공정 개발
Top Productivity & Quality Modulation
최적의 세포 배양 공정 개발을 위해 배지 및 첨가물 스크리닝을 수행하며, 광범위한 라이브러리를 활용해 스크리닝 공정을 최적화합니다.
- 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™
- • N-1 단계의 접종세포농도를 높여 최종세포배양단계(N)에 접종 시 생산성을 향상시키는 세포 배양 플랫폼
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Quality Modulation Platforms
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S-Glyn™
S-Glyn™
- • 항체의 ADCC* 및 CDC** 기능 강화를 위한 실험계획법(Design of Experiment) 기반 글리코실화 최적화 플랫폼
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*ADCC: Antibody-dependent cell-mediated cytotoxicity (항체의존성 세포매개 세포독성)
**CDC: Complement dependent cytotoxicity (보체 의존적 세포독성)
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Charge Variants Modulation
Charge Variants Modulation
- • 전반적인 배지 및 첨가물 스크리닝을 통한 단백질 전하변이 조절 플랫폼
- • 미디어, 첨가제 및 공정 기준 최적화 (ICD*, pH, shifted temperature, feeding rate)
- * ICD: Initial Cell Density
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Refined Expertise and Streamlined Optimization
체계적인 전략과 레진 라이브러리를 활용해 다양한 정제 조건에 유연하게 대응합니다.
- 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
삼성바이오로직스의 정제 공정 개발 프로젝트 결과를 확인해보세요.
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
의약품의 안정성과 유효성을 높일 수 있도록 최적화된 제형을 개발합니다.
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Surfactant
Screening -
pH/Buffer
Screening -
UF Feasibility
Study -
Excipient
Screening -
Determination of
Final Formulation
High Concentration Formulation Platform
고농도 제형 플랫폼은 체내 약물 전달과 안정성을 극대화해 피하주사(SC*)나 유리체 내 주사에서 발견되는 약물 전달 문제를 해결합니다. *SC: Subcutaneous Injection
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High Concentration Formulation
High Concentration Formulation
- • 150 mg/mL 피하주사(SC)를 위한 안정적인 액체 제형
- • 7 cP 미만의 점도
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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
