Utilizing WuXi Biologics platform technologies, our services are adaptable to provide pDNA at different grades:
Research (R&D) grade:
Our R&D grade production services are designed to produce material with a quick turn-around time with purity specifications customized per your needs for its intended use. We have streamlined our operations to provide the most cost-effective product.
High Quality (HQ) grade:
The production of high-quality (HQ) grade pDNA is leaner and less stringent when compared to true GMP manufacturing. Production is conducted via a phase-appropriate approach and customized to balance speed and cost considerations with fit-for-purpose quality requirements.
Our GMP-produced pDNA is manufactured following U.S. FDA, EMA and NMPA cGMP requirements. Beyond DS and DP manufacturing, our GMP services also include GMP Master Cell Bank (MCB) and Working Cell Bank (WCB) production, and testing and quality control laboratories located on-site.
WuXi Biologics Standard High Quality (HQ) and cGMP pDNA Production Platform
- Strains utilized produce pDNA suitable for nucleic acid gene therapy applications, mRNA template production (e.g., vaccines) as well as raw material supply for GMP viral vector or vaccine production
- Flexible manufacturing scale from 10 – 300 L fermenter
- Standard column purification process with robust recovery unit operations to deliver high-quality and low-impurity product
We provide comprehensive product and process development support for pDNA products. For more information on our full CMC development capabilities for microbial-derived products – go here.