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Our Services
End-to-End CGT CDMO Solutions — From Discovery to Commercialization
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OranssiBio provides fully integrated, standardized, and regulatory-compliant CDMO services across the entire development lifecycle of cell and gene therapies. Our offerings span five core technology platforms — plasmids, lentivirus, AAV, mRNA-LNP, and cell & exosome therapies — delivering flexible and scalable solutions tailored to each development stage. -
Our services are built not only on technical depth, but also on a strong commitment to GMP compliance, global certification, data traceability, product consistency, and stringent intellectual property protection, ensuring smooth clinical translation and successful commercial execution for novel therapeutics.
Service Scope
| Service Scope | AAV | LVV | Exosome | Cell | Plasmid | mRNA-LNP |
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| Cell line/template development |  |
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| Process development & optimization | |
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| Analytical method development & validation | |
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| GMP manufacturing & release testing | |
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| Stability studies | |
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| Regulatory & CMC documentation support | |
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Notes:
- All platforms support full-scale services from early-stage R&D to commercial manufacturing
- All services are conducted within GMP-compliant, traceable, and documentation-ready systems
- The mRNA-LNP platform supports both vaccine and therapeutic applications, based on a robust IVT and LNP formulation system
Deliverables
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GMP-Compliant Manufacturing
In full alignment with NMPA, FDA, EMA, and ICH standards — supporting clinical trial supply and commercial submissions. -
Globally Recognized Certifications
ISO 9001-certified quality system and GMP facilities that meet stringent inspection requirements. -
Comprehensive Data Traceability
End-to-end systems covering QC, process controls, and batch documentation — enabling reliable R&D and regulatory filings. -
Batch-to-Batch Consistency and Product Stability
Standardized SOPs ensure reproducibility and high-quality output across production runs. -
Robust IP Protection Framework
Comprehensive NDAs and strict safeguards for client data, results, and proprietary processes.
Customiza Services
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Sourcing & inventory management for raw materials and consumables (including pre-certified and in-stock materials)
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GMP-compliant storage and cold-chain logistic support
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Regulatory documentation support for IND/BLA submissions (CMC modules)
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Cell bank and plasmid bank establishment and storage
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Global registration support for projects in the U.S., EU, and Asia
Case Studies
| Item | Catalog # | Product Name | Titer | Size | Price (USD) | Standard Timeline |
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| LV | 200101 | LV-VSVG-GFP | >107 TU/ml | >30 /ul | 100-400 | 2-3 weeks |
| LV | 200102 | LV-BaEV-GFP | >107 TU/ml | >30 /ul | 100-400 | 2-3 weeks |
| Exosome | 300001 | Ex-HEK293 | >107 Particles/ml | >30 /ul | 100-400 | 2-3 weeks |
| Exosome | 300010 | Ex-IPSC(noonatal foreskin cell) | >107 Particles/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100001 | AAV1-Empty Capsids | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100002 | AAV2-Empty Capsids | >1012 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100005 | AAV5-Empty Capsids | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100006 | AAV6-Empty Capsids | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100008 | AAV8-Empty Capsids | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100009 | AAV9-Empty Capsids | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100101 | AAV1-GFP | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100102 | AAV2-GFP | >1012 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100105 | AAV5-GFP | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100106 | AAV6-GFP | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100108 | AAV8-GFP | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
| AAV | 100109 | AAV9-GFP | >1013 VP/ml | >30 /ul | 100-400 | 2-3 weeks |
