Lianhe Aigen is a leading Contract Manufacturing Organization (CMO), offering comprehensive solutions for the development and manufacturing of innovative drugs at every stage of the lifecycle—from preclinical to commercial production. Our state-of-the-art facilities, combined with our technical expertise and rigorous quality standards, allow us to support pharmaceutical companies in efficiently scaling their production while maintaining the highest standards of quality, compliance, and safety.

Why Choose Our CMO Services?

With a proven track record of successful collaborations with global pharmaceutical companies, Lianhe Aigen is your trusted partner for integrated manufacturing services. Our facilities are inspected and approved by regulatory bodies such as the FDA, EMA, PMDA, TGA, KFDA, and NMPA, ensuring that your products are developed and manufactured to meet the highest international standards. Whether you are developing small molecules, peptides, biologics, or specialized drug delivery systems, we provide end-to-end solutions to support your drug development and commercialization needs.

Key Features of Our CMO Services:

1. Comprehensive Drug Manufacturing Support:

Preclinical to Commercial Manufacturing: We offer scalable manufacturing solutions from early-stage clinical trials to large-scale commercial production.

Flexible Production Options: Tailored manufacturing solutions that meet the specific needs of each project, whether it's for small batches or large-scale production runs.

2. State-of-the-Art Manufacturing Platforms:

Flow Chemistry Platform: For efficient and scalable synthesis of complex molecules.

Solid-State Chemistry Platform: Optimizing crystalline forms and polymorphs for drug stability and performance.

Amino Acid & Peptide Platform: Specialized facilities for peptide synthesis and optimization.

ADC/PROTAC Linker Platform: Advanced manufacturing capabilities for the development of antibody-drug conjugates and PROTACs.

Oligonucleotide Platform: Leading-edge technology for oligonucleotide synthesis and production.

3. Rigorous Quality Assurance and Control:

A robust, fully integrated Quality Management System (QMS) to ensure that all products meet global regulatory standards.

Extensive in-process controls and post-manufacturing testing to ensure consistency, safety, and efficacy.

Full analytical support, including stability testing, release testing, and final batch approval.

4. Global Regulatory Compliance:

Our manufacturing facilities are compliant with all major regulatory agencies, including the FDA, EMA, PMDA, TGA, KFDA, and NMPA.

We provide full regulatory support throughout the manufacturing process, including the preparation of documentation for regulatory submissions and inspections.

Experienced in preparing for and passing routine inspections from international regulatory bodies.

5. Customizable Manufacturing Solutions:

Scale-up & Technology Transfer: Efficient scale-up services from preclinical studies to clinical trials and large-scale commercial production.

Process Development and Optimization: We work closely with clients to optimize production processes, improve yields, reduce costs, and ensure the scalability of manufacturing processes.

Supply Chain Management: Comprehensive supply chain solutions to ensure on-time delivery of raw materials, intermediates, and final products to meet your timelines.

6. Sustainability and Safety:

Commitment to high safety standards and environmentally responsible manufacturing practices.

Continuous improvement of operational efficiency and environmental protection measures to reduce waste and ensure sustainability.

Streamlining the Path from Drug Development to Commercialization

Lianhe Aigen is dedicated to supporting the global pharmaceutical industry with reliable, efficient, and flexible manufacturing solutions. By combining advanced technologies with a customer-centric approach, we help you accelerate the transition from preclinical to commercial drug production, ensuring that your products are manufactured with the highest standards of quality, consistency, and compliance.

Partner with Lianhe Aigen for end-to-end CMO services that support the successful commercialization of your innovative drugs. Whether you need small molecule manufacturing, biologics production, or specialized drug formulations, our integrated capabilities ensure the smooth transition from development to market.