Overview
- Faster & Better
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As your most qualified world’s leading CDMO partner, Samsung Biologics delivers your success to IND & BLA Faster & Better with maximum flexibility.
We promise the Best.
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.
Why Samsung Biologics CDO?
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- Contract Development Timeline
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- From Gene to IND in 9 months (Cell Line Development → Process Development → cGMP Manufacturing → IND Filing)
- Accelerated Timelines (high productivity and stability)
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- Advanced Technology
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- Proprietary Cell Line, S-CHOice®
- Process Development Platform, S-Cellerate™
- Expertise in development of various molecules
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- Excellent Quality
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- mAb titer of 11.6g/L, Bispecific titer of 4+g/L
- Dedicated Project Management
- Regulatory Filing Support
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- Tailored Support
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- Flexible CDO Service scope
- Competitive & Variable Cost Structure
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- Seamless One-stop Service
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- Fully integrated development & manufacturing service
- Global #1 manufacturing capacity
