Plasmid CDMO service

Plasmids are small circular DNA molecules with self-replication function that can carry exogenous target genes into host cells for expression. Plasmids can be used as gene delivery vectors for constructing viral vectors, as well as end products for prophylactic or therapeutic drugs. With the rapid development of DNA vaccines and gene therapy technology, the demand for large-scale production of plasmid DNA continues to increase.

The Lishan Biotech Plasmid Production Platform adopts the QbD concept design, with an overall cleanliness standard of C+A. To meet the rapid development needs of cell gene therapy, it is equipped with world-class production lines and scalable GMP production processes. It can provide customers with one-stop GMP plasmid CDMO services from drug discovery to IIT, from IND to NDA, and then to commercial production.

Data download

Plasmid CDMO

Service content

Service category	service content
Plasmid construction	Customers provide plasmids or sequences to select advantageous strains and construct the original library.
Construction of strain library	Construct and verify the stability of MCB and WCB strain banks under GMP conditions.
Optimization of fermentation process development	Selection of culture medium, no animal origin, no antibiotic high-density fermentation, optimization of process parameters to determine key process parameters.
Optimization of purification process development	Research and optimization of cracking process parameters, ultrafiltration process parameters, chromatography process parameters.
Methodology development validation	Methodology validation: Establishing quality standards for specificity, accuracy, precision, detection limit, etc.
Stability study	Influence factor testing, accelerated stability, usage stability, and long-term stability

Production process

Process characteristics

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Quality Control

Classification detection items	Detection items	Method	Testing standards
Physical and chemical properties	Appearance	Visual inspection	Colorless Transparent Liquid
	pH	Potentiometric method	7.2±0.5
	Content	Spectrophotometer	1.0±0.2mg/ml
Purity	UV260/280 ratio	UV spectrophotometry	1.75-2.0
Purity	Hyperhelix percentage	EtBr staining gel electrophoresis	Super spiral ratio ≥ 80%
Identify	Restrictive endonuclease digestion	Agarose electrophoresis	Meet the target strip
Identify	Target gene sequence check	Sanger sequencing	Conforming to sequence
Security	Sterile	Cultivation method	Aseptic growth
	Mycoplasma	QPCR	Negative
	Mycoplasma	Cultivation	Negative
	Endotoxin	LAL detection	≤0.01EU/ug pDNA
Residual	Host RNA residue	SYBR Gold stained agarose gel electrophoresis	Undetectable by Ethidium Bromide stain(≤0.05ug/ugDNA)
	Host DNA residue	q-PCR	≤50ng/μg
	Host protein residue	ELISA	≤1ng/μg