Small Molecule Pharmaceutical Services

Small Molecule Drug Development from Discovery to Commercialization

Small molecule drug development requires more than chemical synthesis. A process that works at laboratory scale may need substantial modification before it can support reproducible GMP manufacturing and commercial supply.

Lianhe Aigen integrates small molecule drug development, process chemistry, analytical development, manufacturing, and CMC support to help projects progress through key development stages.

This integrated model helps maintain technical and quality continuity as a molecule moves from laboratory research to larger-scale manufacturing.

Through its Process Development platform, Lianhe Aigen supports APIs, intermediates, registered starting materials and other pharmaceutical materials across preclinical, clinical and commercial stages.

Small Molecule CDMO Services

Our small molecule CDMO services cover the major development and manufacturing activities required to move pharmaceutical compounds from early research toward commercial supply.

Drug Discovery & Custom Synthesis

Lianhe Aigen provides chemistry-related services across different stages of drug discovery, including custom synthesis and preparation of pharmaceutical compounds.

• Custom synthesis
• Small molecule compound preparation
• Building block synthesis
• Intermediate synthesis
• Route feasibility assessment
• Complex molecule synthesis
• Preclinical material preparation
• Scale-up from milligram to kilogram levels

The goal is to establish a practical connection between early chemistry research and subsequent process development. Projects requiring broader discovery support can be connected with our Drug Discovery capabilities.

Small Molecule Process Development

A scalable synthesis requires consideration of reaction efficiency, impurity formation, process safety, raw material availability, equipment compatibility, cost, and regulatory requirements.

Our small molecule process development services include:

• Synthetic route scouting
• Route selection
• Process development
• Process optimization
• Reaction condition optimization
• Yield and purity improvement
• Impurity characterization and control
• Process safety evaluation
• Crystallization development
• Crystal form optimization
• Residual solvent assessment
• Elemental impurity assessment
• Genotoxic impurity assessment
• Process validation
• Technology transfer
• Scale-up support

Lianhe Aigen applies Quality by Design concepts to process development and CMC activities, with capabilities for complex and hazardous chemistry. Detailed process chemistry, analytical development, process safety and scale-up activities are available through the dedicated Process Development platform.

API & Drug Substance Development

Our small molecule API development and drug substance services support projects from early development through GMP manufacturing and commercial supply.

• API route scouting
• API process development
• Drug substance synthesis
• Process optimization
• Impurity profiling
• Crystallization
• Analytical method development
• Process validation
• Technology transfer
• GMP manufacturing
• DMF and CMC documentation support
• Clinical and commercial material supply

For projects requiring advanced synthesis capabilities, our API platform supports complex chemistry including hydrogenation, halogenation, nitration, cryogenic reactions and high-potency compound handling. More detailed API development and manufacturing capabilities are available through our API Production and Contract API Manufacturing services.

Pharmaceutical Intermediate Manufacturing

Pharmaceutical intermediates are an important part of the small molecule manufacturing supply chain. Lianhe Aigen provides pharmaceutical intermediate development and manufacturing services for projects requiring customized synthesis, process optimization, analytical support and scalable production.

• Pharmaceutical intermediates
• Advanced intermediates
• Registered starting materials
• Key starting materials
• Custom synthesis
• Process development
• Process optimization
• Analytical testing
• GMP manufacturing
• Clinical-stage supply
• Commercial-scale production

For dedicated intermediate development and production requirements, see our Intermediates Pharma Service, which covers customized intermediate development, manufacturing and analytical support.

Projects involving advanced intermediates and registered starting materials can also be supported through our Advanced Intermediates Service and Registered Starting Material Pharma Service.

GMP Manufacturing & Scale-Up

Moving from laboratory synthesis to reliable manufacturing requires controlled scale-up, suitable equipment, process validation and a robust quality system.

Lianhe Aigen provides small molecule GMP manufacturing from development and pilot stages through commercial production.

