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CRDMO Service

Full chain service capability for research, development, and production

With over 20 years of dedication to peptide drug R&D, we have developed technologies for cost reduction, efficiency improvement, product quality enhancement, and new peptide drug development, while establishing a formulation technology platform covering multiple dosage forms.
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Peptide API
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Peptide Formulation
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Oligonucleotide Drugs
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Pharmaceutical Intermediates

Molecular Design

Hybio collaborates with strategic partners to strengthen engagement in AI-driven pharmaceuticals. Leveraging peptide chip detection of peptide-target interactions, a proprietary database is built for large-scale machine learning training. Through reinforcement learning optimization of generation processes, peptide molecules with high target protein binding specificity are designed.

Peptide & API Platform Capabilities

Our API platform offers one-stop services from API development to commercial production, covering process development ranging from mg-scale to 10T-scale in GMP workshops, with an average delivery time of 1.5 months and a fastest turnaround of 25 days.
The peptide platform enables development and production of nearly all marketed peptide APIs, especially developing long-chain peptide APIs (over 30 amino acids) and special complex peptides. It leads peptide synthesis technologies including peptide peptides, peptide aldehydes, various modified peptides, difficult-sequence peptides, cyclic peptides, and peptide nucleic acids. It has industrialized high-tech-difficulty peptide APIs such as liraglutide and glatiramer, being recognized by international partners.
Based on solid production and commercialization experience, the team can deliver customized and diversified commercial production of peptide APIs for customers.
CRDMO (1)

Quality Studies

Equipped with a comprehensive quality research platform meeting application standards, an experienced team specializing in peptide and small molecule mass research, and a robust quality research system, including:
  • CRDMO
    Drug impurity research: 2D-HPLC combined with HRMS identifies process/degradation impurity structures in peptides and oligonucleotides, with tailored control strategies.
  • CRDMO
    Advanced drug structural research: Orthogonal methods (CD, SEC-MALS, AUC) characterize peptide/oligonucleotide secondary/tertiary structures and aggregation, meeting FDA/NMPA review requirements.
  • CRDMO
    In vitro drug activity research: ELISA and cell-based in vitro pharmacological validation/functional evaluation (aligned with indications/pathways) support structural optimization, candidate screening, and quality-activity relationship analysis.
CRDMO (2)

Technology Platform

  • CRDMO
    High Efficiency Separation & Purification Platform: Equipped with UPLC/HPLC, 2D-UPLC, Fraction Collector for separating/purifying peptide/oligonucleotide intermediates and finished products.
  • CRDMO
    Precise Structural Elucidation Platform: Features LC Orbitrap, QTOF, MALDI-TOF, Edman degradation for primary/secondary mass spectrometry sequence analysis of peptide/oligonucleotide intermediates, main components and impurities.
  • CRDMO
    High Sensitivity Quantitative Analysis Platform: Includes LC-TSQ, GC-MS, ICP-MS, CIEF, HPLC-CAD, ELISA Reader for quantitative analysis of peptide/oligonucleotide intermediates and finished products.
  • CRDMO
    Advanced Structure & Physicochemical Property Characterization Platform: Equipped with CD, SEC-MALS, AF4-MALS, DLS, FT-IR, PXRD, DSC, TGA, DVS, KF Titrator, Flow-CAM for characterizing advanced structures and physicochemical properties of peptide and protein drugs.
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Matrix assisted laser desorption time-of-flight mass spectrometer

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240 quadrupole ultra-high field Orbitrap mass spectrometer

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Linear ion trap mass spectrometer

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Single quadrupole inductively coupled plasma mass spectrometer

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Combination quadrupole Orbitrap mass spectrometer

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Triple quadrupole liquid chromatography-mass system

Equipped with advanced mass spectrometry detection equipment to provide support for peptide and oligonucleotide drug analysis.

Production System

Raw material production base: Features multiple solid/liquid-phase workshops with world-class equipment, offering diverse process routes for cost and quality optimization.
Multi-line setup meets varied production scales, preventing capacity shortages or line congestion.
Independent step-by-step processes avoid interference, minimizing confusion, errors, and cross-contamination.

