Research Grade
Research grade plasmid DNA and endonucleases to meet the needs of emerging biotechs & research-stage programs
We manufacture our research grade plasmids and endonucleases leveraging equipment and processes scalable to GMP. Our facility allows us the flexibility to offer small to large scale RUO production at speed, meeting the needs of emerging biotechs & research-stage programs.
Details:
- Robust process optimization to achieve desired critical quality attributes while maximizing yield
- Monitored critical process parameters (temperatures, times, agitation rates, etc.)
- Transformation, strain selection, clone selection, and growth conditions optimization (shake flask & Ambr250®)
- 2 x 5 L fermenters for production
- Chromatographic purification optimization (ÄKTA™ Explorer & Avant)
- Research cell bank generation
- Product characterization and QC release testing
- Research grade report
• Viability determination (Cell Titer)
• Cell bank purity (Plating on TSA and SDA)
• Host species identity (16S rDNA sequencing)
• Detection of lytic bacteriophage (COA)*
• Detection of lysogenic bacteriophage (COA)*
*Out-sourced
• Appearance (USP <790>)
• Purity Ratio (A260/A280 by UV spectrophotometry)
• Concentration (USP <857>)
• Restriction digest (Fragment analysis by restriction enzyme mapping)
• % DNA Supercoiled (Densitometry)
• Plasmid Identity (Size by Agrose gel electrophoresis)
• Plasmid Sequencing* (Sanger Sequencing)
• Mycoplasma* (RT-PCR)
*Out-sourced
• Viability determination (Cell Titer)
• Cell bank purity (Plating on TSA and SDA)
• Host species identity (16S rDNA sequencing)
• Detection of lytic bacteriophage (COA)*
• Detection of lysogenic bacteriophage (COA)*
*Out-sourced
• Appearance (USP <630>)
• Concentration (USP <857>)
• Identity (Western Blot)
• Purity
• Aggregation
• Activity, in vitro