CDMO Solutions for CAR-T

Lentivirus, a subtype of retrovirus, can integrate the target gene into the host cell genome, and is commonly used as a viral vector for ex vivo cell engineering. With the emergence of cellular therapy industry, the market demands for lentiviral vectors are also increasing with each passing year. Hillgene is specialized in provision of integrated CDMO solutions for cellular therapy products, has established an advanced GMP grade platform for serum-free suspension culturing of lentiviral vectors, and therefore, can provide high-quality CDMO services for lentiviral vectors to clients with various demands.

Services

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

Advantages

Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:

• Free of animal-derived components throughout the process

• Linearly scaled up production of lentiviral vectors

• Using a single container of a 50 L disposable bioreactor

• Cell bank creation in separate workshops

• Dispensing final products using a sterile isolator

• Dedicated lentivirus system for CAR-T cells, with high infection efficiency

• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)

• Several successful IND submissions to NMPA of lentiviral vectors for CAR-T cells

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.

Lentivirus, a subtype of retrovirus, can integrate the target gene into the host cell genome, and is commonly used as a viral vector for ex vivo cell engineering. With the emergence of cellular therapy industry, the market demands for lentiviral vectors are also increasing with each passing year. Hillgene is specialized in provision of integrated CDMO solutions for cellular therapy products, has established an advanced GMP grade platform for serum-free suspension culturing of lentiviral vectors, and therefore, can provide high-quality CDMO services for lentiviral vectors to clients with various demands.

Services

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

Advantages

Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:

• Free of animal-derived components throughout the process

• Linearly scaled up production of lentiviral vectors

• Using a single container of a 50 L disposable bioreactor

• Cell bank creation in separate workshops

• Dispensing final products using a sterile isolator

• Dedicated lentivirus system for CAR-T cells, with high infection efficiency

• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)

• Several successful IND submissions to NMPA of lentiviral vectors for CAR-T cells

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.

Lentivirus, a subtype of retrovirus, can integrate the target gene into the host cell genome, and is commonly used as a viral vector for ex vivo cell engineering. With the emergence of cellular therapy industry, the market demands for lentiviral vectors are also increasing with each passing year. Hillgene is specialized in provision of integrated CDMO solutions for cellular therapy products, has established an advanced GMP grade platform for serum-free suspension culturing of lentiviral vectors, and therefore, can provide high-quality CDMO services for lentiviral vectors to clients with various demands.

Services

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

Advantages

Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:

• Free of animal-derived components throughout the process

• Linearly scaled up production of lentiviral vectors

• Using a single container of a 50 L disposable bioreactor

• Cell bank creation in separate workshops

• Dispensing final products using a sterile isolator

• Dedicated lentivirus system for CAR-T cells, with high infection efficiency

• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)

• Several successful IND submissions to NMPA of lentiviral vectors for CAR-T cells

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.

Lentivirus, a subtype of retrovirus, can integrate the target gene into the host cell genome, and is commonly used as a viral vector for ex vivo cell engineering. With the emergence of cellular therapy industry, the market demands for lentiviral vectors are also increasing with each passing year. Hillgene is specialized in provision of integrated CDMO solutions for cellular therapy products, has established an advanced GMP grade platform for serum-free suspension culturing of lentiviral vectors, and therefore, can provide high-quality CDMO services for lentiviral vectors to clients with various demands.

Services

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

Advantages

Advantages of using our platform for serum-free suspension culturing of lentiviral vectors:

• Free of animal-derived components throughout the process

• Linearly scaled up production of lentiviral vectors

• Using a single container of a 50 L disposable bioreactor

• Cell bank creation in separate workshops

• Dispensing final products using a sterile isolator

• Dedicated lentivirus system for CAR-T cells, with high infection efficiency

• Low production costs and testing costs (no requirements of testing for BSA and residual pancreatic enzymes)

• Several successful IND submissions to NMPA of lentiviral vectors for CAR-T cells

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.

Manufacturing of plasmids, a critical step of manufacturing CAR-T cellular therapy products, involves a series of complicated processes of manufacturing, purification, and analysis. As essential tools for genetic engineering, bacterial plasmids can not only be used as final products for gene and cellular therapy, but also as intermediate vectors for the manufacturing of gene and cell therapy products, and are inevitably used in manufacturing steps for most gene and cellular therapy products. With the emergence of the cellular therapy industry, the market demands for plasmids are also increasing with each passing year. Hillgene is specialized in the provision of integrated CDMO solutions for cellular therapy products, has established a GMP manufacturing platform for nucleic acid products, and therefore, can provide high-quality CDMO services for plasmids to clients with various demands.

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 with kanamycin-resistance gene

• A system with the capability of sustained optimization

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

• Extensive experience in successful IND submissions

• CAR-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.

Manufacturing of plasmids, a critical step of manufacturing CAR-T cellular therapy products, involves a series of complicated processes of manufacturing, purification, and analysis. As essential tools for genetic engineering, bacterial plasmids can not only be used as final products for gene and cellular therapy, but also as intermediate vectors for the manufacturing of gene and cell therapy products, and are inevitably used in manufacturing steps for most gene and cellular therapy products. With the emergence of the cellular therapy industry, the market demands for plasmids are also increasing with each passing year. Hillgene is specialized in the provision of integrated CDMO solutions for cellular therapy products, has established a GMP manufacturing platform for nucleic acid products, and therefore, can provide high-quality CDMO services for plasmids to clients with various demands.

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 with kanamycin-resistance gene

• A system with the capability of sustained optimization

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

• Extensive experience in successful IND submissions

• CAR-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.

Manufacturing of plasmids, a critical step of manufacturing CAR-T cellular therapy products, involves a series of complicated processes of manufacturing, purification, and analysis. As essential tools for genetic engineering, bacterial plasmids can not only be used as final products for gene and cellular therapy, but also as intermediate vectors for the manufacturing of gene and cell therapy products, and are inevitably used in manufacturing steps for most gene and cellular therapy products. With the emergence of the cellular therapy industry, the market demands for plasmids are also increasing with each passing year. Hillgene is specialized in the provision of integrated CDMO solutions for cellular therapy products, has established a GMP manufacturing platform for nucleic acid products, and therefore, can provide high-quality CDMO services for plasmids to clients with various demands.

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 with kanamycin-resistance gene

• A system with the capability of sustained optimization

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

• Extensive experience in successful IND submissions

• CAR-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.

Manufacturing of plasmids, a critical step of manufacturing CAR-T cellular therapy products, involves a series of complicated processes of manufacturing, purification, and analysis. As essential tools for genetic engineering, bacterial plasmids can not only be used as final products for gene and cellular therapy, but also as intermediate vectors for the manufacturing of gene and cell therapy products, and are inevitably used in manufacturing steps for most gene and cellular therapy products. With the emergence of the cellular therapy industry, the market demands for plasmids are also increasing with each passing year. Hillgene is specialized in the provision of integrated CDMO solutions for cellular therapy products, has established a GMP manufacturing platform for nucleic acid products, and therefore, can provide high-quality CDMO services for plasmids to clients with various demands.

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 with kanamycin-resistance gene

• A system with the capability of sustained optimization

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

• Extensive experience in successful IND submissions

• CAR-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.