CDMO

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.

As your project advances to pivotal clinical stages, we scale up and optimize processes to ensure the supply of large-volume, highly consistent plasmid materials for global multi-center Phase II/III trials. We focus on inter-batch quality stability and reproducibility, implementing stricter release standards to guarantee medication safety and supply continuity throughout long-term clinical studies, thereby providing solid data support for market approval.

Services

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

Advantages

Advantages of our plasmid system:

• An independently developed four-plasmid system 

• A system with the capability of sustained optimization

• Plasmid sequences are traceable, compliant with requirements, and efficient

• Extensive experience in successful IND submissions

• TCR-T cell samples for clinical use are currently manufacturing and in use

• 2-5 folds higher titers after using our plasmid system from the comparison in several projects

Advantages of our plasmid manufacturing:

• Free of antibiotics throughout the manufacturing process

• Plasmid production and bank creation in separate workshops

• Complete isolation between non-sterile and sterile areas

• Dispensing final products using an isolator

• Completed CTD dossiers for packaging plasmid (for lentiviral vector), reducing the submission preparation time by 3-4 months, with INDs of a few products granted preliminary approval and currently in phase I of clinical study

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.

Services

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

Advantages

Advantages of our plasmid system:

• An independently developed four-plasmid system 

• A system with the capability of sustained optimization

• Plasmid sequences are traceable, compliant with requirements, and efficient

• Extensive experience in successful IND submissions

• TCR-T cell samples for clinical use are currently manufacturing and in use

• 2-5 folds higher titers after using our plasmid system from the comparison in several projects

Advantages of our plasmid manufacturing:

• Free of antibiotics throughout the manufacturing process

• Plasmid production and bank creation in separate workshops

• Complete isolation between non-sterile and sterile areas

• Dispensing final products using an isolator

• Completed CTD dossiers for packaging plasmid (for lentiviral vector), reducing the submission preparation time by 3-4 months, with INDs of a few products granted preliminary approval and currently in phase I of clinical study

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.