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

Appearance

Purity and contents

HPLC purity (superhelix)

Contents (Ultraviolet/fluorescent contents)

Purity of agarose

UV purityA260/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

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

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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