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Plasmid Manufacturing

Catalent offers customized plasmid DNA services from milligram to gram scale with HQ Select™ and GMP Ultra™ grades for use as raw materials or APIs for your viral and non-viral applications. Our experienced team will help you identify which grade is suitable for your stage of clinical development 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 Options
HQ Select™
GMP Ultra™
Manufacturing scale
Up to 500L
Up to 500L
GMP raw materials
X
X
Controlled environment
X
X
Qualified equipment
X
X
Single-use fermentation process
X
X
Single-use downstream process
X
X
Manufacturing with Master Batch Record
X
GMP master and working cell banks
*
X
Critical quality attributes testing
X
X
QC specifications
X
X
OOS management
X
X
Certificate of Analysis
X
X
QA oversight
X
QA approved Master Batch Record
X
Deviation, change control
X
Quality agreement
X
Quality release
X
GMP statement issuance
X
TSE-BSE free certificate
X
X

* GMP master and working cell banks are recommended for high quality and are an option.

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