Plasmid
DNA

Different quality levels for basic research up to (pre-) clinical studies

Discover tailored solutions with our pre-order consultations! We actively assess your needs for the perfect plasmid quality, ensuring a seamless match for your research. We offer several quality grades – all available in large scale – tailored to your specific requirements.

Our High-Quality grade plasmids are crafted for your benefit, particularly excelling in the GMP-compliant production of essentials like viral vectors, RNA or CAR-T cells.

We prioritize your research goals and look forward to providing you with the optimized solutions and manufacturing processes you need.

Various quality grades to suit your specific needs.

Plasmid and minicircle DNA:

Level up

Research grade

skip

Research grade  minimum order quantity 5 mg

  • Plasmid and minicircle DNA in reproducible and certified quality grades
  • Cultivation media used are in accordance with EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate)
  • Free of bacterial LPS endotoxins, RNA, and proteins
  • Quality control report
  • minimum order quantity 5 mg
Application

Alternative to Kits, for basic research suitable for all potential DNA applications (e.g., transfection, reference standard, antibody production)

CCC grade  minimum order quantity 10 mg

  • Plasmid DNA in ccc-form (≥ 95%)
  • Reliable separation of impurities (e.g. bacterial chromosomal DNA, damaged plasmids)
  • CGE analysis included
  • All raw materials in accordance with EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate)
  • Enzyme-free grade available on request (CCC grade classic)
  • Quality control report
Application

Optimized DNA quality for basic research and preclinical and toxicology studies: high level of purification ensures highly reproducible and efficient co-transfection or viral vector production

High Quality grade  

  • Based on CCC grade manufacturing process
  • CGE analysis included
  • Compliant with EMA-guidelines CHMP/BWP/2458/03, CPMP/BWP/3088/99 and EMA/246400/2021
  • QM system applied
  • Complete traceability with corresponding documentation of all production stages
  • Dedicated production space
  • Spatially separated upstream and downstream processes
  • Quality control report
Application

DNA as starting material for GMP production of AAVs, CAR-T cells, and mRNA vaccines

GMP grade  

  • Developed using HQ manufacturing process
  • Compliant with applicable GMP guidelines and GMP-certified
  • Single use equipment
  • Quality control report
Application

DNA of highest quality for late clinical phase and market supply for direct human application

Get in touch!

Insights

Comparison of our quality grades

We provide different quality levels for research and (pre-) clinical studies to ensure optimal adaption to your application. Our High Quality grade* plasmids are particularly suitable for GMP-compliant production of viral vectors and RNA, for example.

*HQ: High Quality Grade is produced in accordance with EMA guideline CHMP/BWP/2458/03 as the highest non-GMP quality standards **On request
Grades table as PDF
Research grade
CCC grade basic
CCC grade classic
High Quality grade*
GMP grade
Characteristics
Applications
Applications
Applications
Applications
Applications
Produced by fermentation
Guaranteed amount of plasmid DNA **
Adjustment of DNA concentration included
Customized filling included **
Certified quality incl. QC Report
Storage of glycerol stock and retain samples for repeat orders
Antibiotics-free fermentation
Cultivation media according to EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate)
All raw materials according to EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate)
Completely enzyme-free
Characterized and documented cell bank and pilot cultivation
Verified removal of bacterial endotoxins (LPS assay)
Removal of RNA and proteins
Specific removal of bacterial chromosomal DNA and oc-forms
CGE analysis (ccc-supercoiled vs. oc plasmid topologies)
Extended Specification **
Documentation according to GMP/GMP principles
Dedicated lab
QM system applied
Spatially separated upstream and downstream processes
Single use equipment
Compliant with applicable GMP-guidelines and GMP certified

EMA Guidelines

EMA Logo

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 manufacturing itself is not aligned to GMP standards.

CHMP/BWP/2458/03

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

Read guideline on europa.eu

EMA/CAT/80183/2014

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

Read guideline on 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)

Read guideline on europa.eu

POLYARESCUE®
Keeping polyAs intact

PlasmidFactory’s proprietary POLYARESCUE® technology can amplify plasmid DNA containing long polyA stretches. Our Next Generation Sequencing technology complements the optimized fermentation process, allowing sequencing and quantification of polyA sequences while maintaining intact plasmids.

  • Maintenance of long (> 120A) polyA stretches in plasmids
  • DNA template for efficient mRNA production
  • Homogenous product

Scaling up: We offer DNA products of the highest purity in greater quantities than ever.

Read our large-scale story

PlasmidFactory was the first industry to really believe in this (Minicircle) technology. […] They scaled it up and took risks. I think this is what good industry is about, to take risks in a technology you believe in.

Prof. Dr. Daniel Scherman, Member of European Academy of Sciences EURASC
1 / 2

Let us know how
we can help.

Get in touch, that way we can help you in a targeted manner.

I would like personalised advice on the following topic …

  • Manufacturing of customized plasmid DNA
  • Manufacturing of customized minicircle DNA
  • In-Stock products for AAV production
  • In-Stock products (reporter-plasmids/-minicircle)
  • cooperation opportunities

I would like a specific quote for the following product

  • Customized DNA
  • AAV plasmids und minicircles
  • reporter gene plasmids and minicircles
  • pEPito plasmids
  • Molecular Size Markers
  • CGE Service
  • Storage Service

Select
dialogue

provide required
information

receive
offer

Useful background information

The most important terms relating to minicircle DNA and plasmids explained in detail. Useful background information for smooth communication.

We are aware of our responsibility towards our fellow human beings and the environment. We act in accordance with general ESG (Environmental Social Governance) criteria.

ESG