INDReady ™ Plasmid DNA

Our INDReady™ Program is designed to meet the requirements for cGMP intermediates.  INDReady™ Plasmid DNA is produced so that all processing components used are dedicated for single plasmid use or are disposable. All components used are animal free or are treated in compliance with appropriate regulations to reduce the risk of TSE/BSE contamination.  These contracts have a dedicated scientist and are processed in dedicated rooms.  The processing utilizes our proprietary resin, PolyFlo® (DMF13090) and results in highly pure DNA meeting the specifications detailed below. A Manufacturing Summary of all documentation can be provided and is suitable for IND submission.

Included

Custom Premium INDReady™ Plasmid DNA

PARAMETER SPECIFICATION
Appearance Clear, Colorless, No Visible Particulates
Sterile Fill Sterile Filled by Quality
A260:280 1.7-2.0
Concentration Amount Ordered (mg) / 10ml
DNA Homogeneity ≥90%
Residual RNA None Detected @ 1.0ug load
ssDNA, Linear DNA, Chromosomal DNA None Detected @ 1.0ug load
Protein Reported
pH of Final Product 7.5-8.5
Endotoxin <30 EU/mg
Identity Consistent with Provided Information for 2 Restriction Reactions
Five Day Bioburden No growth on plates
Bottling Collaborator Defined