Process Development
Top Productivity & Quality Modulation
Our team of upstream development experts specializes in thorough media and additive screening for optimal cell culture processes. We integrate extensive libraries and optimize screening processes through parameters.
- Molecule Information / Cell Bank Transfer
- Basal Media Screening in Shake Flask
- Feed Media Screening in Shake Flask
- Process Optimization in Ambr 15TM
- Process Verification Run in 2L STR
- Molecule Information / Cell Bank Transfer
- Basal Media Screening in Shake Flask
- Feed Media Screening in Shake Flask
- Process Optimization in Ambr 15TM
- Process Verification Run in 2L STR
Titer Enhancement Platforms
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S-Tensify™
S-Tensify™
- • An intensified cell culture platform that improves productivity by increasing the initial cell density (ICD) of a main culture through N-1 perfusion
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Quality Modulation Platforms
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S-Glyn™
S-Glyn™
- • A modular glycosylation platform to optimize glycosylation regarding ADCC and CDC functions through the Design-of-Experiment investigation
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Charge Variants Modulation
Charge Variants Modulation
- • A precise charge variant modulation platform achieved through a thorough screening process
- • Optimization of media, additives and process parameters (ICD, pH, shifted temperature, feeding rate)
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Refined Expertise and Streamlined Optimization
We utilize a robust downstream purification strategy and a diverse resin library to meet a wide range of purification needs,
ensuring flexibility with our efficient screening approach.
- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process Verification Run in AKTA
- Preparation for DSP Development
- Column Process Development
- Virus Inactivation Process Development
- Filter Process Development
- Process Verification Run in AKTA
Purity and Yield Improvement Through DoE
Our rigorous procedures have consistently resulted in maintaining or improving both yield and purity based on our project experiences.
BsAb (Project A)
- Purity (%)
- Feasibility result : 99.1%
- Development result : 99.0%
- Yield (%)
- Feasibility result : 22.0%
- Development result : 39.7%
Fc fusion (Project B)
- Purity (%)
- Feasibility result : 99.0%
- Development result : 99.4%
- Yield (%)
- Feasibility result : 68.7%
- Development result : 80.4%
mAb (Project C)
- Purity (%)
- Feasibility result : 91.5%
- Development result : 99.0%
- Yield (%)
- Feasibility result : 52.8%
- Development result : 67.4%
BsAb (Project A)
- Purity (%)
- Feasibility result : 99.1%
- Development result : 99.0%
- Yield (%)
- Feasibility result : 22.0%
- Development result : 39.7%
Fc fusion (Project B)
- Purity (%)
- Feasibility result : 99.0%
- Development result : 99.4%
- Yield (%)
- Feasibility result : 68.7%
- Development result : 80.4%
mAb (Project C)
- Purity (%)
- Feasibility result : 91.5%
- Development result : 99.0%
- Yield (%)
- Feasibility result : 52.8%
- Development result : 67.4%
Formulation and Drug Product Expertise
Drawing on their extensive experience, our team of experts in the DP/Formulation Development Group is dedicated to optimizing formulations to enhance product stability and efficacy.
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Surfactant
Screening -
pH/Buffer
Screening -
UF Feasibility
Study -
Excipient
Screening -
Determination of
Final Formulation
High Concentration Formulation Platform
Samsung Biologics' formulation platform maximizes drug delivery and stability through high concentration.
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High Concentration Formulation
High Concentration Formulation
- • Stable liquid formulation for 150 mg/mL SC injection
- • Achieved viscosity of less than 7 cP
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HMW species
- Standard formulation conditions
- Improved formulation conditions
Standard formulation conditions
- 0weeks 0.5% Area
- 2weeks 1.2% Area
- 4weeks 1.4% Area
- 6weeks 1.48% Area
- 8weeks 1.55% Area
Improved formulation conditions
- 0weeks 0.5% Area
- 2weeks 0.75% Area
- 4weeks 0.85% Area
- 6weeks 0.88% Area
- 8weeks 0.92% Area
HMW species
- Standard formulation conditions
- Improved formulation conditions
Standard formulation conditions
- 0weeks 0.5% Area
- 2weeks 1.2% Area
- 4weeks 1.4% Area
- 6weeks 1.48% Area
- 8weeks 1.55% Area
Improved formulation conditions
- 0weeks 0.5% Area
- 2weeks 0.75% Area
- 4weeks 0.85% Area
- 6weeks 0.88% Area
- 8weeks 0.92% Area
