GMP-Grade Plasmid Production

Creative Biogene offers GMP-grade plasmid production services that provide industrial users and pharmaceutical companies with large-scale plasmid preparation to help clients efficiently advance in cell transfection, DNA vaccines, antibody preparation, cell therapy, gene therapy and other preclinical research. Our scalable approach allows us to help our customers provide comprehensive solutions for the entire process of GMP-grade plasmid vector cloning, amplification, purification, and quality control analysis.

Our Services

Creative Biogene offers flexible GMP-grade plasmid production services. We meet our clients' project development demands through a diverse range of services, including but not limited to the following:

Accepting existing plasmids from clients for full scale plasmid production.
Reconstitute any existing plasmids by cloning the client's gene of interest into one of Creative Biogene's proprietary vector backbones using our advanced technology to bolster production capacity.
Complete upstream and downstream process development is provided to support the client's project process.

GMP Grade Plasmid Production Process

Creative Biogene offers a complete plasmid preparation platform, where plasmids undergo a multi-step purification process and stringent quality control testing to ensure the highest quality plasmid DNA is produced. Our GMP-grade plasmid production line, with strict control over the process and the final product, ensures that the final product quality meets customer requirements.

GMP-Grade Plasmid Production

Plasmid DNA Manufacturing Process Control

Plasmid design & construction
Research-grade screening & growth optimization
GMP master cell bank generation & qualification
Process development & methodology
GMP bulk plasmid manufacture

Seed expansion & cell collection
Cell lysis & cell debris removal
Plasmid DNA concentration & buffer exchange
Plasmid DNA isolation
Supercoiled plasmid DNA separation
Final sterile filtration

QC and batch release
Supporting documentation

QC Standards for Different Applications

QC Items	Description	Endo-free	Medical Grade	GMP Grade
Appearance	Clear, no visible particles	✓	✓	✓
Concentration	On request, 1μg/μl by default	✓	✓	✓
A260/280	1.8-2.0	✓	✓	✓
Supercoiled Content		Predominantly supercoiled	≥ 90%	> 80%
Residual Host RNA	Not visible by electrophoresis	✓	✓	< 5%
Residual Host gDNA	Not visible by electrophoresis	✓	✓	< 2%
Residual Host Protein		N/A	N/A	< 5%
Sequencing	Identical to client-supplied sequence or client-supplied reference material	✓	✓	✓
Restriction Analysis	Conforms to reference	✓	✓	✓
Bioburden Assay	No growth on agar plate after 48 hours	N/A	✓	✓
Endotoxin Test	For endo-free preps only	< 100 EU/mg	< 10 EU/mg	< 10 EU/mg

Service Features

Bacterial library generation.
Disposable fermentation (50 L-200 L).
Ultrafiltration and purification system.
Isolated production line to completely avoid cross contamination.
Strict quality control checks and standards.
Batch records, manufacturing summary reports, CoA.

What We Deliver

Deliverables	Quality control analysis and quality standards	Turnaround time
GMP grade plasmid	Appearance (transparent, no visible particles) Concentration (default 1mg/mL, concentration can be adjusted according to demand) Super spiral percentage (≥90%) Insert sequence consistency sequencing (absolutely correct) Restriction endonuclease analysis (Consistent with expected size) A260/280 (1.8-2.0) Residual RNA (gel electrophoresis not visible) Residual E.coli DNA (genomic DNA<15% of plasmid bands) Bioburden (48 hours no growth) Endotoxin content (endotoxin ≤ 0.01 EU/μg) TSE/BSE certificate	1-2 months

Creative Biogene offers fast, high throughput, high-quality and personalized GMP plasmid DNA preparation services to meet our customers' large scale plasmid production demands. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

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