• Laboratory-to-pilot scale-up
• Pilot production
• Kilo-scale manufacturing
• GMP API manufacturing
• GMP intermediate manufacturing
• Process validation
• Technology transfer
• Clinical batch production
• Commercial production
• Long-term supply
• Customized manufacturing facilities

Our Contract Manufacturing platform supports pharmaceutical raw materials, intermediates and APIs from laboratory and pilot stages through commercial manufacturing. Dedicated GMP requirements can also be addressed through the API GMP Certified Factory platform.

CMC & Regulatory Support

Small molecule development also requires consistent CMC documentation and quality data as a project advances toward clinical trials and commercialization.

Our CMC services for small molecule drugs cover:

• Synthetic route development
• Impurity characterization
• Impurity control strategy
• Quality control strategy
• Analytical method development
• Analytical method validation
• Critical process parameter identification
• Process validation
• Stability studies
• Regulatory documentation
• Global submission support
• Preclinical material supply
• Commercial material supply
• Transportation validation

Our dedicated CMC Service integrates route scouting, impurity characterization, analytical development, process validation, stability studies, regulatory documentation and manufacturing support throughout the drug development lifecycle.

Small Molecule Chemistry & Technology Capabilities

Complex small molecule projects often require chemistry and process technologies beyond conventional batch synthesis. Lianhe Aigen combines process chemistry, production engineering and technology platforms to support challenging pharmaceutical manufacturing requirements.

Flow Chemistry

Flow chemistry can provide improved reaction control, heat and mass transfer, and safer handling for selected chemical reactions.

Lianhe Aigen applies flow chemistry as part of its production technology platform and combines it with other process technologies for pharmaceutical manufacturing. Projects involving continuous processing can be evaluated according to reaction characteristics, scale and manufacturing requirements.

Biocatalysis

Enzyme-based synthesis can provide an alternative approach for selected pharmaceutical intermediates and APIs, particularly where stereoselectivity or reaction efficiency is important.

Biocatalytic routes can be evaluated during process development alongside conventional chemical synthesis to determine the most suitable approach for a specific molecule.

Electrochemistry & Photochemistry

Electrochemical and photochemical processes can provide alternative reaction pathways for selected small molecule synthesis and process development projects.

These technologies form part of Lianhe Aigen's broader production technology platform and can be considered when conventional synthetic routes do not provide the desired process efficiency or selectivity.

Solid-State Chemistry

Solid-state development can influence crystallization, physical properties, purification and the final quality of a drug substance.

Lianhe Aigen's process development capabilities include recrystallization and crystal-form development, helping integrate solid-state considerations into API and drug substance development.

Projects requiring dedicated solid-state expertise can be connected with our Solid State Chemistry capabilities.

Complex & Hazardous Chemistry

Our process development and manufacturing capabilities are designed to address complex and hazardous chemical processes, supported by appropriate process safety evaluation and specialized equipment.

• Low-temperature reactions
• High-temperature reactions
• Hydrogenation
• High-pressure reactions
• Hazardous chemistry
• High-potency compound handling
• Specialized reaction equipment
• Process safety assessment

Small Molecule API & Drug Substance Manufacturing

For programs that have moved beyond laboratory research, manufacturing consistency becomes a central consideration.

Lianhe Aigen supports small molecule API manufacturing from early development to commercial production, integrating process development, scale-up, analytical testing, quality assurance and regulatory documentation.

Our API manufacturing capabilities cover:

• Small molecule APIs
• Drug substances
• Advanced intermediates
• Pharmaceutical intermediates
• Registered starting materials
• Highly potent compounds
• Complex synthetic routes
• Multi-step synthesis
• Clinical supply
• Commercial supply

The manufacturing platform includes kilo labs, pilot plants and multi-purpose production facilities, supporting scale-up from grams to multi-ton production depending on project and facility requirements.

For projects requiring dedicated API manufacturing capabilities, see API Production and Contract API Manufacturing. Projects requiring GMP facility information can be directed to our API GMP Certified Factory service.

