies and alternatives to pDNA, in vitro transcription, and LNP delivery. Download the file from the box below.

Engage the Experts in Nucleic Acid Therapies

Founded in 1914, WACKER was a key player in forging specialty chemistry advancements throughout the 20th century. In the 21st century, Wacker Biotech has leveraged our wealth of resources, scale, and deep expertise to help advance tomorrow’s life-saving therapies. In close collaboration with universities and research institutions, WACKER’s corporate R&D team of over 200 researchers continuously develops new production platforms and technologies for all types of biopharmaceuticals, including pDNA, mRNA and LNPs. Competitive, outstanding solutions are our trademarks.

Powered by our network of global facilities and commitment to excellence, Wacker Biotech continues to advance nucleic acid therapies, proving highly effective for treating, curing, and preventing diseases for patients worldwide.

Take advantage of this opportunity to shape the future of mRNA therapeutics. Contact us, your reliable mRNA CDMO partner, today for your next mRNA project.

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Featured Wacker Biotech`s GMP-Certified Facilities

Contract manufacturing plant specializing in the formative production of pDNA and extensive process development services. It has 6 L through 43 L flex-scale single-use bioreactors and a 650 L stainless-steel fermentation vessel, including continuous cell lysis. Corresponding primary recovery and downstream capabilities are available to suit various customer needs.

While today, the San Diego site is primarily dedicated to pDNA development and production, this facility will also offer mRNA process development and analytical capabilities.

Our Halle facility is in the heart of one of Europe's leading life sciences hubs. Halle has years of experience and expertise with the production of recombinant proteins and is Wacker Biotech’s competence center for in-vitro protein refolding, supporting all other sites in development and optimization projects. The site collaborates with the Halle TGZ (technology and startup center) and the many universities, companies, and institutes that innovate at the Weinberg Campus in Halle.

The site is now extended by a dedicated high-end mRNA manufacturing facility in collaboration with the German government as part of the “National Pandemic Preparedness Program”. The plant comprises four independent process lines with high production volume and process design capabilities. In this, pDNA supply, mRNA drug substance, and LNP formulation are enabled by the multipurpose character of this facility. Designated specific capacity is independent and is always available as a full CDMO in the mRNA field by offering services and capacities to customers from early clinical to commercial projects.

Home to our mRNA Center of Excellence, the Amsterdam facility provides capabilities for developing mRNA-based processes and GMP manufacturing of customized mRNA processes.

The site is also a full-service contract manufacturer of biopharmaceutical proteins based on microbial systems and it provides GMP production and manufacturing of biopharmaceuticals, live biotherapeutic products and vaccines for innovative therapies that treat or prevent serious illnesses.

Our Jena plant is a contract manufacturing facility for recombinant proteins and pharmaceutical actives for clinical testing and the commercial market.

Related:
Contract Manufacturing Why WACKER

Better with WACKER

Let’s work together to advance your nucleic acid therapy.

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