About Peptide Science Biochem
The Aircraft Carrier of the Global Peptide Industry 世界多肽产业的航母
Peptide Science Biochem (Shanghai) Ltd. 肽科生化（上海）有限公司
Peptide Science Biochem is a large-scale international biochemistry enterprise and one of the world's foremost manufacturers of protected amino acids, synthetic peptides, coupling reagents, and antibody products. Headquartered at 519 Ziyue Road in the prestigious Zizhu Hi-Tech Industrial Development Zone, Minhang District, Shanghai, the company commands over 100,000 square meters of purpose-built research, development, and manufacturing facilities across multiple sites in China and internationally.
Founded on May 11, 1998 in the Zhangjiang Hi-Tech Park, Shanghai, Peptide Science Biochem has grown from a seven-person startup occupying 188 square meters into a multinational corporation with eight subsidiary companies, three dedicated R&D centers, and international offices spanning Canada, the United States, and Australia. The company is led by a world-class team of domestic and international PhD-level scientists and executives with deep expertise in peptide chemistry, process development, and pharmaceutical manufacturing.
With over 25 years of quality management experience, recognized as a National High-Tech Enterprise for 10 consecutive years, and certified under ISO 9001:2015, ISO 14001, OHSAS 18001, and cGMP standards, Peptide Science Biochem delivers the highest quality products at competitive pricing to researchers, pharmaceutical companies, and institutions across more than 60 countries worldwide. The company is widely regarded as the definitive global leader in peptide manufacturing and amino acid supply.
Production & Equipment 生产与设备
World-class instrumentation and manufacturing infrastructure for peptide production at any scale
NMR Spectroscopy
400 MHz Nuclear Magnetic Resonance spectrometer for definitive structural characterization of synthesized peptides and amino acid derivatives, ensuring molecular identity confirmation for every product.
FT-IR Analysis
Two Fourier-Transform Infrared spectrometers providing rapid functional group identification and purity verification, supporting quality control workflows across all production lines.
Mass Spectrometry
Ten LC-MS systems incorporating both ESI (Electrospray Ionization) and MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization — Time of Flight) for precise molecular weight determination and peptide sequencing.
HPLC Systems
Over 200 High-Performance Liquid Chromatography systems for analytical quality control, preparative purification, and purity assessment. Every product undergoes rigorous HPLC analysis with full COA documentation.
Amino Acid Analyzer
Dedicated amino acid analyzer for precise compositional analysis of peptide hydrolysates, ensuring accurate amino acid ratios and confirming peptide sequence integrity in manufactured products.
Automated Peptide Synthesizers
96-well and 102-well automated peptide synthesizers plus microwave-assisted peptide synthesizer for high-throughput parallel synthesis, combinatorial library generation, and accelerated reaction kinetics.
24-Hour Continuous Production
Manufacturing facilities operate on a 24-hour continuous production schedule across multiple shifts, ensuring maximum throughput and rapid order fulfillment for both catalog and custom synthesis orders.
cGMP Manufacturing
10,000 sq ft cGMP-compliant workshop for pharmaceutical-grade peptide API manufacturing, meeting the stringent requirements of drug development and clinical supply applications.
Lyophilization Capability
Dedicated lyophilized powder pilot workshop at Jiangsu Jitai for freeze-drying of peptide formulations, producing stable, long-shelf-life products for pharmaceutical and research applications.
R&D Capabilities 研发能力
Sustained investment in research and development driving continuous innovation in peptide science
Innovation at the Core of Everything We Do
Peptide Science Biochem invests 15% of annual revenue into research and development — a level of commitment that places the company among the most R&D-intensive organizations in the global peptide industry. This sustained investment has yielded a formidable portfolio of intellectual property and technical capabilities.
The company holds over 200 Chinese patents and has published more than 20 peer-reviewed scientific papers in leading journals. Peptide Science Biochem's R&D teams introduce over 100 new products annually to the catalog, continually expanding the range of protected amino acids, specialty reagents, and peptide products available to the global research community.
Peptide Science Biochem has led or participated in more than 10 key national and Shanghai-level scientific research projects, and is recognized as the developer of China's first large-scale high-purity peptide production platform. The company has pioneered leading Fmoc solid-phase peptide synthesis (SPPS) technology that is now widely adopted across the domestic pharmaceutical industry.