Small Molecule Manufacturing Capacity

Lianhe Aigen's production technology platform combines R&D laboratories, kilogram-scale facilities, pilot plants and cGMP multi-purpose workshops.

The appropriate production route and manufacturing scale are selected according to molecule characteristics, process requirements, development stage, quality requirements and commercial demand.

Quality, GMP & Regulatory Compliance

Quality and regulatory compliance are integrated throughout the small molecule development and manufacturing process.

• GMP manufacturing
• Quality control
• Analytical method development
• Analytical method validation
• Impurity characterization
• Stability studies
• Process validation
• Cleaning validation
• Change control
• Deviation management
• Regulatory documentation
• CMC documentation
• DMF support
• Health authority inspection preparation

Lianhe Aigen's manufacturing platform is designed to support international pharmaceutical quality and regulatory requirements. Our facilities have experience with inspections or regulatory requirements involving authorities including FDA, EMA, PMDA, TGA, KFDA and NMPA.

For API manufacturing projects, our quality and documentation systems also support relevant ICH expectations. More information about GMP manufacturing facilities is available through our API GMP Certified Factory service.

Analytical Development & Quality Control

Analytical development is an important component of small molecule pharmaceutical services, particularly when a project moves from laboratory synthesis to GMP manufacturing.

Our analytical and quality support can cover:

• Method development
• Method optimization
• Method validation
• Impurity analysis
• Structural confirmation
• Specification development
• Stability studies
• Residual solvent analysis
• Elemental impurity assessment
• Genotoxic impurity assessment
• Quality control strategy
• Process-related impurity control
• Batch testing and release support

Analytical data can be incorporated into process development, CMC strategy and regulatory documentation to maintain continuity throughout the development and manufacturing lifecycle.

Small Molecule Development by Project Stage

Preclinical Development

For early-stage programs, services can include custom synthesis, route assessment, process development, analytical method development and preparation of development materials.

IND-Enabling Development

At the IND-enabling stage, greater emphasis is placed on process robustness, impurity control, analytical methods, process safety, material consistency and CMC documentation.

Phase I Clinical Supply

Small molecule CDMO support can include process scale-up, GMP manufacturing, analytical testing, process validation and clinical API or drug substance supply.

Phase II & Phase III Development

As clinical demand increases, process optimization, manufacturing capacity, supply chain reliability, technology transfer and regulatory consistency become increasingly important.

Commercial Manufacturing

For commercial programs, Lianhe Aigen provides GMP API and intermediate manufacturing, process validation, quality control, regulatory support and ongoing commercial supply.

This lifecycle approach connects process development, manufacturing, quality and regulatory activities instead of treating each activity as an isolated service.

Why Choose Lianhe Aigen for Small Molecule CDMO Services?

Integrated Development & Manufacturing

Drug discovery, process development, CMC, contract manufacturing and regulatory support can be coordinated within one integrated platform.

Complex Chemistry Expertise

The technology platform supports complex and hazardous chemistry together with flow chemistry, enzyme catalysis, electrochemistry, photochemistry and other process technologies.

Scalable Manufacturing

Production capabilities extend from laboratory and kilogram-scale development through pilot and commercial manufacturing, depending on project requirements.

Global Regulatory Support

Lianhe Aigen's facilities have experience with international regulatory requirements and health authority inspections involving FDA, EMA, PMDA, TGA, KFDA and NMPA.

Lifecycle Support

The integrated platform can support pharmaceutical programs from discovery and process development through clinical and commercial manufacturing.

Quality-Focused Delivery

Process validation, analytical development, impurity control, stability studies and CMC documentation can be integrated into the development and manufacturing process.

Related Small Molecule Products & Intermediates

Lianhe Aigen's product portfolio includes building blocks, pharmaceutical intermediates and other small molecule materials used in pharmaceutical research and development.

The Product Center can be used alongside customized small molecule CDMO projects when a required compound, intermediate or starting material is already available within the portfolio.

Small Molecule Pharmaceutical Services FAQs