Cytovance

Plasmid DNA

Plasmid DNA 

As Plasmid DNA (pDNA) plays a critical role in the delivery of gene therapies into the targeted cells, the development and delivery of high-quality pDNA vectors are in high demand. Cytovance® Biologics recognizes this need from our clients, and with over 15 years of experience working with products of varying biological sources and complexities, we offer an Integrated Platform for pDNA manufacture. Cytovance Biologics provides you flexibility with its three differentiated offerings from our Oklahoma, OK, USA facility.

R&D Grade

• Plasmid is manufactured in R&D laboratories
• 30L scale fermentation, DSP sublots at approximately ~1 g pDNA, purified, per subplot, performed in non-CGMP R&D labs
• Documentation is appropriate for GLP Tox
• Executed batch records and certificate issued by Analytical Development
• All AD instrumentation is calibrated, qualified, and maintained per SOPs
• All batch documentation is reviewed and signed by R&D Quality team

Cytograde™

• Plasmid is manufactured in a CGMP qualified area using validated process equipment
• Process Batch Records are in draft and not issued or reviewed by QA
• Same process as R&D but performed in controlled clean rooms (CGMP)
• Documentation is more extensive with Tech Transfer documents, material specifications, CGMP draft Batch Records, and certificate from AD but not fully CGMP-compliant
• QA oversight includes equipment, facilities and personnel (not pDNA process)
• QA does NOT review batch records.  Instead, R&D Quality team reviews and releases executed Batch Records along with a certificate
• Investigation and CAPA processes not initiated by process deviations
• Ad hoc investigations can be performed by R&D or re-runs, depending on the extent of the deviations