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Plasmid Manufacturing

Catalent offers customized GMP plasmid DNA services from milligram to gram scale for use as raw materials or APIs for your viral and non-viral applications. Our experienced team will develop a manufacturing plan with the goal of providing a fully compliant CGMP process as your candidate progresses towards late stage studies and commercialization.  Our integrated manufacturing services for plasmid DNA, viral vectors, and cell therapies with seamless transitions and tech transfers provides our partners with a reliable, robust supply chain.  A partnership with Catalent for plasmid DNA and viral vector manufacturing facilitates a more streamlined process, with consistent quality and allows you to leverage our expertise in developing scalable, commercial-ready processes and our EMA and FDA approved commercial viral vector facility.  Catalent is committed to helping our partners get their advanced therapies to patients, faster.

Plasmid DNA Manufacturing Attributes
Manufacturing scale up to 500L
GMP raw materials
Controlled environment
Qualified equipment
Single-use fermentation process
Single-use downstream process
Manufacturing with Master Batch Record
GMP master and working cell banks
Critical quality attributes testing
QC specifications
OOS management
Certificate of Analysis
QA oversight
QA approved Master Batch Record
Deviation, change control
Quality agreement
Quality release
GMP statement issuance
TSE-BSE free certificate

R&D-grade plasmid production is available as part of our lead identification and development services.