Plasmid DNA
Plasmid DNA is a critical starting material for advanced therapeutics, such as viral vector-mediated cell and gene therapies. To support your therapeutic programs, Catalent offers extensive expertise in the bioproduction of plasmid DNA, from early stages of development to CGMP manufacturing to satisfy clinical and commercial needs. To streamline the transition of programs from pre-clinical to clinical development, Catalent has implemented the UpTempo℠ plasmid platform process. This optimized process, which also includes platform analytics, enhances the integration of plasmid capabilities with viral vector services, enabling Catalent to deliver optimized timelines while ensuring a secure and comprehensive end-to-end supply chain.
CATALENT’S FULL RANGE OF PLASMID SERVICES
LEAD DEVELOPMENT
- Best-in-class offering of off-the-shelf viral vector plasmids
- E. coli cell line development
- R&D-grade plasmid
UPTEMPO℠ PLASMID PLATFORM PROCESS
- Best-in-class offering of off-the-shelf viral vector plasmids
- E. coli cell line development
- R&D-grade plasmid
CLINICAL AND COMMERCIAL MANUFACTURING
- GMP E. coli Master and Working Cell Banking
- GMP and HQ grade plasmid production mg to g quantities
- Qualified analytical assays for plasmid release and cell bank characterization
- Full transparency, including access to GMP documentation
Integration of plasmid and viral vector/mRNA production at Catalent ensures optimized timelines and a secured supply chain.
THE RIGHT PLASMID QUALITY FOR DEVELOPMENT, THE CLINIC & BEYOND
Catalent provides plasmids in three distinct quality grades to meet your pre-clinical (R&D and HQ Select™), clinical (HQ Select™ and CGMP) & commercial (CGMP) requirements.
Operations
| Plasmid DNA Quality Grades | R&D | *HQ Select™ | cGMP |
|---|---|---|---|
| Manufacturing scale | |||
| GMP raw materials | |||
| Controlled environment (GMP suites) | |||
| Single-use process & qualified equipment | |||
| GMP Master and Working Cell Banking | |||
| Customized Master Batch Record |
QC
| Plasmid DNA Quality Grades | R&D | *HQ Select™ | cGMP |
|---|---|---|---|
| Critical Quality Attributes testing | |||
| Certificate of Analysis | |||
| Standard testing and specifications | |||
| Customized testing and specifications |
QA
| Plasmid DNA Quality Grades | R&D | *HQ Select™ | cGMP |
|---|---|---|---|
| TSE-BSE free certificate | |||
| Focused QA oversight | |||
| Full QA oversight and release | |||
| Customized Quality Agreement | |||
| Standard Quality Agreement | |||
| Client Deviation, OOS & Change Control oversight | |||
| GMP statement issuance by QP | |||
| Access to Production Documentation |
* Meets EMA GMP principles guideline
BENEFITS OF CATALENT’S PLASMID SOLUTIONS INCLUDE:
- Catalogue of best-in-class off-the-shelf AAV and LVV plasmids
- E. coli cell line development and GMP Cell Banking expertise
- Robust high-yielding UpTempo℠ plasmid platform streamlines the development phase and accelerates the pathway to the clinic and patients
- Integrated end-to-end supply CGT chain with UpTempo℠ GMP plasmid platform integrated into Catalent’s viral vector services
- In-house analytical platform assays
- Full transparency, including access to GMP documentation
- Service offering and plasmid quality grades to support your programs from development phase up to commercial applications
