ADC CDMO Services – Integrated Development & Manufacturing Partner

ADC CDMO Services for Global Pharmaceutical Companies

As a Manufacturer & Solution Provider, Lianhe Aigen delivers ADC CDMO Services under a customized, NDA-based collaboration model, supporting global pharmaceutical companies from preclinical development to commercial manufacturing.

Backed by established manufacturing infrastructure and integrated CRDMO capabilities, we provide scalable, regulatory-aligned, and risk-controlled solutions for complex ADC projects.

What We Offer

Our ADC CDMO Services are designed to support the full lifecycle of antibody-drug conjugate development, combining process development, scale-up, and manufacturing within a unified system.

We work closely with global pharmaceutical partners under strict confidentiality, delivering solutions that are:

• Scalable from early development to commercial supply
• Aligned with global regulatory expectations
• Structured for reproducibility and long-term delivery

ADC CDMO Capabilities

We provide integrated capabilities to support the development and manufacturing of complex ADC molecules:

• Process development and optimization to enable reproducible and scalable manufacturing
• Scale-up capability from laboratory to commercial production
• Consistent and controlled manufacturing processes to ensure batch reproducibility
• Support for complex ADC structures, enabling reliable production across development stages

Our focus is on delivering robust, scalable, and process-driven ADC manufacturing solutions, rather than isolated technical services.

ADC Services by Development Stage

Preclinical ADC Supply

• Early-stage process development support
• Small-scale, reproducible ADC production
• Preparation for IND-enabling activities

Clinical-Stage ADC Manufacturing

• Controlled and consistent manufacturing processes
• Support for clinical trial material supply
• Process robustness aligned with regulatory expectations

Commercial ADC Production

• Scalable manufacturing capability
• Long-term supply assurance
• Stable and reproducible commercial production systems

Integrated CRDMO Capability

Lianhe Aigen provides end-to-end integration across the ADC value chain, enabling efficient project execution:

• From intermediates to API manufacturing
• Integrated development and production platform
• Seamless transition from process development to commercial supply

This integrated approach reduces technical risk, improves efficiency, and supports long-term project continuity.

Our ADC CDMO Services Include:

• Antibody Production: Advanced cell culture and purification technologies ensure high-quality antibody manufacturing.
• Linker Synthesis: Multiple linker chemistries tailored to your ADC design for optimal stability and efficacy.
• Payload Manufacturing: Support for diverse cytotoxic payload synthesis under strict GMP compliance.
• Conjugation & Purification: Optimized conjugation methods and downstream purification to maximize drug-to-antibody ratio (DAR) and reduce impurities.
• Analytical Method Development: Robust analytical testing including DAR, free payload, and stability assessment to ensure batch-to-batch consistency.
• Fill & Finish: Specialized fill–finish and lyophilization for ADCs to maintain potency and product stability throughout the supply chain.

Quality & Compliance

Our ADC CDMO Services are supported by a comprehensive quality system aligned with global pharmaceutical standards:

• Manufacturing under a cGMP-compliant quality system
• Quality management aligned with international regulatory expectations
• Full traceability of materials, intermediates, and processes
• Structured systems for change control and deviation management
• Support for regulatory submissions and customer audits

Our goal is to ensure every project is audit-ready, compliant, and suitable for global pharmaceutical markets.

How We Work

We follow a structured, transparent approach to ADC CDMO collaboration:

1. NDA-based project onboarding
2. Technical evaluation and feasibility assessment
3. Process development and optimization
4. Scale-up and manufacturing
5. Delivery and long-term supply support

This model ensures confidentiality, clarity, and controlled execution throughout the project lifecycle.

Why Partner With Lianhe Aigen

As a trusted ADC CDMO partner, Lianhe Aigen combines:

• Technology & Innovation
  Continuous focus on process development and scalable solutions
• Process Development Expertise
  Strong capability in route design, optimization, and scale-up
• Project Management Capability
  Structured execution to ensure timelines, coordination, and risk control
• Compliance Support
  Alignment with global regulatory requirements and audit expectations
• Quality Management System
  Established system ensuring consistency, traceability, and reliability

Backed by Lianhe Tech’s long-standing manufacturing foundation, we offer a stable, scalable, and long-term partnership model for global pharmaceutical companies.

Who We Serve

We provide ADC CDMO Services to pharmaceutical companies across:

• United States
• Europe
• Japan

Supporting:

• Global pharmaceutical companies
• Biotechnology companies
• Emerging biotech innovators

Our focus is on building long-term, high-trust partnerships with companies developing innovative therapies.

Start Your ADC CDMO Project

Partner with a reliable ADC CDMO Services provider for integrated development and manufacturing.

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