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End-to-End CGT CDMO Solutions — From Discovery to Commercialization

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
Cell line/template development					N/A
Process development & optimization
Analytical method development & validation
GMP manufacturing & release testing
Stability studies
Regulatory & CMC documentation support

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

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.

Sourcing & inventory management for raw materials and consumables (including pre-certified and in-stock materials)
GMP-compliant storage and cold-chain logistic support
Regulatory documentation support for IND/BLA submissions (CMC modules)
Cell bank and plasmid bank establishment and storage
Global registration support for projects in the U.S., EU, and Asia

Case Studies

Item	Catalog #	Product Name	Titer	Size	Price (USD)	Standard Timeline
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