Shanghai Haoyuan Chemexpress Co, Ltd

Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics, and new modalities such as ADCs/XDCs, peptides, and PROTACs. Our comprehensive platform is engaged in the research, development, manufacturing, and supply of regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs, and drug products (solid, semi-solid, biologics, liquid, and lyophilized). We support our clients’ projects from early drug discovery, process development to commercialization.

Description

• ChemExpress’s One-Stop CRO & CDMO services.
• RSMs, novel building blocks, intermediates, APIs/HPAPIs, and Drug products with GMP and FDA/EMA/NMPA regulatory standards.
• Focus on small molecules, biologics, and new modalities such as ADCs, peptides,
  and PROTACs.
• Specialize in ADC/XDC CDMO service and GMP manufacturing.
• Whole process approach from R&D through commercialization.

Type of Drugs Manufactured:

Small Molecule; Biologics; ADC/XDC; Peptides; PROTACS

CDMO Services offer:

Drug Substance Manufacturing (API); Drug Product Formulation (FDF); Research & Development; Regulatory Services; Analytical Development; Intermediates; ADC/XDC; Biologics; Peptides; PROTACS

Number of Manufacturing Facilities:

6-10

High Potent Products capabilities:

OEB 3;OEB 4-5;OEB>5

Facilities Locations:

China

Regulatory Approvals for facilities:

FDA (United States);ISO;GMP;NMPA (China)

Manufacturing Technologies:

Liquids;Lyophilized amps/vials; Semi-solids; Soft Gels; Solids; Sterile Ampoules; Sterile Vials; Oral solid; Tablets, Capsules; Granules

Current Capacity:

1. Small Molecules CRO&CDMO

Drug discovery services (FTE/FFS)

• Synthetic Chemistry
• Medicinal chemistry

Drug Substance GMP Process Development and Manufacturing – RSM, Intermediates, API, and Peptide

• Product types: Anti-tumor, antiviral, diabetic, cardiovascular, cerebrovascular disease, etc.
• 220+ Reactor range from 100L-8000L; Total reactor volume：~598,000L
• Reactions: Hydrogenation reaction, Grignard reaction, oxidation reaction, chlorination reaction, photoreaction, high temperature reaction(220°C), and deep cryogenic reaction (-80°C), etc.

Drug Product GMP Process Development and Manufacturing—Solid, Semi-Solid

• Oral solid dosages (1 billion units per year) and Semi-solid topical dosages (40 million tubes per year)
• Tablets, hard capsules, granules, powder, cream, ointment, gel, and anti-tumor drugs

2. Biologics CRO&CDMO

Antibody/ADC One-stop Service

• Antibody development and manufacturing
• Payload-Linker development and manufacturing
• Conjugation process development and optimization
• Formulation and lyophilization development
• Analytical and Quality Control
• ADC DS manufacturing
• ADC DP manufacturing

Capabilities & Facilities

ADC/XDC Bioconjugation DS & DP CDMO

• 1 Antibody Line: 200L, 500L, 2000L, reserve a number of 2000L production line
• 1 ADC/Conjugation DS Line: 50L, 100L, 200L, 300L, 500L
• 2 DP filling Lines (with Lyophilizer) :10m 2 , 25m 2
• Capacity: 50 batches, about 2 million doses of ADC per year
• XDC types: PDC, RDC, DAC, AOC, etc.

ADC/XDC payload-linker CDMO

• 5 GMP production lines (OEB5, OEL limit down to 1ng/m³), total volume over 4,000L
• Scale up to kilograms (commercial scale）
• Multiple prep-HPLC and Lyophilizers

3. Peptide CRO&CDMO

• High-throughput solid-phase synthesis
• Solid-phase synthesis and liquid-phase synthesis
• Custom synthesis
• Peptide modification
• GMP manufacturing

4. Global Regulatory CMC Filing Support

• Research stage: from pre-clinical stage to commercial stage.
• Main research contents: Process development and optimization, production and process validation, technology transfer, stability research, and preparation of application materials etc.
• Application areas: China, United States, Japan, Korea, etc.

5. Enabling Technologies (Highlights Green Chemistry)

• High Throughput Experimentation
• Biocatalysis
• Flow Chemistry
• Photochemistry
• Preparative Chromatography
• Solid State Chemistry Research
• Spray Dried Dispersion
• Hot Melt Extrusion

6. Quality Assurance Compliance

• 5+ successful EU 3rd party QP on-site GMP audit
• 1 successful US FDA inspection with zero 483 observations
• 6+ successful China NMPA inspections
• 350+ client audits (USA, EU, Canada, China, Israel, etc.)
• 4 joint State and Provincial NMPA on-site PAI and GMP inspections supporting NDA by MAH