Our Story
Pfizer-Trained Quality, Applied to Synthetic Biology
Nanjing PathGene Biotech is an innovative enterprise focused on the R&D, manufacturing, and global delivery of high-purity bioactive ingredients through synthetic biology — providing innovative functional ingredients and biomanufacturing solutions to the global nutrition & health, functional food, pharmaceutical, and personal care industries.
12
Invention Patents
1,500㎡
Production Area
50+
Export Countries
Our Background
From Pfizer to PathGene
PathGene's founder worked as a Quality Engineer at Pfizer, deeply involved in building one of the world's most stringent pharmaceutical manufacturing quality systems. That experience revealed a persistent gap: raw material suppliers rarely operated at the quality standards demanded by finished-goods pharmaceutical manufacturers.
Built around three core competencies — AI enzyme engineering, synthetic biology, and industrial-scale manufacturing — PathGene has established an integrated technology platform covering enzyme design, strain development, fermentation optimization, downstream purification, and commercial production, enabling rapid translation from laboratory research to scalable manufacturing.
Today, our products are used by pharmaceutical companies, nutraceutical brands, and research institutions across 50+ countries. But our founding goal has never changed: every batch, every COA must withstand scrutiny from the world's most regulated markets.
Milestones
2025
Patents Granted & International Certifications
First 6 invention patents granted. ISO9001 certified. Products validated against USP/EP dual pharmacopeia.
2025
Global Export Launch
Products enter European, North American, and Southeast Asian markets with full regulatory compliance.
2025
12 Invention Patents
Patent portfolio covers full product line: NMN, NAD⁺, NR, CDP-Choline.
2025
Company Founded
December 2025: PathGene Biotech officially founded in Nanjing by a team from Pfizer and other leading pharma companies, focused on high-purity synthetic biology ingredients.
2025
First Production Line Commissioned
1,500m² clean facility completed. NMN enzymatic synthesis process passes third-party certification audit.
Mission & Values
Why We Never Compromise on Purity
In regulated markets, a 0.5% purity gap can mean an entire batch rejection. Our mission is to ensure no customer ever has to compromise on ingredient quality for any market.
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Science First
Every process decision is driven by science, not cost-cutting.
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Full Traceability
From raw material to finished product, every step is documented and traceable.
🤝
Partner Mindset
We don't sell ingredients — we partner with you through product development.
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Global Compliance
FDA, EMA, NMPA documentation support built into every engagement.
Our Facility
Jiangsu · 1,500m² Clean Facility
Our facility is located in Jiangsu Province, China, covering 1,500m² with clean rooms, a fermentation engineering center (50L–8,000L scale), an automated QC laboratory, and cold-chain storage systems.
All products undergo independent third-party laboratory testing. Full analytical data is available to every customer — our transparency is our strongest endorsement.
1,500 m²
Clean Production Area
50L–8,000L
Fermentation Scale
400 m²
Cold-Chain Storage
24H IoT
Real-Time Monitoring
100%
Batches Third-Party Tested
USP / EP
Dual Pharmacopeia
Cold-Chain Temperature Zones
R&D Capability
300m² Advanced Bioengineering Lab
PathGene's R&D center is equipped with multiple Agilent HPLC systems, automated digital polarimeters, micro-spectrophotometers, and comprehensive strain construction and gene editing equipment for rapid metabolic pathway optimization.
A parallel bioreactor cluster (1L–50L) supports process model development, ensuring R&D results can be directly scaled to industrial production and significantly shortening the cycle from lab to ton-scale output.
AI Enzyme Engineering Platform
Powered by proprietary AI algorithms and a massive high-quality sequence library, PathGene achieves rapid virtual screening of enzyme molecules, precisely identifying industrial enzymes with thermostable, alkaline-tolerant, and solvent-resistant properties — substantially cutting wet-lab trial-and-error costs while significantly improving chiral purity and catalytic efficiency.
1500+Enzyme Library Scale
A proprietary enzyme protein library spanning core categories — ketoreductases, glycosyltransferases, glycosidases, transaminases, and esterases — covering major reaction types including oxidoreduction, transfer, and hydrolysis, serving pharmaceutical, chemical, and food applications.
93GBSequence Data Assets
93GB of high-quality enzyme sequence data assets, continuously expanding — each dataset is deeply cleaned and functionally annotated, providing a solid foundation for AI training.
−80%Screening Cycle Reduction
R&D cycles compressed from years to months under the traditional approach — a closed-loop iteration from virtual screening to wet-lab validation accelerates the path from concept to pilot scale.
Digital R&D Advantage
A database of 93M+ non-redundant enzyme protein sequences underpins our "digital-first" R&D paradigm — from AI-driven initial screening and molecular dynamics simulation to laboratory-directed evolution, the entire process is traceable and explainable, with every decision grounded in data.
Quality Control
Quality Control
Three-tier quality gates spanning every step from raw material to finished product
Incoming Quality Control
The first checkpoint before raw materials and strains enter inventory — intercepting non-conforming materials at the source.
- Supplier qualification review and raw material traceability verification
- Identity confirmation for key raw materials (e.g. IR spectral comparison) and preliminary purity screening
- Non-conforming materials are quarantined and rejected from inventory
In-Process Quality Control
Real-time monitoring of key steps like fermentation and enzymatic catalysis — issues are caught during the process itself, not after the fact.
- 24-hour real-time monitoring and logging of key process parameters (pH, temperature, dissolved oxygen, conversion rate, etc.)
- Staged sampling of intermediates to track impurity profiles and reaction endpoints
- Quality control checkpoints between process steps — non-conforming intermediates do not proceed to the next stage
Outgoing Quality Control
The final checkpoint before every batch ships — full test data accompanies every shipment as a Certificate of Analysis.
- Full testing of HPLC purity, appearance, solubility, and moisture/loss on drying
- Heavy metal testing (lead, arsenic, mercury, cadmium) and microbial limits (total plate count, yeast/mold, E. coli, Salmonella)
- Each batch is independently verified by third-party laboratories, with a COA accompanying every shipment
Our Quality Assurance Approach
- Three-tier IQC–IPQC–OQC gating intercepts issues at each stage before they carry forward
- Full batch-level traceability, with a complete record linking raw material lots to finished product lots
- Test data for every batch is fully transparent to customers, with raw test reports available on request
Leadership
Pharma Background × Synthetic Biology Industrialization
Sheng Chen
Founder / General ManagerPfizer Quality Engineer
Implemented world-class pharmaceutical QA methodologies across PathGene's quality system
M.Sc. Biochemical Engineering, NJTECH
Doctoral research at University of Macau, Pharmacy
10+ Years Synbio R&D Experience
Led 20+ projects from lab-scale to ton-level industrial production
Full Industry Chain
Covers enzyme engineering, fermentation, purification, and regulatory filing
Ready to partner with us?
Send an inquiry to our R&D team. We respond within 24 hours and supply samples from 100g.
