Drug Development Acceleration Services

Lianhe Aigen provides integrated Drug Development Acceleration Services for pharmaceutical companies developing small molecule drugs from early development through clinical and commercial manufacturing. By connecting process development, analytical development, CMC, scale-up, GMP manufacturing and supply activities, the integrated model helps reduce avoidable delays between development stages.

As a CRDMO, Lianhe Aigen combines pharmaceutical R&D and manufacturing capabilities within one service platform. This allows development activities to be coordinated earlier, technical information to move more efficiently between teams, and manufacturing requirements to be considered before late-stage scale-up.

The objective of Drug Development Acceleration is not simply to complete individual development activities faster. It is to reduce repeated work, technology transfer gaps, late-stage process changes and other avoidable delays across the development pathway.

Integrated Drug Development Services

Drug development involves multiple technical functions, including synthetic chemistry, process development, analytical development, CMC, scale-up and GMP manufacturing. When these activities are managed through disconnected service providers, additional technology transfers and project interfaces can increase development complexity.

Lianhe Aigen's Integrated Drug Development Services connect these activities through an integrated CRDMO platform.

• Drug discovery and synthetic chemistry support
• Process development and process optimization
• Analytical method development and validation
• Impurity characterization and control
• Process safety evaluation
• Crystallization and solid-state chemistry
• Process scale-up
• CMC development and regulatory documentation
• GMP API manufacturing
• Clinical and commercial manufacturing support
• Technology transfer and manufacturing readiness

This integrated approach supports Accelerated Drug Development Services by allowing technical and manufacturing considerations to be addressed earlier in the development process.

For detailed process development capabilities, see Process Development.

How Drug Development Acceleration Services Reduce Delays

The development timeline can be extended by more than the laboratory work itself. Repeated experiments, late analytical development, incomplete CMC preparation, scale-up problems and technology transfer can all create additional project time.

Lianhe Aigen structures its Drug Development Acceleration Services around these potential bottlenecks.

The focus of Drug Development Acceleration is therefore to improve continuity between development stages rather than simply compressing individual laboratory activities.

Process Development for Accelerated Drug Development

Process development is one of the most important components of Accelerated Drug Development Services because process decisions made at an early stage can affect scale-up, manufacturing, analytical control and CMC requirements later.

Lianhe Aigen provides process development and optimization for APIs, intermediates, RSMs and other pharmaceutical materials across preclinical, clinical and commercial development stages.

• Route scouting and route optimization
• Reaction condition optimization
• Process robustness improvement
• Impurity control
• Residual solvent assessment
• Elemental impurity assessment
• Genotoxic impurity evaluation
• Process safety studies
• Recrystallization and crystal-form development
• Process validation and technology transfer
• Scale-up support

The process development team can work with analytical and manufacturing functions to identify potential scale-up and quality issues before they become late-stage development problems.

See Process Development for detailed process development and optimization capabilities.

Analytical Development and CMC Support

Analytical development is another important part of Drug Development Acceleration. Analytical methods, impurity profiles and quality strategies need to support process development and later manufacturing activities.

Lianhe Aigen's analytical and CMC capabilities cover:

• Analytical method development
• Analytical method optimization
• Method validation
• Impurity characterization
• Structural confirmation
• Separation and purification
• Stability studies
• Quality control strategy
• Process-related impurity assessment
• Process validation support
• CMC documentation
• Regulatory submission support

Integrating analytical development with process and manufacturing activities can reduce the risk of discovering analytical or quality issues after process scale-up.

Lianhe Aigen's CMC Service combines process, analytical, quality and regulatory activities to support pharmaceutical development programs.

Scale-Up and Technology Transfer

Moving from laboratory development to manufacturing requires more than increasing batch size. Reaction behavior, heat transfer, mixing, mass transfer, purification, equipment configuration and process safety may need to be reassessed during scale-up.

Lianhe Aigen supports development from kilo-level laboratories through pilot and cGMP manufacturing environments.

• Kilo-level laboratories
• Pilot plants
• cGMP multifunctional workshops
• Conventional reactors from 50 L to 20,000 L
• More than 1,000 conventional reactors
• Cryogenic process capabilities down to approximately −100°C
• High-temperature process capabilities up to approximately 300°C
• High-pressure hydrogenation capabilities up to 4 MPa
• Tubular and microchannel process equipment
• High-vacuum distillation

These capabilities support a more continuous transition from process development to manufacturing.

For detailed technical capabilities, see the Production Technology Platform.

Advanced Technologies for Drug Development Acceleration

Advanced production technologies can provide alternative routes for difficult chemical transformations and support process optimization.

Flow Chemistry

Flow chemistry can be applied to reactions requiring controlled reaction conditions, heat transfer or continuous processing. It can also support process intensification and scale-up strategies for selected chemical processes.

Enzyme Catalysis

Enzymatic reactions can provide selective transformation routes for appropriate substrates and may be evaluated during route development and process optimization.

Electrochemistry

Electrochemical synthesis provides an alternative approach for selected oxidation, reduction and other chemical transformations.

Photochemistry

Photochemical processes can be evaluated for transformations that are difficult to achieve efficiently through conventional reaction pathways.

Solid-State Chemistry

Crystallization and solid-state chemistry support the control of crystal form, purification and physical properties relevant to API manufacturing.

