01
Cell BankCell-Bank Construction
Tiered master and working cell banks under low-passage control ensure consistent, traceable sourcing.
Technology Platform
Technology Platform
From upstream cell banks to downstream release testing, Tonigen runs a full-process GMP exosome production and quality-control platform that delivers stable, traceable, and scalable raw-material supply for brands.
Process Pipeline
Six stages from upstream culture to batch release.
6 STAGES
UPSTREAM → RELEASE
UPSTREAM → RELEASE
02
CultureScaled Culture
Serum-free culture up to 8,000L with in-line monitoring enriches high-activity exosomes at scale.
03
TFF PurifyTFF Purification
Third-generation tangential-flow filtration strips host protein and free nucleic acid to 99.4% purity.
04
LyophilizeLyophilized Stabilization
Custom lyophilization curves and cryoprotectant systems preserve particle size and membrane activity.
05
FillingAseptic Filling
Grade-A aseptic filling inside the clean room supports injectable, lyophilized, and liquid formats.
06
ReleaseRelease Testing
Per-batch characterization with sterility and endotoxin testing, released only with COA and third-party reports.
Why Tonigen
Four capabilities set the new exosome raw-material standard.
EST. 2015
SHANGHAI · CHINA
GMP CLASS 10,000
SHANGHAI · CHINA
GMP CLASS 10,000
Ultra Purity
Ultra Purity
Particle distribution is concentrated around 30-150nm with CD9 / CD63 / CD81 positivity and HPLC purity >= 99%.
Custom Formula
Custom Formula
Supports loading, lyophilization, blends, and co-branded formulation from pilot batches to scaled production.
GMP Certified
Full-chain Certification
GMP clean-room manufacturing with ISO 13485 / CE / FDA Registered systems and batch-level COA package.
Scaled Capacity
Scaled Capacity
8,000L annual culture system capacity supports kilogram-level material supply and low-MOQ evaluation.
Characterization & QC
Full Characterization Package
Each batch is characterized around particle size, surface markers, purity, endotoxin, and sterility, with COA and third-party reports so customers can evaluate and onboard with confidence.
Get Quote →Compliance
Full-chain certification for long-term brand growth.
Quality and compliance systems span GMP / ISO 13485 / CE / FDA, with end-to-end traceability from raw material to delivery that lowers market-entry barriers for global customers.
Certifications
GMP Good Manufacturing Practice
ISO 13485 Medical device quality system
ISO 9001 Quality management system
CE EU conformity
FDA Registered
NMPA China filing
Ready to Collaborate
Ready to Elevate Your Product Line?
Share your application and MOQ requirements. Within 48 hours, you will receive a tailored quotation, COA package, and sample-shipping plan.