Overview
- Faster & Better
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삼성바이오로직스는 세계 최고 수준의 CDMO 파트너로서, 고객의 성공적인 IND(Investigational New Drug)와 BLA(Biologics License Application)를 위해 고객의 요구에 맞추어 빠르고 더 나은 서비스를 제공합니다.
언제나 최고를 약속드립니다.
Your molecule’s journey with Samsung Biologics’ Faster & Better CDO service.
Cell line development begins by the insertion of your gene of interest into an expression vector. The transfected cell expresses your target antibodies and the antibodies are secreted from the cells.
A large number of cell pools are then screened and single cell clones are isolated based on high titre and product quality. At the end of this process, the top 5 research cell banks are ranked and one is moved into process development.
During upstream process development, basal and feed media are optimised to ensure cell stability In bioreactors, pH, dissolved oxygen, temperature and other parameters are continuously optimised for the cell’s growth and viability to maximise production of your target protein.
Your target protein can be isolated through chromatography steps such as affinity and ion-exchange resin in downstream process. Impurities and viruses can be removed through chromatography and filter steps
In parallel with process development, optimal analytical conditions are set for your protein through size-exclusion chromatography, ELISA and more. A full spectrum of methods will be developed to evaluate purity, impurities, content and identification.
Buffers, surfactants and excipients are screened and combined to generate a stable liquid or lyophilized formulation for your target protein.
With the completion of the development process, your molecule moves into clinical production. Finally, the molecule is filled into vials ready for clinical trial.
As your most qualified world’s leading CDO, CMO, CRO partner, Samsung Biologics delivers your success to IND & BLA Faster & Better with maximum flexibility. We promise the Best.
왜 삼성바이오로직스 CDO인가?
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- 빠른 서비스
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- 세포주 개발 부터 DP생산까지 7개월 소요 (세포주 개발⟶ DS, DP 생산 ⟶ 임상 허가 신청)
- 신속하고 고객 맞춤형의 타임라인 제공가능
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- 뛰어난 개발 능력
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- 자체 세포주, S-CHOice™ 와 삼성 자체 공정 개발 플랫폼 보유
- 다양한 물질 개발 경험 및 전문가 보유
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- 우수한 품질
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- 항체 11.6g/L, 이중항체 4g/L 이상의 titer로 생산 경험 보유
- 프로젝트별 전담 인력 배치를 통한 밀착 관리
- 69건 이상의 글로벌 규제기관 승인 (IND & BLA)
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- 맞춤 서비스
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- 고객 니즈에 맞춘 유연한 CDO 서비스 제공
- 경쟁력 있는 맞춤형 가격 정책
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- 원스탑 서비스 제공
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- 위탁개발 부터 위탁 생산까지 통합된 CDMO 서비스 제공
- 세계 최대 규모, 최고 수준의 생산 시설 보유
