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Our All-In-One CDO Service Guide
- Q&A
- contract development service
Our All-in-One CDO Service Guide
Are you looking for a reliable partner who can help you develop your molecule to IND and beyond? Samsung Biologics offers tailored solutions to best guide your development journey. Learn more about our CDO services from these frequently asked questions.
Q1 Can you give a brief overview of your CDO portfolio?
- We have been developing various types of molecules, from mAbs to complex molecules.
- We've accumulated approvals from global regulatory agencies.
- Monoclonal antibody
- 60%
- Bispecific antibody
- 20%
- Fusion protein
- 14%
- Other
- 6%
A CDO projects by molecule types ("From 2018 to 2023)
- FDA(US)
- 60%
- MFDS(Korea)
- 31%
- Other(EU, Australia)
- 9%
A IND approval status ("As of Feb 2024)
Q2 What is Samsung Biologics' standard development timeline?
- 10 Months
- For mAbs, it's 10 months from cell line development to IND filing, and for complex molecules, it's 13 months.
- Cell Line Development 3 Month
- Process Development 3~7 Month
- Non-GMP DS/DP 6 ~ 8.5 Month
- Analytical Tech Transfer 7 ~ 9 Month
- CGMP DS 7.5 ~ 9 Month
- CGMP DP 9.5 ~ 10 Month
- Documentation for IND Filing 7 ~ 10 Month
Q3 Can you provide a developability assessment for my molecule?
DEVELOPICK™ is our rapid and agile assessment tool that scores drug candidates based on developability criteria to save you time and cost in the late discovery/early development stage. You can also secure quality material provision through our proprietary transient ex-pression platform S-CHOsient™.
1 Month
- Primary Structure Assessment
- Solubility
- Basic Characteristic Analysis
- Heat Stress Treatment
- Low & High pH Treatment
- Hydrophobic Interaction Analysis
- Data Reporting
Developability assessment process using DEVELOPICK™
Q4 What platforms do you offer throughout the project?
- DEVELOPICK™
- A developability assessment platform utilizing an in-house scoring system
- S-DUAL™
- An asymmetric BsAb platform allowing high yield & manufacturability with maximizing HC-LC pairing
- S-CHOsice
- High-performing CHO-K1-based cell line development platform
- S-CHOsient™
- A transient ex-pression platform using S-CHOice" with high-yield productivity and quality
- S-Glyn™
- A glycan profile modulation platform providing an in-depth investigation into the CQAs and cell culture conditions
Q5 What kind of flexibility do you offer?
- Simplified IND Package / accelerated timeline
- Comprehensive IND Package / Multifaceted Approach
- Enhanced CMC Package / Productivity Improvement
- Our Customized CMC Solutions are tailored to your specific development characteristics and stage.
-
Flexible service options for each development process:
- Cell line development: CHOZN® and S-CHOice®
- USP/DSP: Diverse media and resin options
- Analytics: Optimization of development process with additional analyses per client's request
Q6 Can you provide a seamless transition from clinical to commercialization?
- Total Capacity
- 784KL
- *Includes Plant 5, which will be operational in April 2025
- We offer a fully integrated CDMO service, supported by the world's largest biomanufacturing capacity at a single site
- Comprehensive in-house analytical capabilities
- Flexible batch sizes for your needs
- 1KL x 2 / Single-Use
- 1KL x 2 / Stainless Steel
- 5KL x 6
- 10KL x 6
- 15KL x 46
Q7 roadmap? zero net a have you Do
We are committed to achieving zero greenhouse gas emissions and 100% renewable energy across our sites and supply chains by 2050.
SiteBusiness (Scope 1&2) Emissions
- 2022
- Emissions : 100%
- 2030
- 32% reduction
- Emissions : 68%
- 62% reduction
- Emissions : 38%
- 100% reduction
- NET ZERO
- Emissions : 100%
Supply Chain (Scope 3) Emissions
- 2022
- Emissions : 94%
- 2030
- 36% reduction
- 73% reduction
- 100% reduction
- NET ZERO
Agile. Flexible. Focused on You
Want to learn more? Connect with our development experts today!
