Monoclonal Cell Line Optimization for Antibody Production

Pre-Production Verification

In order to provide maximum antibody yield during production, SDIX examines the viability of your cell line and the clonality of your cell line through limited dilution cloning. Clonality is the determination of the fraction of cells secreting antibody in a culture.

By evaluating these parameters upfront, allows for maximum antibody generation during production which ultimately results in a lower price per milligram.

Each cell line is evaluated in four steps:

Monoclonal Cell Line Optimization for Antibody Production steps

The Process

Step 1 – Biological Testing

Evaluate cell lines for presence of murine viruses or mycolplasma

Biological Safety Testing Options:

Impact I

• Mycoplasma app.
• Mycoplasma pulmonis
• Sendai virus
• Mouse hepatits virus
• Pneumonia virus of mouse
• Minute virus
• Mouse parvovirus (MPV1-5)
• Theiler’s murine encephalomyelitis virus
• Murine Norovirus
• Reovirus 3

• Ectomelia virus
• Lymphocytic choriomeningitis virus
• Polyoma virus
• Lactate dehydrogenase-elevating virus
• Mouse adenovirus
• Mouse cytomegalovirus
• K virus
• Mouse thymic virus
• Hantaan virus

Impact IV

• Mycoplasma app.
• Mycoplasma pulmonis
• Sendai virus
• Mouse hepatits virus
• Pneumonia virus of mouse
• Minute virus
• Mouse parvovirus (MPV1-5)
• Theiler’s murine encephalomyelitis virus

Step 2 - Recovery

Assess the viability of the hybridoma cells in the cryovial you supply to us. If the culture viability is low, we attempt to recover viability cells and establish a healthy culture. If the culture viability is acceptable at thaw, recovery work is not required and we move directly to Clonality testing. Once a healthy culture is established, the clonality of the cell line is determined.

Step 3 - Clonality

The fraction of cells secreting monoclonal antibody (the clonality) in a healthy culture is determined. Monoclonal antibody yield is improved when the clonality of the cell line is high. Failing to determine the clonality of the cell line prior to production may lead to unexpectedly low yields of monoclonal antibody.

Step 4 - Subcloning

If the clonality of the culture is acceptable, the original culture is used for production work or cell banking work. If the clonality of the culture is unacceptable, SDIX subclones the original culture by selecting the best antibody-secreting clone. This subclone is used for production or cell banking.

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