During the COVID-19 pandemic, Peptide Science Biochem played a critical role in the national scientific response by providing antigen peptide support for diagnostic and research applications, and by collaborating with the Chinese Academy of Sciences (CAS) Shanghai Institute on anti-SARS drug research programs.
Our Capabilities 核心能力
End-to-end peptide manufacturing, custom synthesis, and pharmaceutical development services
Protected Amino Acids
Complete range of Fmoc, Boc, Z-CBZ, and specialty protected amino acids for solid-phase peptide synthesis. Unnatural amino acids, N-methyl derivatives, pseudoproline dipeptides, and amino alcohols — all manufactured in-house with rigorous quality control.
Custom Peptide Synthesis
Made-to-order peptide synthesis at any scale — from milligram research quantities to multi-kilogram production batches. Any sequence, any length, any purity specification. Modifications including cyclization, PEGylation, fluorescent labeling, biotin conjugation, and isotope labeling.
Catalog Peptides
Extensive library of ready-to-ship research peptides including hormones, neuropeptides, antimicrobial peptides, cell-penetrating peptides, and signaling peptides with full COA documentation including HPLC and MS data.
Pharmaceutical APIs
cGMP-grade pharmaceutical peptide APIs including Leuprolide, Octreotide, Goserelin, Desmopressin, Eptifibatide, and other therapeutic peptides for drug development and clinical supply, manufactured in our 10,000 sq ft cGMP workshop.
Cosmetic Peptides
Bioactive peptides for skincare and cosmetic applications including Argireline, Matrixyl, GHK-Cu, Palmitoyl Tripeptide-1, and other anti-aging and skin-repair peptides manufactured to cosmetic-grade specifications.
Antibody Services
Custom antibody development, monoclonal and polyclonal antibody production, antibody conjugation services, and peptide-antibody coupling for research, diagnostic, and therapeutic applications.
Coupling Reagents
High-purity peptide coupling reagents including HBTU, HATU, PyBOP, DIC, and specialty activating agents. Peptide Science Biochem's flagship HBTU reagent achieves 99.8% purity, exceeding international equivalents.
Analytical Services
Comprehensive analytical services including HPLC purity analysis, LC-MS molecular weight confirmation, amino acid analysis, NMR structural verification, and full Certificate of Analysis documentation for every product.
Global Supply Chain
Worldwide shipping from multiple production bases with temperature-controlled logistics, proper packaging for sensitive biologics, and full tracking. Orders delivered to over 60 countries with responsive lead times.
Quality & Certifications 资质认证
Rigorous quality management systems and nationally recognized certifications across all operations
ISO 9001:2015
Quality Management System — SGS certified. Comprehensive quality management covering all manufacturing processes, quality control procedures, documentation, and continuous improvement across all production bases.
OHSAS 18001 (GB/T 28001)
Occupational Health & Safety Management — Certified system ensuring workplace safety, employee health protection, and occupational hazard prevention across all laboratory and manufacturing environments.
ISO 14001 (GB/T 24001)
Environmental Management System — CAC certified. Systematic approach to environmental responsibility including waste management, emissions control, and sustainable manufacturing practices.
cGMP Manufacturing
Current Good Manufacturing Practice — 10,000 sq ft cGMP-compliant workshop for pharmaceutical-grade peptide API production, meeting the stringent requirements of regulatory agencies worldwide.
Drug Production License
Valid Pharmaceutical Production License — Authorized by Chinese regulatory authorities for the production of pharmaceutical-grade peptide drugs and active pharmaceutical ingredients.
Shanghai S&T Progress Award
Third Prize, 2008 — Shanghai Science & Technology Progress Award for the development of the Eptifibatide manufacturing process, recognizing Peptide Science Biochem's contribution to pharmaceutical peptide production technology.
National High-Tech Enterprise
Recognized for 10 consecutive years — Officially designated as a National High-Tech Enterprise by the Chinese government, reflecting sustained innovation, technological advancement, and R&D investment.
Shanghai S&T Little Giant
Designated 2016 — Recognized as a Shanghai Science & Technology "Little Giant" Enterprise, a distinction awarded to high-growth technology companies demonstrating exceptional innovation capabilities.
National "Specialized Little Giant"
MIIT 3rd Batch, 2021 — Designated by the Ministry of Industry & Information Technology as a national "Specialized, Refined, Differentiated & Innovative" Little Giant Enterprise, recognizing Peptide Science Biochem's market-leading position.
