Our Story
Pfizer-Trained Quality, Applied to Synthetic Biology
PathGene was founded in Nanjing by a team with direct Pfizer quality engineering experience, bringing the world's most rigorous pharmaceutical QA methodologies to synthetic biology ingredient manufacturing.
≥99.5%
Product Purity
12
Invention Patents
1,500㎡
GMP Facility
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.
In 2018, the founding team returned to Nanjing with a mission: bring Pfizer-level quality standards to the synthetic biology ingredient supply chain. We implemented cGMP manufacturing practices, established ISO 17025-accredited third-party testing protocols, and secured 12 invention patents on our core enzymatic synthesis processes.
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
2018
Company Founded
PathGene Biotech founded in Nanjing by team from Pfizer and Bayer.
2019
First GMP Line Commissioned
1,500m² cGMP facility completed. NMN enzymatic process passes GMP audit.
2020
Patents Granted & International Certifications
First 6 invention patents granted. ISO9001 certified. Products validated against USP/EP dual pharmacopeia.
2021
Global Export Launch
Products enter European, North American, and Southeast Asian markets with full regulatory compliance.
2023
12 Invention Patents
Patent portfolio covers full product line: NMN, NAD⁺, NR, CDP-Choline.
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.
🔬
Science First
Every process decision is driven by science, not cost-cutting.
📋
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.
🌍
Global Compliance
FDA, EMA, NMPA documentation support built into every engagement.
Our Facility
Nanjing · 1,500m² cGMP Facility
Our facility is located in Nanjing Hi-Tech Industrial Development Zone, covering 1,500m² with cGMP-certified clean rooms, fermentation engineering center (50L–8,000L scale), automated QC laboratory, and cold-chain storage systems.
All products undergo independent testing by ISO 17025-accredited third-party laboratories. Full analytical data is available to every customer — our transparency is our strongest endorsement.
1,500 m²
GMP Production Area
50L–8,000L
Fermentation Scale
400 m²
Cold-Chain Storage
24H IoT
Real-Time Monitoring
ISO 17025
Third-Party Testing
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
Leveraging AI algorithms for virtual screening of our proprietary sequence library, PathGene achieves rapid, precise identification of thermostable, alkaline-tolerant, and solvent-resistant enzymes — reducing R&D risk and enhancing chiral purity.
150+
Oxidoreductase Library
18.6GB
Sequence Data Assets
−80%
Screening Cycle Reduction
Digital R&D Advantage
18.65M enzyme protein sequences underpin a digital-first R&D model — from virtual screening to laboratory validation, AI-assisted decision-making throughout.
Leadership
Pharma Background × Synthetic Biology Industrialization
Sheng Chen
Founder / General ManagerPfizer Quality Engineer
Implemented world-class cGMP/ICH standards across PathGene's QA 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.
