Personalized cancer vaccines activate potent, antigen-specific T-cell immunity by targeting patient-unique tumor neoantigens, offering a paradigm shift beyond conventional therapies. Among various modalities, mRNA-based PCVs are advancing rapidly due to their intrinsic advantages in development speed, manufacturing simplicity, and scalability.
Enorna has built an integrated platform for end-to-end PCV production—from neoantigen design and mRNA synthesis to LNP formulation. Our streamlined process enables timely, cost-effective, and targeted manufacturing of patient-specific vaccines, accelerating clinical translation to bring the promise of precision immunotherapy to more patients.
The primary challenges in mRNA personalized cancer vaccine (PCV) manufacturing lie in the requirements for small-scale production, rapid turnaround, cost containment, and rigorous quality assurance.
Enorna has built dedicated infrastructure, equipment, and workflows specifically for PCV production. Our platform integrates tailored processes and rigorous quality controls to deliver high-quality, patient-specific vaccines with shortened timelines and optimized costs.
Plasmid-mRNA-LNP Process Development
Analytical Development
Regulatory Support
•Equipment (e.g., TFF, encapsulation) is configured for small-batch, patient-specific production.
•Minimize dead volume and maximize product yield by integrating small-volume tubing systems.
•Optimized PCV-specific processes ensure low loss, high yield, and consistent high quality.
•Tailored quality control strategies enables fast lot release and rapid patient dosing.
•Dedicated facility for PCV GMP manufacturing.
•Chain of Identity (COI) and Chain of Custody (COC) for end-to-end traceability of individualized products, preventing any mix-ups or batch errors.
•Single-use consumables and tubing to eliminate the risk of cross-contamination.
•Complete validation documentation, fully compliant with GMP requirements and supporting audit trails.
Plasmid Production
Plasmid Linearization
mRNA IVT
LNP Encapsulation
Release Test
Streamlined and optimized E. coli fermentation to significantly shorten timeline while ensuring full regulatory compliance.
Linearization efficiency >95%, effectively minimizing residues.
100% single-use resins and tubing systems to eliminate cross-contamination.
Customized TFF equipment designed specifically for small-scale PCV production, featuring low dead volume and minimal material loss.
Custom microfluidic encapsulation systems for small-scale batches, characterized by low dead volume and high recovery rates.
Real-time, millisecond-level flow rate control achieved through proprietary algorithms.
Consistent results with particle size ≤100nm, PDI <0.2, and encapsulation efficiency (EE%) >95%.
Reach Out Today
Contact us
Tel. +86 18961517608
E-mail. bd@enorna.com
Address.
63 Keji Avenue,
Bldg. 6, Fl. 6,
Yixing, Jiangsu, China