Patent Work Pilot Enterprise
Shanghai, 2014 — Designated as a Shanghai Patent Work Pilot Enterprise in recognition of the company's outstanding intellectual property management, patent portfolio development, and innovation strategy.
Subsidiaries & Global Network 子公司与全球网络
8 subsidiary companies across China with international offices in North America and Australia
Peptide Science Biochem (Shanghai) Ltd.
519 Ziyue Road, Minhang District, Shanghai
GLOBAL HEADQUARTERS
Binhai GL Peptide Co., Ltd.
Binhai, Jiangsu Province
Large-scale production base
Wuxi Yapeptide Co., Ltd.
Wuxi, Jiangsu Province
Peptide manufacturing
Wuxi Maituo Co., Ltd.
Wuxi, Jiangsu Province
Specialty products
Kanghua (Shanghai) R&D Co., Ltd.
Shanghai
Research & development
Shanghai Jifeng Biotech Co., Ltd.
Shanghai
Biotech development
GL Peptide Biopharma (Dalian) Co., Ltd.
Dalian, Liaoning Province
Biopharma manufacturing
Jiangsu Jitai Peptide Tech Co., Ltd.
Jiangsu Province
Lyophilization & peptide tech
International Offices & Subsidiaries
Quality Control & Analytical Capabilities 质量控制与分析能力
Dedicated QC infrastructure ensuring every product meets the highest standards of purity, identity, and safety
HPLC Analysis
200+ HPLC systems for analytical purity determination, preparative purification, and method development. Every product ships with a detailed HPLC chromatogram as part of the Certificate of Analysis.
LC-MS Mass Spectrometry
10 LC-MS mass spectrometers incorporating ESI and MALDI-TOF ionization for precise molecular weight confirmation, peptide sequencing, and impurity identification. MS spectrum included in every COA.
400 MHz NMR Spectroscopy
400 MHz Nuclear Magnetic Resonance spectrometer for definitive structural characterization, conformational analysis, and molecular identity verification of synthesized peptides and amino acid derivatives.
Amino Acid Analyzer
Dedicated amino acid analyzer for precise compositional analysis of peptide hydrolysates, ensuring accurate amino acid ratios and confirming sequence integrity. Amino acid composition data included in COA.
Karl Fischer Titration
Karl Fischer moisture analysis for precise water content determination in peptide powders and lyophilized products. Critical for ensuring product stability, shelf life, and accurate peptide content calculations.
Optical Rotation Measurement
Polarimetry for optical rotation measurement, verifying the chiral purity and enantiomeric integrity of amino acids and peptide products — essential for confirming correct stereochemistry.
Residual Solvent Analysis
GC-FID and GC-MS for residual solvent determination in accordance with ICH Q3C guidelines. Ensures all products meet pharmacopeial limits for residual solvents including DMF, DCM, TFA, and acetonitrile.
Elemental Analysis
CHN analyzer for carbon, hydrogen, and nitrogen elemental analysis, providing independent confirmation of molecular formula and peptide content through nitrogen determination methods.
Endotoxin Testing
LAL (Limulus Amebocyte Lysate) test for bacterial endotoxin detection, ensuring pharmaceutical-grade peptides meet stringent endotoxin limits required for injectable and in vivo applications.
Peptide Content Analysis
Nitrogen determination methods for accurate peptide content quantification, providing net peptide content values essential for precise dosing in research and pharmaceutical applications.
Heavy Metals Analysis
ICP-MS (Inductively Coupled Plasma Mass Spectrometry) for trace-level heavy metals detection including lead, mercury, arsenic, and cadmium, meeting USP/EP pharmacopeial requirements.
Microbiological Testing
Comprehensive microbiological testing including total aerobic microbial count, total yeast and mold count, and absence testing for specified organisms — ensuring product safety for pharmaceutical applications.
Stability Testing
Stability studies conducted in accordance with ICH guidelines (Q1A–Q1E) under accelerated and long-term storage conditions, establishing shelf life, recommended storage conditions, and packaging requirements.
