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Preclinical CMC Research

———— Cell Line Construction & GMP Cell Building

Core Advantages

The average yield of cell line construction can reach3-5g/L

Ideally>6g/L

  • Gene sequence optimization: codon optimization, expression vector screening, signal peptide screening, etc
  • Signal peptide screening and other different host cells and carrier systems: cho-k1/s/k1q, etc., with clear cell sources, strong adaptability and good stability
  • A round of limited dilution method and monoclonal imager imaging are used to screen monoclonal antibodies and provide evidence of monoclonal source
  • Achieve stable passage of cell lines above 60PDL
  • The construction process and records of cell lines in line with the declaration of China and the United States
  • With a platform cell line construction process, it can achieve efficient development and obtain stable and high-yield cell lines

Service Content

Host Cell

The company has various types of host cells, with clear cell sources and no pollution. It provides a variety of options to express foreign proteins and process optimization

Plasmid

Plasmid construction (outsourcing): integrate foreign genes into the plasmid skeleton for the expression of target genes in cells. The company can provide multiple plasmid skeleton selection, different pressure screening systems, and optimize plasmid elements and foreign target genes. The plasmid expression performance was tested and compared by transient or large pool.

Transfection

It can be divided into transient transfection and stable transfection. The main methods are liposome transfection and electrotransfection. Objective to introduce foreign DNA fragments into cells under certain conditions to obtain a new phenotype and release the target protein to the outside of the cell. A large number of cell transfection experiments can be carried out in the laboratory, and the target protein can be quickly obtained by transient transfection or the stable protein secreting monoclonal cell line can be obtained by pressurization.

Construction of high-yield stable cell line

The plasmid was introduced into the host cell by transfection and integrated into the chromosome. The cell line was screened with the corresponding resistance markers in the plasmid DNA. A series of screening criteria and mechanisms were used to obtain a high-yield cell line and expand it. Finally, monoclonal cell lines were prepared to obtain highly secreted foreign protein cell lines with stable properties. At present, the stable cell line of platform technology can reach >4g/L.

Monoclonal

The positive cell group obtained after transfection can be separated into single cells by limited dilution method or modern machine and grow, which can obtain high-yield positive cell lines and eliminate non expressing or low expressing cells, and the single cell group has high stability. During the experiment, a monoclonal imager was used for the whole process of tracking, photographing and imaging, and a monoclonal report was issued to ensure the accuracy of the experiment.

Cell line stability

The stability of high-yield monoclonal cell lines was tested, and the cells were subcultured for more than 40 generations. The growth and metabolism of cells were compared, and the amount of protein secretion and protein quality were considered. Now it can be stably passed on for more than 40 generations.

Core Advantages

Cell bank building Core Advantages

  • cGMP-compliant cell banking services that meet multi-country application requirements are provided, including MCB/WCB, etc.
  • Dynamic environmental monitoring of cell recovery and freeze-thawing operations to confirm the environmental compliance of the banking operations.
  • The advanced CryoMed automatic programmable cooling equipment is adopted for cell freeze-thawing and storage, with large capacity, high performance, safety and reliability.
  • he cell bank adopts gas phase storage, equipped with an online temperature monitoring system and a liquid nitrogen liquid level monitoring system, where liquid nitrogen is automatically replenished, and storage is safe and reliable.
  • After the completion of the cell bank establishment, the cell bank identification is performed according to the GMP requirements, such as cell identification, bacteria and fungi inspection, mycobacteria inspection, mycoplasma inspection, internal and exogenous viral factor inspection, etc.
  • Level-to-level and classified methods are adopted for cell bank management to avoid risk of cross-contamination and ensure the safety of customers’ cell lines

Service Content

Preclinical CMC Research

———— Cell Line Construction & GMP Cell Building

Core Advantages

The average yield of cell line construction can reach3-5g/L

Ideally>6g/L

  • Gene sequence optimization: codon optimization, expression vector screening, signal peptide screening, etc
  • Signal peptide screening and other different host cells and carrier systems: cho-k1/s/k1q, etc., with clear cell sources, strong adaptability and good stability
  • A round of limited dilution method and monoclonal imager imaging are used to screen monoclonal antibodies and provide evidence of monoclonal source
  • Achieve stable passage of cell lines above 60PDL
  • The construction process and records of cell lines in line with the declaration of China and the United States
  • With a platform cell line construction process, it can achieve efficient development and obtain stable and high-yield cell lines

Service Content

Host Cell

The company has various types of host cells, with clear cell sources and no pollution. It provides a variety of options to express foreign proteins and process optimization

Plasmid

Plasmid construction (outsourcing): integrate foreign genes into the plasmid skeleton for the expression of target genes in cells. The company can provide multiple plasmid skeleton selection, different pressure screening systems, and optimize plasmid elements and foreign target genes. The plasmid expression performance was tested and compared by transient or large pool.

Transfection

It can be divided into transient transfection and stable transfection. The main methods are liposome transfection and electrotransfection. Objective to introduce foreign DNA fragments into cells under certain conditions to obtain a new phenotype and release the target protein to the outside of the cell. A large number of cell transfection experiments can be carried out in the laboratory, and the target protein can be quickly obtained by transient transfection or the stable protein secreting monoclonal cell line can be obtained by pressurization.

Construction of high-yield stable cell line

The plasmid was introduced into the host cell by transfection and integrated into the chromosome. The cell line was screened with the corresponding resistance markers in the plasmid DNA. A series of screening criteria and mechanisms were used to obtain a high-yield cell line and expand it. Finally, monoclonal cell lines were prepared to obtain highly secreted foreign protein cell lines with stable properties. At present, the stable cell line of platform technology can reach >4g/L.

Monoclonal

The positive cell group obtained after transfection can be separated into single cells by limited dilution method or modern machine and grow, which can obtain high-yield positive cell lines and eliminate non expressing or low expressing cells, and the single cell group has high stability. During the experiment, a monoclonal imager was used for the whole process of tracking, photographing and imaging, and a monoclonal report was issued to ensure the accuracy of the experiment.

Cell line stability

The stability of high-yield monoclonal cell lines was tested, and the cells were subcultured for more than 40 generations. The growth and metabolism of cells were compared, and the amount of protein secretion and protein quality were considered. Now it can be stably passed on for more than 40 generations.

Core Advantages

Cell bank building Core Advantages

  • cGMP-compliant cell banking services that meet multi-country application requirements are provided, including MCB/WCB, etc.
  • Dynamic environmental monitoring of cell recovery and freeze-thawing operations to confirm the environmental compliance of the banking operations.
  • The advanced CryoMed automatic programmable cooling equipment is adopted for cell freeze-thawing and storage, with large capacity, high performance, safety and reliability.
  • he cell bank adopts gas phase storage, equipped with an online temperature monitoring system and a liquid nitrogen liquid level monitoring system, where liquid nitrogen is automatically replenished, and storage is safe and reliable.
  • After the completion of the cell bank establishment, the cell bank identification is performed according to the GMP requirements, such as cell identification, bacteria and fungi inspection, mycobacteria inspection, mycoplasma inspection, internal and exogenous viral factor inspection, etc.
  • Level-to-level and classified methods are adopted for cell bank management to avoid risk of cross-contamination and ensure the safety of customers’ cell lines

Service Content

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