- Q&A
- contract development service
Our All-in-One CDO Service Guide
Are you looking for a reliable partner who can help you develop your molecule to IND and beyond? Samsung Biologics offers tailored solutions to best guide your development journey. Learn more about our CDO services from these frequently asked questions.
Q1 Can you give a brief overview of your CDO portfolio?
- We have been developing various types of molecules, from mAbs to complex molecules.
- We've accumulated approvals from global regulatory agencies.
- Monoclonal antibody
- 60%
- Bispecific antibody
- 20%
- Fusion protein
- 14%
- Other
- 6%
A CDO projects by molecule types ("From 2018 to 2023)
- FDA(US)
- 60%
- MFDS(Korea)
- 31%
- Other(EU, Australia)
- 9%
A IND approval status ("As of Feb 2024)
Q2 What is Samsung Biologics' standard development timeline?
- 10 Months
- For mAbs, it's 10 months from cell line development to IND filing, and for complex molecules, it's 13 months.
- Cell Line Development 3 Month
- Process Development 3~7 Month
- Non-GMP DS/DP 6 ~ 8.5 Month
- Analytical Tech Transfer 7 ~ 9 Month
- CGMP DS 7.5 ~ 9 Month
- CGMP DP 9.5 ~ 10 Month
- Documentation for IND Filing 7 ~ 10 Month
Q3 Can you provide a developability assessment for my molecule?
DEVELOPICK™ is our rapid and agile assessment tool that scores drug candidates based on developability criteria to save you time and cost in the late discovery/early development stage. You can also secure quality material provision through our proprietary transient ex-pression platform S-CHOsient™.
1 Month
- Primary Structure Assessment
- Solubility
- Basic Characteristic Analysis
- Heat Stress Treatment
- Low & High pH Treatment
- Hydrophobic Interaction Analysis
- Data Reporting
Developability assessment process using DEVELOPICK™
Q4 What platforms do you offer throughout the project?
- DEVELOPICK™
- A developability assessment platform utilizing an in-house scoring system
- S-DUAL™
- An asymmetric BsAb platform allowing high yield & manufacturability with maximizing HC-LC pairing
- S-CHOsice
- High-performing CHO-K1-based cell line development platform
- S-CHOsient™
- A transient ex-pression platform using S-CHOice" with high-yield productivity and quality
- S-Glyn™
- A glycan profile modulation platform providing an in-depth investigation into the CQAs and cell culture conditions
Q5 What kind of flexibility do you offer?
- Simplified IND Package / accelerated timeline
- Comprehensive IND Package / Multifaceted Approach
- Enhanced CMC Package / Productivity Improvement
- Our Customized CMC Solutions are tailored to your specific development characteristics and stage.
-
Flexible service options for each development process:
- Cell line development: CHOZN® and S-CHOice®
- USP/DSP: Diverse media and resin options
- Analytics: Optimization of development process with additional analyses per client's request
Q6 Can you provide a seamless transition from clinical to commercialization?
- Total Capacity
- 784KL
- *Includes Plant 5, which will be operational in April 2025
- We offer a fully integrated CDMO service, supported by the world's largest biomanufacturing capacity at a single site
- Comprehensive in-house analytical capabilities
- Flexible batch sizes for your needs
- 1KL x 2 / Single-Use
- 1KL x 2 / Stainless Steel
- 5KL x 6
- 10KL x 6
- 15KL x 46
Q7 roadmap? zero net a have you Do
We are committed to achieving zero greenhouse gas emissions and 100% renewable energy across our sites and supply chains by 2050.
SiteBusiness (Scope 1&2) Emissions
- 2022
- Emissions : 100%
- 2030
- 32% reduction
- Emissions : 68%
- 62% reduction
- Emissions : 38%
- 100% reduction
- NET ZERO
- Emissions : 100%
Supply Chain (Scope 3) Emissions
- 2022
- Emissions : 94%
- 2030
- 36% reduction
- 73% reduction
- 100% reduction
- NET ZERO
Agile. Flexible. Focused on You
Want to learn more? Connect with our development experts today!