Different quality levels of pDNA 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 manufacturing services for several quality grades – all available in large scale – tailored to your specific requirements (from basic applications in molecular biology to clinical development of advanced therapies).
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 for clinical applications.
We prioritize your research goals and look forward to providing you with the optimized solutions and manufacturing processes you need.
As the cell and gene therapy market grows, the demand for reliable plasmid DNA manufacturing services continues to rise. PlasmidFactory supports biopharmaceutical companies with optimized solutions for the production of pDNA, designed to meet the stringent needs of therapeutic CGT products, gene editing, and protein production. Our advanced production platform enables scalable production of high-quality DNA and DNA vectors, while ensuring precise control over production and quality. A critical step in production of DNA is the ability to efficiently purify plasmids and separate plasmid isoforms from host cell proteins, contributing to the functionality of the gene of interest and overall gene function. We also support the production of viral vectors and messenger RNA, offering tailored processes for CDMOs seeking improved production workflows. By addressing the bottleneck of the genetic medicine pipeline, we help drive the genetic medicine revolution, enabling innovation from early development to large-scale manufacturing.
Various quality grades of plasmid DNA to suit your specific needs.
Plasmid and minicircle DNA:
Level up
Plasmid and minicircle DNA:
Level up
Research grade
Research grade minimum order quantity 5 mg
- Plasmid and minicircle DNA in reproducible and certified quality grades
- Produced bio technologically in proprietary host cells:
- 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
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 minimum order quantity 10 mg
- Plasmid DNA in ccc-form (≥ 95% supercoiled)
- Reliable separation of impurities via chromatography (e.g., bacterial chromosomal DNA, genomic DNA and damaged pDNA)
- CGE analysis included
- All raw materials in accordance with EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate)
- Enzyme-free plasmid manufacture, from fermentation to lysis and pDNA purification
- QC report
Optimized DNA quality for various applications, such as basic research and preclinical and toxicology studies: high level of purification ensures highly reproducible and efficient co-transfection or AAV production
High Quality grade
- High-quality pDNA manufacturing, based on CCC grade production process
- CGE analysis included
- Compliant with EMA-guidelines CHMP/BWP/2458/03, CPMP/BWP/3088/99 and EMA/246400/2021
- QM system applied
- Proprietary process development
- Complete traceability with corresponding documentation of all production stages
- Dedicated production space
- Spatially separated, streamlined upstream and downstream processes
- Final sterile filtration available on request
- Quality control report
- Various production scales available due to a variety of bioreactors
High-quality plasmid DNA as starting material for GMP production of AAVs, CAR-T cells, mRNA vaccines and DNA vaccines
GMP grade
- Developed using HQ plasmid DNA manufacturing process
- GMP plasmids compliant with applicable GMP guidelines and GMP-certified
- Scalable pDNA production process
- Single use equipment throughout the whole production and purification process
- QC report
GMP plasmid DNA manufacturing of highest quality for late clinical phase and market supply for direct human application e.g., as therapeutics or in CGT
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Insights on plasmid production and purification processes
Comparison of our production processes and 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 for a wide range of applications, e.g., for clinical trials with CAR-T cells and RNA.
*HQ: High Quality Grade is produced in accordance with EMA guideline CHMP/BWP/2458/03 as the highest non-GMP quality standard **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) |
EMA Guidelines
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.
POLYARESCUE®
Keeping polyAs intact - a manufacturing service
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 for best results in mRNA production.
- Maintenance of long (> 120A) polyA stretches in plasmids
- DNA template for efficiently manufacturing mRNA
- Homogenous product
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.
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Get in touch so we can assist you in a targeted manner — either by filling out this online form or emailing us at:
contact@PlasmidFactory.com
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
- Other topic
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
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