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Plasmid DNA

Integrated Solutions for Plasmid DNA Development & Manufacturing

Plasmid DNA ImagePlasmid DNA (also known as pDNA) is a critical starting material for advanced therapeutics including mRNA and viral vector-based cell & gene therapies. To support your therapeutic programs, the Catalent team has broad expertise in plasmid DNA engineering and manufacturing, from lead development to large-scale cGMP plasmid production for late-stage clinical and commercial needs.

Lead Development
  • Strain and clone selection
  • R&D-grade Plasmid
  • Proprietary mRNA vector backbone
  • Custom Capsid cloning services into AAV RepCap
  • Custom gene construct Cloning into GOI backbone
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Platform Offering
  • Scalable & Robust Platform for AAV Plasmids
  • Linearized plasmid Platform for mRNA IVT
  • Platform Analytics for Plasmid and Cell Bank
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On-Demand Development
  • Extensive experience in Microbial Process development
  • Linearized process optimization for mRNA
  • Analytical assay development
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Clinical & Commercial Manufacturing
  • GMP E.coli cell banking for MCB and WCB
  • HQ grade production (GMP principles) mg to g quantities
  • GMP grade Plasmid Production mg to g
  • QC Qualified assays for Plasmid Release and for Cell Bank Characterization

Integration of plasmid and viral vector/mRNA production at Catalent ensures optimized timelines and a secured supply chain

Off-the-Shelf Plasmids

Catalent now offers a range of proprietary off-the-shelf plasmids to speed up cell and gene therapy clinical programs. These include the 3 plasmid system consisting of the pHelper, RepCap, and a Gene of Interest plasmid for AAV viral vector production. While these are well supported for use with Catalent’s own clonal HEK-293 production cell line, and Catalent’s UpTempo℠ Platform, they have also demonstrated similar high performance with other cell-lines and production processes.

The Right Quality for the Clinic & Beyond

Catalent offers plasmids across three quality grades to meet your pre-clinical, clinical, and commercial needs for your customized plasmids.

Operations

Plasmid DNA Manufacturing OptionR&DHQ Select™cGMP
Manufacturing scaleUp to 30LUp to 300LUp to 300L
cGMP raw materials
X
X
Controlled environment
X
X
Qualified equipment
X
X
Single-use fermentation process
X
X
Single-use downstream process
X
X
cGMP Master and/or working cell bank(s)
X
X
Customized Master Batch Record
X

QC

Plasmid DNA Manufacturing OptionR&DHQ Select™cGMP
Critical Quality Attributes testing
X
X
X
Certificate of Analysis
X
X
X
Standard testing and specifications
X
Customized testing and specifications
X

QA

Plasmid DNA Manufacturing OptionR&DHQ Select™cGMP
TSE-BSE free certificate
X
X
Focussed QA oversight
X
Full QA oversight and release
X
Customized Quality Agreement
X
Standard Quality Agreement
X
Client involved Deviation, OOS & Change Control
X
cGMP statement issuance by QA
X
Customized documents and availability
X

Integrated Solutions for Advanced Therapeutics

With global facilities and clinical through commercial-scale production capabilities, our team is ready to help define and deliver an integrated program from the development of the optimal plasmid and its manufacturing process to seamless transfer into mRNA or viral vector production, including fill/finish and clinical supply services.