Plasmid DNA
Plasmid DNA development and manufacturing for viral vector and mRNA production
Applications
Plasmids can be used as ancillary or critical starting material for:
- AAV or lentiviral vector manufacturing
- mRNA manufacturing
- Clinical manufacturing of biological drugs
Facility and Production
- Manufacturing Site: covering pDNA manufacturing (from R&D to cGMP), purification, and analytics
- Classification: The facility is classified as Grade D under Eudralex vol.4 Annex 1 (ISO 8), with filling performed under Grade A laminar flow hood (ISO 5)
- Production Scale: Flexible cGMP production scales ranging from 5L to 200L, with capabilities to produce quantities from 1 mg to over 10 g and possibility to adjust the batch sizes according to client needs
1. Microbial Cell Banking
2. Microbial Cell Culture
3. Cell Lysis (RNAse Free)
4. Purification
5. TFF/Formulation
6. Final Filling
Features
| Features | R&D | HQ | GMP |
|---|---|---|---|
| Quality Assurance overview and review of the final documentation | ✓ | ✓ | |
| Full traceability of materials | ✓ | ✓ | |
| Manufacturing ISO 9001:2015 quality standards in badge-controlled areas | ✓ | ||
| Manufacturing in segregated and dedicated clean room areas (grade D according to Annex 1 EU vol. 4 GMP) and fill and finish under grade A laminar hood according to Annex 1 EU vol. 4 GMP | ✓ | ✓ | |
| TSE-BSE statement | ✓ | ✓ | |
| Datasheet | ✓ | ||
| Certificate of Analysis | ✓ | ✓ | |
| Summary of the batch record | ✓ | ✓ | |
| Retention samples for 1 year | ✓ | ✓ | |
| GMP declaration | ✓ | ||
| Support in reviewing the documentation for regulatory purposes | ✓ | ||
| Issue review and approval of Client-specific Master Batch Production Record (MBPR) | ✓ | ||
| One audit for up to two people | ✓ | ||
| Particles and microbial monitoring during the filling process | ✓ | ||
| Copy of filled Batch Production Record (BPR) | ✓ | ||
| Description of the analytical methods (summary) | ✓ | ||
| Access to the analytical method qualifications (summary) | ✓ |
Quality and Regulatory Compliance
- Production and analysis are performed in ISO certified laboratories
- Most relevant features of cGMP manufacturing are applied (e.g., traceability, document control and materials segregation)
- All the equipment for production and analysis are validated (IQ/OQ protocols)
- All the starting materials and single use components are certified as TSE-BSE free
- Analytical assays are performed in-house
- The company has experience in supporting global IND submissions for gene therapy indications, having manufactured plasmid constructs for clients over the past decade
Client Services
- Project Support: Anemocyte provides comprehensive support from pre-clinical phases and clinical trials (phases I-III) to commercial needs
- Master Cell Banks: Expertise in establishing cGMP Master Cell Banks (MCBs) to support consistent and streamlined batch production
- Storage and Stability Studies: Offers storage options at various temperatures, with monitored and controlled environments. These can be coupled with stability studies to check plasmids over time according to client needs
Who We Are: Company overview
- Anemocyte is an Italian company specializing in plasmid DNA (pDNA) and mRNA research, development, manufacturing, and analytics
- Anemocyte has more than 20 years of development and manufacturing experience (from R&D to cGMP) in the field of Cell and Gene Therapies and Nucleic Acids
- The company operates a manufacturing site in Gerenzano, Italy (located on the outskirts of Milan)
Anemocyte is a proud member of
