The CDMO partner for next-gen medicine

As advanced therapies move from R&D to clinical trials and commercialization, developers increasingly need a contract development and manufacturing organization (CDMO) that can provide integrated expertise across nucleic acids, formulation technologies, analytics, process development, and GMP production. Wacker Biotech has strategically built exactly this combination of capabilities with an end-to-end manufacturing platform spanning plasmid DNA (pDNA), RNA, lipid nanoparticle (LNP) formulation and delivery, analytical development, and GMP manufacturing. This comprehensive approach allows customers to work with a single partner rather than coordinate multiple vendors across different stages of development and manufacturing, with the accompanying delays and transfer risks.

End-to-end nucleic acids

Unlike many companies that entered the nucleic acid space only after the success of COVID-19 mRNA vaccines, Wacker Biotech invested in RNA technologies and nucleic acid manufacturing well before the pandemic. In the last decade from facilities in Germany and the Netherlands, it produced clinical supply for two RNA candidates at the Phase III stage – a COVID-19 mRNA vaccine and an mRNA infectious disease vaccine. With the backing of parent company Wacker Chemie AG, it has continued investing in state-of-the-art RNA-based infrastructure, including building a dedicated RNA competence center in Halle, Germany that also serves as a critical pandemic preparedness partner for the German government. And it has expanded its capabilities beyond mRNA to circular RNA, self-amplifying RNA, siRNA, and other emerging RNA modalities.

Meanwhile, Wacker Biotech’s pDNA center of excellence in San Diego, USA has been producing plasmid DNA for more than two decades — and for multiple applications including direct applications like DNA vaccines and as starting material for RNA and viral vector (AAV- and lentivirus-based) medicines. It has produced 120+ GMP batches of pDNA using a diverse range of E. coli strains including a high-performing, proprietary E. coli strain that forms the basis of the industry-leading PLASMITEC^® platform. Given the importance of plasmid DNA as a template for RNA production, such long-standing expertise in plasmid manufacturing provides customers with a secure and reliable foundation for end-to-end development programs. Nucleic acid therapeutics and vaccines require tightly controlled production processes. By integrating these capabilities under one roof, Wacker Biotech reduces supply chain complexity, shortens project timelines, and minimizes technology transfer risks.

In 2026, Wacker Biotech strengthened this end-to-end offering even further with the launch of Contract Research Services from the WACKER R&D Biotechnology Center in Munich, Germany. R&D scientists at this facility can help customers optimize nucleic acid candidate molecules – for example through capping strategies and finetuning of nucleotide UTRs (untranslated regions) — while also cost-effectively producing very small quantities of pDNA and RNA at R&D grade. Because these R&D scientists work closely with colleagues at the manufacturing sites, they ensure that a nucleic acid construct is designed from the beginning with efficacy, safety, manufacturability, and scalability in mind.

Enabling the future of vaccines

The success of mRNA vaccines for COVID-19 and now their FDA approval in 2024 and 2026 for RSV and influenza, respectively, has demonstrated the efficacy of nucleic acid-based technologies. However, the future vaccine landscape will extend beyond infectious diseases. Personalized cancer vaccines, therapeutic vaccines, and next-generation prophylactic vaccines are expected to become increasingly important components of modern healthcare.

Wacker Biotech is ideally positioned at the center of this transformation. Its experience includes the production of pDNA and RNA as well as the formulation technologies required to deliver these molecules effectively. With 750+ GMP batches produced across all vaccine modalities, including two commercial products, the company supports both traditional vaccine developers and innovators pursuing entirely new paradigms. Wacker Biotech guides clients step-by-step through the complete vaccine development lifecycle.

More precision

Lipid nanoparticles have emerged as a leading platform for delivering nucleic acid medicines safely and efficiently. Wacker Biotech has therefore invested heavily in LNP formulation expertise and analytical methods as a core component of its advanced therapy offering.

A particularly exciting area is the development of targeted or decorated LNPs. While first-generation LNPs successfully deliver cargo to broad tissue populations, next-generation products increasingly require precise targeting to specific cell types or tissues. This is especially important for advanced therapies, where delivery efficiency can directly influence safety, efficacy, and dosing requirements.

And this is where Wacker Biotech’s even more extensive three decades of experience in microbial-based protein production and conjugation becomes another critical asset.

By attaching targeting ligands such as peptides, antibodies or antibody fragments, sugars, or other functional molecules to nanoparticle surfaces, Wacker Biotech can create decorated LNPs designed to enhance uptake by selected cell populations. Conjugation approaches can help improve biodistribution profiles, increase potency and safety, and enable entirely new classes of precision medicines. They can even prime T cells in vivo for the fight against cancer or other rogue cells. Such technologies provide a powerful platform for future RNA therapeutics, gene-editing applications, and targeted vaccines.

The regulatory landscape

Scientific excellence alone is not enough in advanced therapeutics. To gain the support of funders and regulatory authorities, developers must also navigate scale-up, regulatory expectations, supply reliability, and commercial manufacturing readiness. Wacker Biotech’s operational maturity in these areas for proteins, vaccines, nucleic acids, and conjugates provides customers with confidence that processes can be seamlessly scaled up into commercial manufacturing workflows.

A partner for tomorrow

The future of medicine will be shaped by advanced medicines capable of addressing disease at its genetic roots. From cell and gene therapies to RNA medicines, personalized vaccines, and targeted nucleic acid therapeutics, innovation is accelerating at an unprecedented pace. With its integrated capabilities, proven manufacturing expertise, dedicated infrastructure, and long-standing commitment to innovation, Wacker Biotech is uniquely positioned to help bring these breakthroughs to patients. Its end-to-end platform encompassing plasmid DNA, RNA production, and advanced LNP technologies, including opportunities for targeted and conjugated nanoparticle delivery, makes Wacker Biotech a compelling CDMO partner for companies seeking to transform scientific potential into clinical and commercial success.

Contact us:

info.biologics@wacker.com
www.wacker.com/biologics

This article is sponsored by Wacker Biotech.