Agile. Flexible.
Focused on You.
With a focus on commercialization, our development experts
leverage their extensive experience to identify and manage
effective end-to-end processes, ensuring faster timelines
without compromising on quality.
Dedicated Development Services
Accelerate Your Development Journey
10 months from CLD to IND (Investigational New Drug Application)
Standard Timeline* (Months)
-
1
Cell Line Development -
2
Cell Line Development -
3
Process Development -
4
Process Development -
5
Process Development -
6
Process Development
Non-GMP DS/DP -
7
Non-GMP DS/DP
Analytical Tech Transfer
CGMP DS
Documentation for IND Filing -
8
Non-GMP DS/DP
Analytical Tech Transfer
CGMP DS
Documentation for IND Filing -
9
Documentation for IND Filing -
10
Documentation for IND Filing
CGMP DS Lot Release
CGMP DP Lot Release
Standard Timeline* (Months)
-
1
Cell Line Development -
2
Cell Line Development -
3
Process Development -
4
Process Development -
5
Process Development -
6
Process Development
Non-GMP DS/DP -
7
Non-GMP DS/DP
Analytical Tech Transfer
CGMP DS
Documentation for IND Filing -
8
Non-GMP DS/DP
Analytical Tech Transfer
CGMP DS
Documentation for IND Filing -
9
Documentation for IND Filing -
10
Documentation for IND Filing
CGMP DS Lot Release
CGMP DP Lot Release
Customized CMC Solutions
SelecTailor™
-
Learn more
SelecTailor™ Customized CMC Solutions
- Enhanced CMC Package
- Productivity Improvement
- Comprehensive IND Package
- Multifaceted Approach
- Simplified IND Package
- Accelerated Timeline
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. With our partnership, you will have access to in-depth knowledge and know-how for your molecule's unique characteristics.
Every biologics development journey is unique and complex. Therefore, flexible approaches are essential to paving the way into the clinic. Leveraging our diverse portfolio and proprietary platform processes, our team of experts will help you de-risk your journey while minimizing costs.
-
- Simplified IND
- Expedite timeline focused on IND Phase 1 by utilizing Samsung Biologics' platform
-
- Comprehensive IND
- Leverage wider scopes of study to mitigate the risk for development
-
- Enhanced CMC
- Replace cell line/process/formulation to improve key features