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SUZHOU
AMTAISEN
BIOTECH

苏州昂肽森生物科技有限公司

Biopharmaceutical Supply Chain & CDMO Expert

Precision-engineered solutions for biopharmaceutical supply chains and contract development manufacturing — anchored by GMP-compliant fermentation infrastructure and proprietary strain science.

2+
GMP Fermentation Bases
1×
Strain R&D Center
5+
Global Regulatory Standards
About Us · 关于我们

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company_profile.md ● LIVE
$ cat mission.txt

Suzhou Amtaisen Biotechnology is a high-tech enterprise integrating biopharmaceutical supply chain management, CDMO services, and import/export technical solutions.

We combine decades of biosynthesis expertise with internationally certified GMP manufacturing to deliver reliable, scalable solutions for global pharmaceutical clients.

  • Rich experience in biological synthesis and fermentation scale-up
  • Dedicated proprietary strain research and development center
  • Two GMP fermentation facilities meeting international regulatory standards
  • Full-spectrum import/export technical services
  • End-to-end supply chain from API to finished formulation
2+
GMP-Certified
Manufacturing Sites
5+
Global Regulatory
Frameworks Met
Tier1
Biosynthesis
Capability Level
CDMO
Full-Spectrum
Contract Services
core_mission.sys

"To accelerate biopharmaceutical innovation through precision manufacturing, proprietary biological technology, and world-class GMP infrastructure."

Services · 服务项目

Core Capabilities

Three integrated service domains — designed to support every stage of your biopharmaceutical program.

SERVICE_MODULE // 01

Biopharmaceutical Supply Chain Management

End-to-end supply chain orchestration — from raw material procurement and API sourcing to cold-chain logistics, quality assurance, and regulatory documentation. Built for continuity and compliance.

API Sourcing QC / QA Cold Chain Vendor Management
SERVICE_MODULE // 02
CDMO

Contract Development & Manufacturing

Comprehensive CDMO services spanning process development, fermentation scale-up, downstream purification, and cGMP-compliant manufacturing for biologics and fermentation-derived products.

Process Dev Fermentation cGMP Mfg Purification
SERVICE_MODULE // 03

Import & Export Technical Services

Cross-border technical consulting for biopharmaceutical products — regulatory dossier preparation, customs compliance, documentation management, and international logistics coordination.

Regulatory Customs Documentation Logistics
Core Strengths · 核心优势

Why Amtaisen

STRENGTH // 01

Rich Biosynthesis Experience

Decades of accumulated know-how in biological synthesis pathways, microbial fermentation engineering, and bioprocess optimization — enabling efficient, reproducible production of complex biomolecules at industrial scale.

STRENGTH // 02

Proprietary Strain R&D Center

A dedicated in-house research center focused on developing, screening, and engineering proprietary microbial strains with superior yield, purity, and stability — providing a differentiated production foundation unavailable elsewhere.

STRENGTH // 03

Dual GMP-Compliant Fermentation Facilities

Two state-of-the-art fermentation manufacturing bases, designed and operated in full compliance with the standards of major international regulatory authorities. Your product meets the highest global quality benchmarks from day one.

US FDA cGMP EU EMA GMP NMPA (CFDA) ICH Q7 WHO GMP JP GMP
Research & Development · 研发能力

Innovation Infrastructure

Our R&D capabilities form the technological core of all services. From strain engineering to process intensification, the Amtaisen scientific team drives continuous bioprocess innovation.

  • Strain Engineering & Optimization

    Metabolic engineering and directed evolution to build high-performance production strains with improved titer, rate, and yield metrics.

  • Bioprocess Development

    DoE-driven process optimization from shake flask through pilot scale to commercial GMP production with full technology transfer.

  • Analytical Method Development

    Comprehensive characterization and testing methods compliant with ICH guidelines and international pharmacopoeia requirements.

Technology Pipeline ● 5 Active Tracks
Fermentation Scale-up Platform
100% LIVE
High-yield Strain Library
100% LIVE
Downstream Processing Opt.
80% RUN
GMP Process Transfer System
60% RUN
Next-gen Biosynthesis Routes
25% DEV
Contact · 联系我们

Establish Connection

contact_node.cfg ● ONLINE
Office Address · 公司地址

Room 701, Building E7, Zhongyin International Business Garden, Kunshan, Suzhou, Jiangsu, China

昆山中茵国际商务花园E区7楼701室

Email · 邮箱

info@amtaisen.com

Business Scope · 业务范围

Biopharmaceutical Supply Chain · CDMO Services · Import/Export Technical Consulting

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Interested in our capabilities? Complete the form and our team will respond within 1–2 business days.

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