CDMO Services for Plasmids-IIT grade/non-clinical phase

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

CDMO Services for Plasmids
Types			Services
IIT grade	1	Independently developed four-plasmid system	●　Third generation four-plasmid system ●　Kanamycin-resistance gene ●　No patent license required	●　Seamless connection to IND submission ●　GMP-like workshop ●　GMP-like quality management system ●　Authentic and traceable documentation
	2	Creation of bacteria bank (GMP-like)	●　Tailorable number and specification of bacteria banks to be created
	3	Plasmid Manufacturing and Testing (GMP-like)	●　Tailorable production output and specification

*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

Test Item		Test Method
Appearance		Visual inspection
Identification	Identification 1	Restriction mapping
Identification	Identification 2	Sanger sequencing
Test	pH	Method 0631 of ChP 2020
	Purity	High performance liquid chromatography (HPLC)
	Residual E.coli host cell protein	ELISA
	Residual E.coli DNA	q-PCR
	Residual E.coli RNA	q-PCR
	Residual antibiotics	ELISA
	Endotoxin	Method 1143 of ChP 2020
	Sterility	Method 1101 of ChP 2020
Concentration determination	DNA concentration	Method 0401 of ChP 2020

*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.

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