.webp "Plasmids CDMO Solution")
As the genetic starting point for most cell and gene therapy products, plasmids are critical. Leveraging its GMP platform for nucleic acid therapeutics, Hillgene specializes in high-copy-number seed bank construction, high-density fermentation process development, and high-resolution purification methods. Our IND-level plasmid production system strictly follows GMP standards, yielding clinical-grade plasmids directly applicable for investigator-initiated trials (IIT) and IND submissions.
| CDMO Services for Plasmids | ||||
| Types | Services | |||
| IND grade | 1 | Independently Developed Four-Plasmid System | ● Third generation four-plasmid system ● KanR ● Granting the license, if required | ● Following standards for submission in both China and US ● Full-GMP workshop ● Separate area for creating cell banks ● Separate workshops within non-sterile and sterile areas ● GMP quality management system |
| 2 | GMP Creation of Bacterial Cell Bank | ● Selection of monoclonal antibodies ● Tailorable number of cell banks to be created ● Cell bank stability study | ||
| 3 | Process and Test Method Development | ● Following project requirements (subject to customized changes) | ||
| 4 | GMP Manufacturing of Plasmids | ● Production output: 10 mg~1 g (subject to customized changes) ● Fermentation volume: 3~30 L (subject to customized changes) ● Purification method: three-step approach/two-step approach | ||
| 5 | Plasmid Testing | ● Purity (HPLC) ● Residual E.coli DNA testing ● Residual E.coli HCP testing ● Residual E.coli RNA testing ● Residual antibiotics testing ● Sterility ● Mycoplasma ● Endotoxin | ||
| 6 | Method Validation | ● Specificity ● Accuracy ● Precision ● Linearity and Range ● LOD | ||
| 7 | Stability Study | ● Long-term stability ● Accelerated stability ● Stress testing | ||
*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services.
Advantages of our plasmid system:
• An independently developed four-plasmid system with KanR
• A system with the capability of sustained optimization
• Plasmid sequences are traceable, compliant with requirements, and efficient
• Extensive experience in successful IND submissions
• TCR-T cell samples for clinical use are currently manufacturing and in use
• 2-5 folds higher titers after using our plasmid system from the comparison in several projects
Advantages of our plasmid manufacturing:
• Free of antibiotics throughout the manufacturing process
• Plasmid production and bank creation in separate workshops
• Complete isolation between non-sterile and sterile areas
• Dispensing final products using an isolator
• Completed CTD dossiers for packaging plasmid (for lentiviral vector), reducing the submission preparation time by 3-4 months, with INDs of a few products granted preliminary approval and currently in phase I of clinical study
| Test Item | Test Method | |
| Appearance | Visual inspection | |
| Identification | Identification 1 | Restriction mapping |
| Identification 2 | Sanger sequencing | |
| Test | pH | Method 0631 of ChP 2020 |
| Purity | High performance liquid chromatography (HPLC) | |
| Residual E.coli host cell protein | ELISA | |
| Residual E.coli DNA | q-PCR | |
| Residual E.coli RNA | q-PCR | |
Residual antibiotics | ELISA | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Sterility | Method 1101 of ChP 2020 | |
| Concentration determination | DNA concentration | Method 0401 of ChP 2020 |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.
As your project advances to pivotal clinical stages, we scale up and optimize processes to ensure the supply of large-volume, highly consistent plasmid materials for global multi-center Phase II/III trials. We focus on inter-batch quality stability and reproducibility, implementing stricter release standards to guarantee medication safety and supply continuity throughout long-term clinical studies, thereby providing solid data support for market approval.
| CDMO Services for Plasmids | ||||
| Types | Services | |||
| Clinical grade | 1 | GMP Manufacturing of Plasmids | ● Production output: 10 mg~1 g (subject to customized changes) ● Fermentation volume: 3~30 L (subject to customized changes) ● Purification method: three-step approach/two-step approach | ● Full-GMP workshop ● Separate workshops within non-sterile and sterile areas ● GMP quality management system ● Validated plant, facility and equipment compliant with clinical requirements |
| 2 | Technology Transfer | ● Technology transfer ● Receiving technology transfer | ● Well-established plan for technology transfer ● Well-established plan for receiving technology transfer ● Plan for transferring of different technologies across different phases | |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
Advantages of our plasmid system:
• An independently developed four-plasmid system
• A system with the capability of sustained optimization
• Plasmid sequences are traceable, compliant with requirements, and efficient
• Extensive experience in successful IND submissions
• TCR-T cell samples for clinical use are currently manufacturing and in use
• 2-5 folds higher titers after using our plasmid system from the comparison in several projects
Advantages of our plasmid manufacturing:
• Free of antibiotics throughout the manufacturing process
• Plasmid production and bank creation in separate workshops
• Complete isolation between non-sterile and sterile areas
• Dispensing final products using an isolator
• Completed CTD dossiers for packaging plasmid (for lentiviral vector), reducing the submission preparation time by 3-4 months, with INDs of a few products granted preliminary approval and currently in phase I of clinical study
| Test Item | Test Method | |
| Appearance | Visual inspection | |
| Identification | Identification 1 | Restriction mapping |
| Identification 2 | Sanger sequencing | |
| Test | pH | Method 0631 of ChP 2020 |
| Purity | High performance liquid chromatography (HPLC) | |
| Residual E.coli host cell protein | ELISA | |
| Residual E.coli DNA | q-PCR | |
| Residual E.coli RNA | q-PCR | |
Residual antibiotics | ELISA | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Sterility | Method 1101 of ChP 2020 | |
| Concentration determination | DNA concentration | Method 0401 of ChP 2020 |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.
| CDMO Services for Plasmids | ||||
| Types | Services | |||
| Commercial grade | 1 | GMP Manufacturing of Plasmids | ● Production output: 10 mg~1 g (subject to customized changes) ● Fermentation volume: 3~30 L (subject to customized changes) ● Purification method: three-step approach/two-step approach | / |
*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services.
Advantages of our plasmid system:
• An independently developed four-plasmid system
• A system with the capability of sustained optimization
• Plasmid sequences are traceable, compliant with requirements, and efficient
• Extensive experience in successful IND submissions
• TCR-T cell samples for clinical use are currently manufacturing and in use
• 2-5 folds higher titers after using our plasmid system from the comparison in several projects
Advantages of our plasmid manufacturing:
• Free of antibiotics throughout the manufacturing process
• Plasmid production and bank creation in separate workshops
• Complete isolation between non-sterile and sterile areas
• Dispensing final products using an isolator
• Completed CTD dossiers for packaging plasmid (for lentiviral vector), reducing the submission preparation time by 3-4 months, with INDs of a few products granted preliminary approval and currently in phase I of clinical study
| Test Item | Test Method | |
| Appearance | Visual inspection | |
| Identification | Identification 1 | Restriction mapping |
| Identification 2 | Sanger sequencing | |
| Test | pH | Method 0631 of ChP 2020 |
| Purity | High performance liquid chromatography (HPLC) | |
| Residual E.coli host cell protein | ELISA | |
| Residual E.coli DNA | q-PCR | |
| Residual E.coli RNA | q-PCR | |
Residual antibiotics | ELISA | |
| Endotoxin | Method 1143 of ChP 2020 | |
| Sterility | Method 1101 of ChP 2020 | |
| Concentration determination | DNA concentration | Method 0401 of ChP 2020 |
*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items.
Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.
86 198 5711 6962 
info@hillgene.com 
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