Plasmid Solutions
Process
R&D Grade
GMP
Lite*
cGMP
Notes
Research Grade
1mg – 250mg
- Suitable for Discovery, Preclinical, and Toxicological studies
- Shake flask process using Plasmid DNA prep kits or Fermentation process with full DSP
- Adequate QC control
Gene Synthesis
Process Optimisation
Shake flask or Fermentation process
Full DSP process
Certificate of Testing
KLS helper plasmids:
MOQ: 1 mg
Turnaround time: Off shelf
Custom GOI plasmids:
MOQ: 1 mg
Turnaround time: 45 days
GMP Lite
10mg – 250mg
- Scalable, consistent quality and cost effective solution for early phase clinical trials
- Process, Materials and Consumables consistent with full GMP allowing seamless transition from later phases and commercial manufacturing
Cell Bank Generation
GMP grade RMs (free of animal origin) Qualified Vendors
Facility Control
1)segregated suites 2)full line clearance
Full GMP Spec QC testing
CoA
QA Oversight
Mfg Summary report
TSE / BSE certificate
Stability studies
KLS helper plasmids:
MOQ: 1 mg
Turnaround time: Off shelf
Custom GOI plasmids:
MOQ: 1 mg
Turnaround time: 45 days
Full GMP
10mg – multiple grams
- Full GMP as per global standards
- Scale optimized to suit client needs from early phase clinical trials t commercial
GMP classified production suites
Single use fully validated equipments
Environmental monitoring
Full GMP QMS system
Certificate of GMP compliance
KLS helper plasmids:
MOQ: 10 mg
Turnaround time: Off shelf
Custom GOI plasmids:
MOQ: 1 batch (~500–800mg)
Turnaround time: 100 days
