Closing the circle on biologics manufacturing

Plasmid DNA (pDNA), the small circular genetic material discovered in bacteria as a method of horizontal gene transfer, has revolutionized biological production. Plasmids are a raw material or “building block” for biopharmaceutical manufacturing. Plasmids for specific products are available, such as circular plasmids for recombinant proteins, linear plasmids for mRNA, and proprietary plasmid backbones for viral vector expression. Both cellular and cell-free systems require bespoke and optimized plasmids as blueprints of synthesis to ensure product specificity. During the development and production scale-up, the demand for this blueprint also increases.

The availability of high-quality plasmid DNA throughout the workflow is essential for maintaining the yield, quality and reproducibility from the early development to the GMP (Good Manufacturing Practices) manufacturing stage. However, coordinating with a number of suppliers and tight deadlines while prioritizing the quality of raw materials makes scale-up difficult. Supply chain instabilities can delay the securing of high-quality raw materials like pDNA and gene fragments, prolonging development timelines. In the case of scaling up an in-house developed plasmid candidate, a company would have to focus on developing bespoke methods and conditions for master cell banking, purifications, and analytical and regulatory testing. The best way to navigate these pain points and accelerate scale-up is to partner with a Contract Development and Manufacturing Organization (CDMO) like Aldevron.

Aldevron’s plasmid DNA manufacturing services can provide plasmids spanning from RUO (Research Use Only) to cGMP manufacturing grades. Aldevron provides the full suite of services from plasmid manufacturing to release testing. Additionally, Aldevron offers master cell banking services, purification development, quality review, and analytical and regulatory testing from a single provider, ensuring a consistent supply of validated plasmid material.

Biopharmaceutical manufacturing relies on plasmids as a starting material for the synthesis of biologics. The scaling up to production demands a consistent supply of raw materials like plasmids throughout the workflow. Contact an expert at the Life Sciences companies of Danaher today to partner.