Process Development
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Faster Service and
Better Quality -
After completion of high-quality mammalian cell line development for a variety of antibodies and proteins, cell culture, purification, formulation and analytical development will take over simultaneously. Along with Samsung Biologics’ specialized cell line development know-how, our experts have extensive experience of molecule development including difficult-to-handle products and are capable of delivering robust, high-yield single cell clone to our clients.

- Upstream Process / 3.5 months
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- Molecule information / cell bank transfer
- Basal Media Screening in shake flask
- Feed Media Screening in shake flask
- Process Optimization in Ambr15™
- Process verification run in 2L STR
- Downstream Process / 4 months
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- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process verification run in AKTA
- Formulation / 2.5 months
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- Liquid Formulation
- Lyophilization Development
- Non-GMP Manual Filling
- Analytical Method / 4 months
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- Analytical Method Development
- Extended characterization & comparability studies
- Analytical Support
- Upstream Process 3.5 month image
-
- Molecule information / cell bank transfer
- Basal Media Screening in shake flask
- Feed Media Screening in shake flask
- Process Optimization in Ambr15™
- Process verification run in 2L STR
- Downstream Process 4 month image
-
- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process verification run in AKTA
- Formulation 2.5 month image
-
- Liquid Formulation
- Lyophilization Development
- Non-GMP Manual Filling
- Analytical Method 4 month image
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- Analytical Method Development
- Extended characterization & comparability studies
- Analytical Support