Tubular and Microchannel Technology

Tubular and microchannel equipment can support continuous processing and specific reaction conditions that benefit from enhanced heat and mass transfer.

These technologies form part of the technical foundation supporting Accelerated Drug Development Services, particularly for complex or challenging chemical processes.

CMC Planning for Faster Development

Early CMC planning can reduce the amount of technical rework required when a development program moves toward clinical and commercial manufacturing.

Lianhe Aigen supports CMC activities covering:

• Route selection and process optimization
• Critical process parameter identification
• Impurity characterization and control
• Analytical method development and validation
• Process safety evaluation
• Stability studies
• Process validation
• Manufacturing process transfer
• CMC documentation
• Regulatory submission support

The CMC strategy can be developed alongside process and analytical activities instead of being treated only as a late-stage documentation exercise.

This approach supports efforts to reduce drug development timeline by identifying manufacturing and quality requirements earlier in the program.

For the broader CMC scope, see CMC Service.

GMP Manufacturing Readiness

A development process is not complete when the laboratory process works. The process must also be suitable for controlled manufacturing and, where applicable, GMP production.

Lianhe Aigen provides manufacturing infrastructure for clinical and commercial pharmaceutical programs, including:

• GMP API manufacturing
• Process scale-up
• Technology transfer
• Manufacturing process validation
• Quality control
• Batch documentation
• Stability support
• Regulatory documentation
• Clinical supply
• Commercial manufacturing

Its API manufacturing infrastructure includes more than 500 m³ of reactor capacity across the relevant manufacturing infrastructure, supporting small molecule API production and complex chemistry programs.

The API GMP Certified Factory page provides more information about manufacturing infrastructure, quality systems and GMP capabilities.

Supporting Clinical and Commercial Development

Accelerated Drug Development Services should connect development milestones with manufacturing readiness.

Lianhe Aigen can support the transition from development into GMP manufacturing and clinical or commercial supply through:

This integrated pathway helps reduce gaps between technical development and manufacturing execution.

For outsourced manufacturing programs, see Contract API Manufacturing.

Drug Development Acceleration Across Development Stages

Lianhe Aigen's Drug Development Acceleration Services can be applied at different stages of a pharmaceutical development program.

The specific scope can be configured according to the molecule, development stage, process status, manufacturing requirements and regulatory strategy.

Integrated CRDMO Model for Drug Development Acceleration

A fragmented development model may require separate interfaces between chemistry, process development, analytical development, CMC and manufacturing providers.

An integrated CRDMO model can reduce some of these interfaces by coordinating multiple development and manufacturing functions through one platform.

The objective is not to remove necessary development work. Instead, Drug Development Acceleration Services aim to reduce avoidable repetition and delays while maintaining appropriate scientific, quality and regulatory controls.

Why Choose Lianhe Aigen for Drug Development Acceleration?

Lianhe Aigen combines pharmaceutical R&D, process development, CMC and manufacturing capabilities within an integrated CRDMO platform.

• 1,500+ employees
• 200+ scientists
• More than 25 years of experience
• Shanghai R&D center and Taizhou manufacturing platform
• Kilo-level laboratories and pilot plants
• cGMP multifunctional workshops
• 50 L–20,000 L conventional reactors
• More than 1,000 conventional reactors
• Flow chemistry, enzyme catalysis, electrochemistry and photochemistry
• Integrated analytical technology platform
• CMC and regulatory support
• GMP manufacturing capabilities
• Clinical and commercial manufacturing support

Lianhe Aigen's Quality & Compliance platform operates under an international GxP-based quality management system. Its facilities have undergone inspections and regulatory review involving authorities including FDA, NMPA, EMA, PMDA, TGA and KFDA.

Drug Development Acceleration Services vs. Individual Services

Lianhe Aigen provides several specialized pharmaceutical services. The role of this service is to connect them around the objective of accelerating development.

For API-specific production capabilities, see API Production Company.

For pharmaceutical API sourcing and supply requirements, see API Supplier for Pharma.

FAQ

What are Drug Development Acceleration Services?

Drug Development Acceleration Services integrate process development, analytical development, CMC, scale-up, manufacturing and related technical activities to reduce avoidable delays during pharmaceutical development.

How can an integrated CRDMO accelerate drug development?

An integrated CRDMO can coordinate development and manufacturing activities through one platform, reducing unnecessary handoffs and allowing process, analytical, CMC and manufacturing requirements to be considered earlier.

Can Lianhe Aigen support development through GMP manufacturing?

Yes. Lianhe Aigen supports process development, scale-up, CMC, technology transfer and GMP manufacturing, allowing development programs to transition from laboratory and pilot stages toward clinical and commercial production.

How does early CMC planning help reduce drug development timelines?

Early CMC planning can identify analytical, quality, process validation and manufacturing requirements before later development stages. This can reduce the need for additional technical work when a program approaches GMP manufacturing or regulatory submission.

Does Lianhe Aigen provide process development services?

Yes. Process development covers route scouting, optimization, impurity control, process safety, crystallization, scale-up, validation and technology transfer. Detailed capabilities are available through Process Development.

Can Lianhe Aigen support clinical and commercial API manufacturing?

Yes. Lianhe Aigen provides API manufacturing capabilities for clinical and commercial programs, supported by process development, scale-up, GMP manufacturing, analytical and CMC capabilities.