pDNA / mRNA / LNP
Wacker Biotech is your CDMO partner and resource for advanced therapies, including messenger RNA (mRNA), plasmid DNA (pDNA) and lipid nanoparticle formulations (LNP’s). A great team you can trust!
Our customers benefit from Wacker Biotech’s R&D and GMP solutions as a one-stop-shop for the development and GMP manufacturing of mRNA / pDNA at scales to meet your clinical and commercial needs.
During the Corona pandemic, Wacker Biotech jump-started mRNA manufacturing in Amsterdam, The Netherlands, with large-scale production capabilities for mRNA process transfers, and is now one of the few CDMOs with hands-on GMP manufacturing experience of mRNA-based therapies up to process validation. Now, we are taking this to the next level! In Halle, Germany, we are building a brand-new mRNA competence center with GMP capabilities for pDNA, mRNA and LNP manufacturing – all under one roof in the heart of Germany. The new plant is part of the German Pandemic Preparedness Initiative, but half of the capacity is available to customers from early clinical to commercial. The expansion will be completed by Q1/Q2 2024. Our development labs are already up and running to support technology transfers, process development or R&D supply. Wacker Biotech is part of a new synergistic network formed during the pandemic – one of these partners is CordenPharma. The nucleic acid experience of Wacker Biotech combined with the lipid expertise of CordenPharma ensures the best possible results for each of our customers’ mRNA projects.
WACKER's offering for meeting current pDNA market needs
Wacker Biotech’s center of excellence in San Diego, CA, provides fermentation-derived pDNA at various scales and quality levels. We serve our customers who develop pDNA-based drugs or use pDNA as a critical starting material for advanced therapies, such as viral vectors and mRNA. Fermentation, downstream purification, including continuous lysis, and pDNA quality control are part of our proprietary PLASMITEC® platform. A highly experienced, specialized team provides products and services that meet the highest quality and compliance standards.
The production site in San Diego is equipped with 43 L single-use bioreactors and 650 L stainless-steel fermentation vessels, including continuous cell lysis. Corresponding primary recovery and downstream capabilities are available to suit various customer needs along the manufacturing path. Our team is highly experienced and has been manufacturing GMP-compliant pDNA since 2003 (more than 100 GMP batches released).
We want to be more than ‘just’ a CDMO, we want to contribute with cost-saving production technologies and process innovations! Wacker Biotech’s mRNA production services are supported by years of experience in designing efficient and tailored solutions for our customers. Our dedicated nucleic acid R&D unit is focused on continuously improving and advancing all aspects of our technology, capabilities and understanding of pDNA, mRNA, LNP formulations and related analytics.
Wacker Biotech offers a variety of development services to our customers including:
- A proprietary pDNA ->mRNA ->LNP platform process
- Basic development of new processes and technologies in state-of-the-art laboratories with new equipment
- Strain development for pDNA manufacturing
- New plasmid designs
- Improved mRNA manufacturing processes fully aligned with our GMP capabilities
- LNP formulation development
- New formulation methods
- Quality control of nucleic acids / formulated particles (including cell culture assays)
- Manufacturing of R&D material to support customers during ‘proof of concept’ phase
- Short lead times and quick project turnaround
Alternatively, and based on our proven experience in transferring mRNA-based production processes, we can bring your process to our facilities, with or without process optimizations.
For mRNA GMP production, click here.Wacker Biotech and CordenPharma’s development partnership in the field of LNP formulation combines the nucleic acid expertise of Wacker Biotech with the lipid expertise of CordenPharma.
Our customers will benefit from our ability to offer a broad spectrum of LNP formulations for their mRNA-based product as an integral part of the mRNA manufacturing process performed at Wacker Biotech’s mRNA competence center in Halle, Germany.
- R&D collaboration with CordenPharma and academia to advance LNP formulation and manufacturing
- Fill & finish and supply of LNP raw materials by our partner CordenPharma