Upstream Process Development
Top Productivity & Quality Modulation
Our upstream process development team specializes in advanced media and additive screening to drive optimal cell culture performance. We leverage extensive libraries and fine-tune parameters to enhance productivity and stability, ensuring scalable and efficient biologics process development. This upstream expertise supports robust transitions into downstream process development and aligns with overall biopharma manufacturing goals.
- 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(Antibody Dependent Cellular Cytotoxicity) and CDC(Complement-Dependent Cytotoxicity) functions through the Design-of-Experiment investigation
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S-OptiChargeTM
S-OptiChargeTM
- • 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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Downstream Process Development
Refined Expertise and Streamlined Optimization
We apply a robust downstream process development strategy using an extensive resin library to address a wide spectrum of purification needs. Our streamlined and efficient screening approach enhances flexibility and consistency across diverse molecule types. These capabilities support high-yield recovery and critical quality attributes, complementing our broader drug substance manufacturing workflows.
- 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/DP Development
Formulation and Drug Product Expertise
With deep expertise in formulation development and drug product development, our DP/Formulation Development Group focuses on optimizing formulations to enhance both product stability and therapeutic efficacy. These capabilities are integrated across programs to ensure consistency from early-stage development through drug product manufacturing.
High Concentration Formulation Platform
Samsung Biologics' high concentration formulation platform is engineered to maximize drug delivery efficiency and ensure product stability, supporting complex modalities and delivery routes.
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S-HiCon TM
S-HiCon TM
- • Stable liquid formulation for 150 mg/mL SC injection
- • Achieved viscosity of less than 7 cP
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HMW (High Molecular Weight) 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 (High Molecular Weight) 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
Phase-appropriate Process
Development with QbD
Our process development services employ a phase-appropriate development approach grounded in Quality by Design. We apply structured biologics process development methodologies to support early and late-stage programs, utilizing design-of-experiment techniques in JMP software and our robust, in-house analytical development capabilities. This ensures precise control and scalability throughout upstream and downstream process development.