Synthesis Equipment

Automatic Solid-Phase Synthesis System
• 50L Synthesis Kettle
• 100L Synthesis Kettle
• 160L Synthesis Kettle
• 300L Synthesis Kettle
• 500L Synthesis Kettle
• 1200L Synthesis Kettle
Automatic liquid-phase synthesis system
• (1200LSynthesis Kettle)

Purification Equipment

Purification and Preparation Systems (multiple sets of different sizes: DAC100~DAC1200mm)
• 300mm
• 450mm
• 600mm
• 800mm
• 1200mm

Freeze-drying Equipment

Freeze-drying System (capable of freeze-drying 0.1-50kg of products per batch)
• 5㎡
• 15㎡
• 36㎡
• 40㎡

Analytical Equipment

• Equipped with analytical instruments based on different principles, eliminating the need for outsourcing testing
• DMS compliant document management system

Formulation Production Capabilities & Facilities

Multi-dosage GMP formulation development & production line: Capable of developing water injections, pre-filled injections, lyophilized powders, nasal sprays, oral formulations, etc. Equipped to develop complex drug-device combinations, enabling a closed loop from process development to validation production.
Injection production facility (Pingshan, Shenzhen): 25,000㎡, built to EU/US cGMP standards, with advanced lines including 3 vial lines, 1 cartridge line, 1 pre-fill & seal line.
Oral formulation plant (Huangpi, Wuhan): 360-acre site compliant with China/US/EU GMP, featuring oral tablet production lines.
Rich experience in oral/injectable formulation development, meeting global customers’ diverse needs.
CRDMO (3)

Global Regulatory Affairs & Registration Support

Our global regulatory affairs team offers end-to-end registration support (IND/CTA, NDA/ANDA/MAA), tailoring submission materials and strategies. We engage with FDA/CDE and global authorities via multi-channel communication to facilitate market entry.

Quality Studies

Equipped with a comprehensive quality research platform meeting application standards, an experienced team specializing in peptide and small molecule mass research, and a robust quality research system, including:
  • CRDMO
    Drug impurity research: 2D-HPLC combined with HRMS identifies process/degradation impurity structures in peptides and oligonucleotides, with tailored control strategies.
  • CRDMO
    Advanced drug structural research: Orthogonal methods (CD, SEC-MALS, AUC) characterize peptide/oligonucleotide secondary/tertiary structures and aggregation, meeting FDA/NMPA review requirements.
  • CRDMO
    Packaging compatibility research: Customized plans for diverse dosage forms and packaging (borosilicate glass, rubber stoppers, plastic containers, etc.), with full reports complying with pharmacopoeias/regulations.
CRDMO (4)

Technology Platform

  • CRDMO
    High Efficiency Separation & Purification Platform: Equipped with UPLC/HPLC, 2D-UPLC, Fraction Collector for separating/purifying peptide/oligonucleotide intermediates and finished products.
  • CRDMO
    Precise Structural Elucidation Platform: Features LC Orbitrap, QTOF, MALDI-TOF, Edman degradation for primary/secondary mass spectrometry sequence analysis of peptide/oligonucleotide intermediates, main components and impurities.
  • CRDMO
    High Sensitivity Quantitative Analysis Platform: Includes LC-TSQ, GC-MS, ICP-MS, CIEF, HPLC-CAD, ELISA Reader for quantitative analysis of peptide/oligonucleotide intermediates and finished products.
  • CRDMO
    Advanced Structure & Physicochemical Property Characterization Platform: Equipped with CD, SEC-MALS, AF4-MALS, DLS, FT-IR, PXRD, DSC, TGA, DVS, KF Titrator, Flow-CAM for characterizing advanced structures and physicochemical properties of peptide and protein drugs.
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Peptide Formulation Capabilities & Advantages

Comprehensive one-stop "lab scale → pilot → commercialization" CDMO services
•  Internationally certified facilities: GMP certified by NMPA, FDA, EMA, ANVISA, MOH (Pakistan), BPOM (Indonesia) since 2013.
•  Agile response: Flexible, efficient custom solutions (process development, clinical/commercial production) to shorten R&D cycles, cut costs, and meet market demands.
•  Superior quality system: Aligned with NMPA, ICH, FDA, EMA standards. Integrated DMS, LIMS, EMS/BMS enable full-process traceability and real-time monitoring, building a GMP-compliant, data-driven, risk-controlled intelligent quality system.
•  Advanced hardware & software: Imported key production/inspection equipment; automated injection lines with multi-country process control tech to reduce human error.

