Hieff Trans PEI Transfection Reagents—R&D and GMP Grade for Viral Vector Production

Cell therapy refers to the use of biotechnology methods to obtain cells with specific functions, which are then enhanced through processes such as ex vivo expansion and specialized cultivation. These cells are endowed with augmented immune responses, pathogen and tumor cell killing capabilities, and other functions to achieve the therapeutic goals for certain diseases. Gene therapy refers to the therapeutic approach of modifying individual gene expression or repairing defective genes through methods such as gene addition, gene modification, and gene silencing. The ultimate aim is to cure diseases by rectifying abnormal genes.

Product Types

Description

Number of Approved Drugs Worldwide

Gene Therapy Vector Products

These products utilize gene therapy vectors to deliver therapeutic genes to specific cells in the patient's tissues, aiming for the expression or regulation of therapeutic proteins. This category relies on the delivery of gene therapy vectors.

2

Cellular Products

Using integrating viral vectors (such as lentiviral vectors), genes are introduced into precursor cells or stem cell genomes under ex vivo conditions. As cells divide, the genes are passed to descendant cells. The modified cells are then infused back into the patient. Cellular products mainly include categories such as T cells, NK cells, and stem cells.

8

Oncolytic Virus Products

Derived from modified oncolytic viruses with tumor-killing capabilities, these products work on the principle of utilizing the virus's specific recognition of tumor cells and the immune activation triggered upon infecting tumor cells. This leads to targeted killing of tumor cells.

1

 

Viral Vector Production and Expression Solution

The core of Cell and Gene Therapy (CGT) drug production lies in the expression of viral vectors, a process that typically involves both upstream vector expression and downstream purification. Vector production involves highly complex processes, presents significant challenges, and often has long preparation cycles. Consequently, the global GMP production capacity for viral vectors is approaching a bottleneck, posing a major obstacle to the entire gene therapy industry's development. The development, scale-up, and GMP production of gene therapy vectors involve intricate production systems and stringent quality control systems. These encompass processes such as strain, cell, and virus banks establishment, large-scale E. coli fermentation, cell culture processes, virus harvest and purification processes, aseptic processing, and formulation and filling processes.

AAV Production Costs

Apart from fixed asset investments (such as equipment, cleanrooms, etc.) and labor costs, the main expenses arise from material consumption in the upstream and downstream processes. Upstream costs mainly involve raw materials like plasmids, culture media, transfection reagents, and nucleases; downstream costs mainly include chromatography resins, quality control expenses, and more.

Cationic Polymer Carrier

Cationic polymers (polymers) include polyethylenimine (PEI), poly(beta-amino ester) (PBAE), chitosan, polyacrylamide (PAH), diethylaminoethyl dextran (DEAE-dextran), poly(amidoamine) dendrimers (PAMAM), and others. The common principle of cationic polymer transfection involves complexing DNA under physiological pH conditions to prevent degradation by DNase. Subsequently, these complexes attach to the cell membrane and are taken up by endocytosis, followed by rupture and release of DNA into the cytoplasm to exert their intended functions. The primary distinction between cationic polymers and cationic lipids lies in the absence of hydrophobic portions in cationic polymers, making them completely water-soluble and allowing for convenient chemical modifications.

 

Hieff Trans® PEI Transfection Reagents

Test Item Standard R&D Grade
40820
GMP Grade
40821
Appearance Complete, accurate information, no damage, etc
Transfection efficiency > 70% Transfection efficiency> 80% Cell viability
Endotoxin  0.5 EU/mL
Sterility Aseptic growth
Mycoplasma Residue Negative
pH < 7.0  
Osmotic Pressure  30 mOsm/kg  
Impurity Residue Methanol(≤ 0.3% Ethyl ether(≤ 0.5% Methylbenzene(≤ 0.002%  
Heavy Metal Residue ≤ 10 ppm

 

 Transfection of Single Plasmid

Virus Titer Data 

1. LV Production

2. AAV2 Production

3. AAV5 Production

 

 4. RV Production

 Product Information

Product Name Cat No.
Hieff Trans® PEI Transfection Reagent-GMP 40821ES
E.coli Host Cell DNA Residue Detection Kit  41308ES
E.coli Host Cell RNA Residue Detection Kit 41318ES
E.coli HCP ELISA kit  36712ES
HEK293 HCP ELISA kit 36713ES
HEK293 Host Cell DNA Residue Detection Kit 41302ES
HEK293 Host Cell Residue DNA Size Analysis Kit 41316ES
MycAway™ Mycoplasma Real-time qPCR Detection Kit (2G) 40619ES
UCF.ME® UltraNuclease GMP-grade   20157ES
Salt Active UltraNuclease GMP-grade 20159ES
UltraNuclease ELISA Kit  36701ES
Salt Active UltraNuclease ELISA Kit  36703ES
RCA (E1A) Copy number Detection Kit  41321ES
Replication-competent Lentivirus (RCL) Detection Kit  41311ES
MolPure™ Magnetic Residual DNA Sample Preparation Kit 18461ES

 

BenzonaseLinear peiPei transfection reagentTransfection reagentsViral vector