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.
| 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 | 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 | 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 |
| 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 | EtBr staining gel | Super spiral ratio ≥ 80% | |
| Identify | Restrictive endonuclease digestion | Agarose electrophoresis | Meet the target strip |
| Target gene sequence | 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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