Quality Grades

Comparison of our production processes and quality grades

PlasmidFactory offers clearly defined quality grades to support research, preclinical development, and clinical manufacturing. Our Scientific Quality Grade enables advanced research applications, High Quality Grade provides EMA-guidelines-based material for preclinical and early clinical programs, and GMP Grade supports late-stage clinical trials and commercial supply.

tabelle-cursor
Characteristics Scientific Quality (SQ) Grade

 High Quality (HQ) Grade*†

Plasmid | Minicircle

 GMP Grade

Plasmid | Minicircle
Research Grade Plasmid CCC Grade Plasmid | Minicircle
Produced by fermentation
Guaranteed amount of DNA
Adjustment of DNA concentration incl.
Customized filling included
Certificate of analysis (CoA)
Storage of glycerol stocks and retain samples for repeat orders
Antibiotic-free fermentation
Verified removal of bacterial endotoxins (LPS assay)
Removal of RNA and proteins
Removal of bacterial chromosomal DNA and oc-forms
DNA in ccc-form (≥95% supercoiled)
CGE analysis (ccc-supercoiled vs. oc-plasmid topologies)
Extended specification
Enzyme- and animal-free workflow   |   |   |
Characterized and documented cell bank and pilot cultivation
Documentation according to GMP/GMP principles
Dedicated lab
QM system applied
Spatially separated upstream and downstream processes
Single use equipment for the entire process
Compliant with applicable GMP-guidelines

* HQ: High Quality Grade  is produced in accordance with EMA guideline CHMP/BWP/2458/03 as the highest non-GMP quality standard
† Also available as “HQ in GMP“ Grade using an end-to-end single use process in dedicated GMP building

ccc: covalently closed circle
CGE: Capillary Gel Electrophoresis
LPS: Lipopolysaccharide
oc: open circular

Our quality grades

Scalable plasmid and Minicircle DNA — from research to clinical manufacturing.

PlasmidFactory offers clearly defined quality grades to support every stage of your project — ensuring regulatory alignment, performance consistency, and seamless scale-up within one trusted CDMO.

Scientific Quality (SQ) Grade

Advanced research standard

  • Research Grade – reliable DNA for routine and advanced laboratory applications
  • CCC Grade – ≥95% supercoiled DNA for performance-critical and topology-sensitive workflows

High Quality (HQ) Grade

Highest non-GMP standard

  • EMA guideline-based manufacturing with validated methods and full traceability
  • Ideal for preclinical and early clinical starting material
  • Also available as HQ in GMP: produced in dedicated GMP facility using end-to-end single-use processes

GMP Grade

Clinical & commercial compliance

  • Manufactured in a dedicated EU GMP (Annex 1 & 2) compliant facility
  • End-to-end single-use USP & DSP processes and in-house QP release
  • Various fill & finish options
  • Designed for late-stage clinical trials and commercial supply

EMA Guidelines

European Medicines Agency

The term “High Quality” is consistent with the meaning embodied in EM(E)A document CHMP/BWP/2458/03 (“Guideline on Development and Manufacturing of Lentiviral Vectors”); EMA document EMA/CAT/80183/2014 (“Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products”); and EMA document EMA/246400/2021 (“Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs”). PlasmidFactory seeks to ensure maximum safety and the highest quality DNA, although the plasmid production itself is not aligned to GMP standards.

CHMP/BWP/2458/03

Guideline on Development and Manufacture of Lentiviral vector (europa.eu)

EMA/CAT/80183/2014

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (europa.eu)

EMA/246400/2021

Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs (europa.eu)