Accelerate your development journey - 11 months from CLD to IND filing
Non-GMP DS/
DP Production
cGMP DS/
DP Production
IND Filing
Support
Clinical
With commercialization in mind, our development experts with extensive experience identify and manage effective end-to-end process, achieving faster timelines while ensuring quality.
Standard Timeline*(Months) *mAb
- 1~2
- Cell Line Development
- 1~5
- Process Development
- 5~7
- Non-GMP DS/DP
- 7~8
- Analytical Tech Transfer
- 9
- cGMP DS lot Release
- 7~8
- cGMP DS
- 9
- cGMP DP
- 11
- cGMP DP Lot Release
- 6~11
- Documentation for IND filing
Customized CMC Solutions
From Gene to IND - Claim your bespoke package
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Integrated CMC Service | Benefits
Samsung Biologics offers customized solutions to optimize your development journey. With our partnership, you will have access to in-depth knowledge and know-how for your molecule’s unique characteristics.
Customized Package Options
- Simplified IND package
- Accelerated Timeline
- Comprehensive IND package
- Multifaceted Approach
- Enhanced CMC package
- Productivity Improvement
Identification, recommendation, and delivery of fully a optimized service package tailored to your specific characteristics and development stage
- Seamless Service From Gene to IND
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- ▪ End-to-end service from development to clinical/commercial
- ▪ Proven expertise and track records, ensuring dedicated know-how
- Time and Cost Optimization
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- ▪ Accelerated timelines by leveraging utilization of proprietary platforms
- ▪ Cost minimization through one-stop process
Integrated CMC Service | Customized Solutions
Modular program to best fit your strategy
- Accelerated Timeline - Simplified IND Package
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Expedite timeline focused on IND Phase 1 by utilizing in-house platform
- Compact service focused on reducing timeline
- Efficient journey to IND
- Utilization of Samsung Biologics’ platform
- Multifaceted Approach - Comprehensive IND Package
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Provide widen scopes of study to mitigate the risk for development
- Detailed assessment service for risk minimization
- Thorough journey to IND/BLA
- Preliminary study of quality attributes for late phase and BLA
- Productivity Improvement - Enhanced CMC Package
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Replace cell line/process/formulation to improve key features
- CMC replacement service to meet the clients’ need for improvement
- Seamless journey to commercial
- Leverage know-how based on proven track records
Each development journey is unique yet complex, and therefore flexible approaches are essential for paving the right way to the clinic. Equipped with a range of comprehensive service options that align with your specific development strategies, Samsung Biologics offers tailored solutions to best guide your development journey.
Leveraging our diverse portfolio and proprietary platform processes, our team of experts will help you de-risk your journey while minimizing cost.
Connect with our development experts
