Demand for high-quality good manufacturing practice (GMP) plasmid DNA has grown significantly in the past few years. The recent proliferation of mRNA manufacturing, DNA vaccines, viral vector production, CAR T-cell therapies, and CRISPR gene editing technologies have all contributed to a bottleneck in availability of plasmid manufacturing capability.
With decades of collective plasmid DNA manufacturing experience, the staff at Wacker Biotech US have released over 100 GMP batches encompassing more than 10 different products for both governmental and commercial clients. Over the years, a platform plasmid manufacturing process has been developed that is rapid, scalable, and customizable. Here, we introduce this process that can be tailored to meet the unique yield, quality, and regulatory needs of customers. Wacker Biotech US also offers in-house quality control (QC) and on-site quality assurance (QA) oversight to expedite testing and release.
Plasmid Manufacturing with Wacker Key Takeaways:
- Highly scalable platform pDNA manufacturing process
- Several yield, quality, and regulatory options available
- Comprehensive services for plasmid manufacturing, testing, and release
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