Cell CDMO Solution

As your cell therapy products (e.g., CAR-T, TCR-T, CAR-NK) progress into clinical stages, higher demands are placed on process stability, product consistency, and production scale. By optimizing process parameters and strengthening quality systems, we ensure the provision of high-quality, reproducible cell products for pivotal clinical studies (Phase II/III). We effectively manage the complexity of personalized medicines and meet the stringent consistency requirements of multi-center clinical trials.

Services

*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services. 

Advantages

Advantages of using our HiCellx® technology platform:

• Using independently developed cryopreserved cell preparation

• Using closed and automated cell culturing equipment, the same as the global mainstream companies

• Cell workshop compliant with clinical and commercial requirements: grades B+A, unidirectional air flow, Full-GMP

• Cell proliferation with higher rate, solved the issues of low positive rate and proliferation rate

• Flexibly suitable for manufacturing and testing of various cellular therapy products

• Extensive experience in using the closed and automated cell culturing equipment

• Experience in manufacturing of 200+ IIT clinical samples

• Experience in IND submission of a CAR-NK cell product, which was successfully approved by NMPA

• Experience in supporting the technology transfer of clinical batch of CAR-NK cell products and in manufacturing of cell samples for clinical use

Manufacturing Process

Quality Control

*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items. 

Project Timeline

Project Management Plan

Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.

In anticipation of diversified cell therapy commercialization, Hillgene has built a Commercial-level cell production platform renowned for its scalability, cost-efficiency, and reliability. We tackle core challenges in commercialization such as scalable production, cost control, and global supply chain stability for therapies like CAR-T and TCR-T. Through highly automated closed production systems and lean operations management, we achieve end-to-end scalable, low-cost commercial production—from patient cell collection to final product filling—ensuring every batch meets global regulatory standards.

Services

*Note: We offer relatively flexible and customized changes to above services, including but not limited to above services. 

Advantages

Advantages of using our HiCellx^® technology platform:

• Using independently developed cryopreserved cell preparation

• Using closed and automated cell culturing equipment, the same as the global mainstream companies

• Cell workshop compliant with clinical and commercial requirements: grades B+A, unidirectional air flow, Full-GMP

• Cell proliferation with higher rate, solved the issues of low positive rate and proliferation rate

• Flexibly suitable for manufacturing and testing of various cellular therapy products

• Extensive experience in using the closed and automated cell culturing equipment

• Experience in manufacturing of 200+ IIT clinical samples

• Experience in IND submission of a cell therapy product, which was successfully approved by NMPA

• Experience in supporting the technology transfer of commercial batch production of a cell therapy product and in manufacturing of cell samples for clinical use

Manufacturing Process

Quality Control

*Note: Hillgene established QC methods corresponding to different technology platforms, with QC methods including but not limited to above items. 

Project Timeline

Project Management Plan

Hillgene Project Management Team, consisting of chief scientists, project managers, Project QA and GMP experts, will make efforts to ensure the smooth and sound operation of each and every GMP project.