CDMO-浦珠生物

CRO

Introduction:

In recent years, with the launch of gene therapy and CAR-T, emerging potential candidate products have been developed. For these candidate products to enter clinical research stage (IND application) or marketing stage (BLA application), they are required to establish corresponding intermediate and production processing controls, product release test methods according to ICH guidelines. Pracgen is equipped with world-class analysis and testing platform for plasmids, lentivirus vectors and CAR-T cells, including microbial, biological activity, qPCR/ELISA/HPLC. This can fulfill the technical requirements for IND and NDA applications, which accelerates development of gene therapy and CAR T-cell therapy products.

Procedure:

1. In-vivo and in-vitro pharmacodynamics evaluations：

（1）Cytotoxic activity of in vitro CAR T-cells

（2）Analysis of CAR T-cell cytokines

2. Methods development, validation, and release test for plasmid detection：

Testing category	Testing items	Batch release testing	Stability
Routine	pH	√	√
Routine	Appearance	√	√
Purity and contents	HPLC purity (superhelix)	√	√
	Contents (Ultraviolet/fluorescent contents)	√	√
	Purity of agarose	√	√
	UV purity（A260/A280;A230/A260）	√	√
Identification	DNA sequencing	√	NA
	Identification of restriction endonuclease spectrum	√	√
	Identification of agarose	√	√
Impurity	Host protein residues	√	NA
	Host DNA residues	√	NA
	RNA residues	√	NA
	Antibiotic residues	√	NA
Safety	Endotoxin	√	NA
Safety	Sterility	√	√

3. Methods development, validation and release test for lentivirus：

Testing category	Testing items	Batch release testing	Stability
Routine	pH	√	√
	Appearance	√	√
	Osmotic pressure	√	√
Purity and contents	Integration titer	√	NA
	Infection titer	√	√
	Physical titer	√	√
	Total protein content	√	√
Identification	Objective sequencing	√	NA
Impurities	Bovine serum albumin residues	√	NA
	Host protein residues	√	NA
	Nuclease residues	√	NA
	Protease residues	√	NA
	Host DNA residues	√	NA
	Plasmid residues	√	NA
	Copy number of SV40 gene	√	NA
	Copy number of EIA gene	√	NA
Safety	Bacterial endotoxins	√	NA
	Mycoplasma	√	NA
	Sterility test	√	√
	RCL (QPCR or co-culture)	√	√

4. Methods development, validation and release test for CAR T-cell products：

Testing category	Testing items	Batch release testing	Stability
Routine	Appearance	√	√
	Load capacity	√	√
	pH	√	√
	Osmotic pressure	√	√
Purity and content	Cell viability and density	√	√
	T-cell phenotype ratio	√	√
	CAR positive rate	√	√
Identification	Copy number of virus vectors	√	NA
Identification	CAR identification	√	NA
Biological activity	Cell lethality	√	√
Impurities	Magnetic bead residues	√	NA
	Impure cell residues	√	NA
	Cytokine residues	√	NA
	Protein residues	√	NA
	gRNA residues	√	NA

5. Stability studies：

(1) Long-term stability studies

(2) Simulated transportation stability studies

(3) Accelerated stability studies

(4) Compulsory stability studies and other studies

Advantages:

Established platform

Microbial Detection
Biological Activity Detection Platform
FACS/qPCR/ELISA/HPLC
Well proven methods

Methods for detecting & analyzing plasmid
Methods for detecting & analyzing lentivirus vector
Methods for detecting & analyzing CAR T-cell therapy products
RCL (co-culture) methods for lentivirus vectors and CAR T-cell products
Follow-up RCL monitoring of patients’ CAR T-cells
Well-experienced team

Rich working experience with large biomedical companies
Experience in developing innovative gene therapy products
Experience with successful IND applications in China and the United States

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