Vial Production Line

• Certified by China NMPA, US FDA, EU EMA, Brazil ANVISA, Pakistan MOH, Indonesia BPOM, etc.  
• Vials specifications: 2ml, 6ml, 10ml 
•Filling volume: 0.5–25 ml
•Annual capacity: 50 million vials

Cartridge bottle Production Line

•Small-volume injections (non-terminal sterilization)  
Certified by China NMPA, US FDA  
Batch range: 30L-300L  
Cartridge bottle specifications: 3ml  
Filling volume: 1.5–3.3 ml 
Annual capacity: 30 million vials
•Large-volume injections (non-terminal sterilization)  
Batch range: 30L-300L  
Vials specifications: 100ml  
Filling volume: 1–100 ml
Annual capacity: 15 million vials

Pre-filled Syringe Production Line

• Batch range: 15L-500L 
• Filling volume: 0.5–1 ml 
• Annual capacity: 30 million syringes

Process Development

We have an oligonucleotide drug R&D platform covering the entire process from laboratory research to process scale-up. It can provide custom oligonucleotide synthesis services ranging from μmol to mmol scale, with extensive research experience in customized modification, process development, pilot-scale amplification, and other aspects.
Our services cover all types of oligonucleotides and provide quality research, analysis, and testing support for the entire process.
CRDMO (8)
References：Trends in Pharmacological Sciences, 2022, 43, 455-456.

Quality Studies

The quality research team has accumulated rich experience in the development of oligonucleotide drugs and has a profound understanding of the quality research projects for oligonucleotide drug development by EU and US regulatory agencies.
Sameness Primary sequence, chemical structure and composition Primary sequence, chemical structure and composition of chains, double chains and residual single chains, composition of diastereomers, ratio of P=S to P=O
Physical and Chemical Properties Consistent with the original drug
Gathering state Consistent with the original drug
​​Impurities Product related impurities (single chain molecules) Reporting limit: Limit of quantitation (LoQ) Identification limit: 1.0% Confirmation limit: 1.5% New impurity content shall not exceed 1.0%
Common Impurities The content should be ≤ Reference Preparation (RLD)
​​Risk Assessments Immunogenic risk Need to evaluate whether it is necessary to conduct testing
Inflammatory risk Need to evaluate whether it is necessary to conduct testing

Production System

Capable of laboratory synthesis and collaborating with the oligonucleotide production workshop of the raw material drug production base to achieve the transition from preclinical research samples to commercial production. In response to the water oxygen sensitivity of oligonucleotide drugs, advanced oligonucleotide synthesis equipment is introduced to achieve full process automatic synthesis.
Production System

Process Development

Fragment peptides are important intermediates in the synthesis of long peptide drugs and are essential for the commercial production of peptide drugs containing ≥ 15 amino acids.
Provide feasible guarantee for the synthesis of long peptides: the yield of direct synthesis of long peptide chains with more than 30 amino acids drops sharply to<5% (cumulative side reactions), while the segmented intermediate strategy increases the yield to over 60%.
Realize precise control of key modification sites: complete disulfide bond cyclization (such as insulin), phosphorylation (such as parathyroid hormone) and other modifications in the intermediate stage.
Efficient impurity interception mechanism: Intermediate purification (HPLC/MS) can intercept 90%+missing peptides/truncated peptides, reducing the burden of impurities in the final product.
Hanyu Pharmaceutical's API platform relies on solid experience in peptide API production and commercialization. The team can undertake the development of fragment peptide processes of any scale and peptide sequence, and provide customers with customized and diversified peptide intermediates and starting materials for commercial production.
CAS Product Name Other
1662688-20-1 Fmoc-L-Lys[Ste(OtBu)-γ-Glu-(OtBu)-AEEA-AEEA]-OH Intermediate of Simeglutide
1169630-40-3 Ste-γ-Glu-AEEA-AEEA-OSU
1890228-73-5 Boc-His(Trt)-Aib-Glu(OtBu)-Gly-OH
1446013-07-5 Fmoc-His-Aib-OH
/ Fmoc-Lys(Pal-Glu-OtBu)-OH Intermediate of Liraglutide
1418291-58-3 Boc-His(Trt)-Ala-Glu(OtBu)-Gly-OH
2915356-76-0 Fmoc-L-Lys[Eic(OtBu)-γ-Glu(OtBu)-AEEA-AEEA]-OH Intermediate of Tilpotide
2639221-78-4 Boc-Tyr(tBu)-Aib-OH
2171139-20-9 Fmoc-Ile-Aib-OH
2682040-93-1 Boc-Tyr(tBu)-Aib-Glu(OtBu)-Gly-OH
2612237-97-3 Fmoc-L-Lys[Eic(OtBu)-γ-Glu(OtBu)-AEEA]-OH Intermediate of Ritaglutide
/ Fmoc-Ile-αMeLeu-Leu-OH
/ Boc-His(Trt)-Aib-Gln(Trt)-Gly-OH
1143516-05-5 AEEA-AEEA Other peptide intermediates
1962160-86-6 Fmoc-Thr(tBu)-Phe-OH
35897-09-5 Fmoc-Gly-Gly-OH