Comprehensive Certificate of Analysis (COA)
Every product shipped by Peptide Science Biochem is accompanied by a comprehensive Certificate of Analysis documenting the complete analytical profile. Each COA includes: HPLC chromatogram, MS spectrum, amino acid composition, appearance description, solubility data, water content (Karl Fischer), and peptide content (net peptide). For pharmaceutical-grade products, additional documentation includes endotoxin levels, heavy metals data, microbiological results, and residual solvent profiles.
Global Compliance & Regulatory 全球合规与法规
Comprehensive regulatory filings and compliance frameworks supporting pharmaceutical clients worldwide
DMF — US FDA Drug Master File
Drug Master File (DMF) filings with the United States Food and Drug Administration for key peptide APIs. DMF filings provide US-based pharmaceutical companies with the regulatory documentation needed to reference Peptide Science Biochem's manufacturing processes, facilities, and quality systems in their own drug applications (IND/NDA/ANDA).
CEP — European Pharmacopoeia Certificate
Certificate of European Pharmacopoeia (CEP) for key active pharmaceutical ingredients, granted by the EDQM. CEP certification confirms that Peptide Science Biochem's manufacturing processes and quality controls for specified APIs comply with the European Pharmacopoeia monograph requirements, facilitating market access across all EU member states.
China NMPA Drug Production License
National Medical Products Administration (NMPA) Drug Production License authorizing Peptide Science Biochem for the manufacture of pharmaceutical-grade peptide drugs and active pharmaceutical ingredients under Chinese regulatory oversight.
ICH Q7 — API Manufacturing
Full compliance with ICH Q7 Good Manufacturing Practice guidelines for active pharmaceutical ingredients, covering production, quality control, documentation, validation, and change control for pharmaceutical-grade peptide manufacturing.
ICH Q11 — Drug Substance Development
Compliance with ICH Q11 guidelines for the development and manufacture of drug substances, applying systematic approaches to process development, control strategy definition, and lifecycle management of peptide API manufacturing processes.
EU GMP Compliance
European Union Good Manufacturing Practice compliance for pharmaceutical clients in the EU market. Manufacturing facilities and quality systems meet the requirements of EudraLex Volume 4, supporting European pharmaceutical companies in their regulatory submissions.
REACH Registration
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) registration for the European Union market, ensuring compliance with EU chemical safety regulations for all relevant products exported to EU member states.
TSE/BSE Free Declaration
TSE/BSE (Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy) free declaration confirming that Peptide Science Biochem's products and manufacturing processes are free from TSE/BSE risk, in accordance with EMEA/410/01 guidelines.
Animal-Free Raw Materials
Animal-free raw materials declaration available for products manufactured using exclusively synthetic or non-animal-derived starting materials, meeting the requirements of clients with animal-origin-free supply chain mandates.
Controlled Substance License
Controlled substance handling license where applicable, authorizing Peptide Science Biochem to manufacture and supply peptides and intermediates that fall under controlled substance regulations, with full chain-of-custody documentation.
Sustainability & ESG 可持续发展
Committed to environmental stewardship, responsible operations, and positive community impact
Environmental
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ISO 14001 Environmental Management
Certified environmental management system (CAC certified) implementing systematic controls on emissions, waste, and resource consumption across all production bases.
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Solvent Recovery & Recycling
Advanced solvent recovery systems achieving >90% solvent recovery rate, dramatically reducing hazardous waste generation and raw material consumption in peptide synthesis operations.
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Waste Water Treatment
On-site waste water treatment facilities at all production bases, ensuring all liquid effluent meets or exceeds local and national discharge standards before release.
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Carbon Footprint Reduction
Active initiatives to reduce carbon emissions through energy efficiency improvements, process optimization, and evaluation of renewable energy integration across manufacturing facilities.
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Green Chemistry Research
Dedicated research program exploring greener synthesis routes, solvent substitution, catalytic methods, and waste minimization strategies to reduce the environmental impact of peptide manufacturing.
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Employee Health & Safety
Certified under OHSAS 18001 / ISO 45001 occupational health and safety management systems, with comprehensive workplace safety programs, regular training, and continuous risk assessment across all facilities.
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Community Engagement & Scholarships
Active community engagement programs and scholarship initiatives supporting education in chemistry and life sciences, nurturing the next generation of scientists and contributing to local community development.
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Supply Chain Responsible Sourcing
Commitment to responsible sourcing throughout the supply chain, with supplier qualification programs, regular audits, and requirements for ethical labor practices and environmental compliance among all key suppliers.