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
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

Hyperhelix
percentage

EtBr staining gel
electrophoresis

Super spiral ratio ≥ 80%

Identify

Restrictive endonuclease digestion

Agarose electrophoresis

Meet the target strip

Target gene sequence
check

Sanger sequencing

Conforming to sequence

Security

Sterile

Cultivation method

Aseptic growth

Mycoplasma

QPCR

Negative

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

Tel:0531-58629111

PostCode:cdmo@lishanbio.com

Address:No. 4577 Jingshi Road, Lixia District, Jinan City, Shandong Province

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