End-to-End CDMO Development Services for Biologics
Agile. Flexible.
Focused on You.
With a focus on commercialization, our biologics CDMO experts
manage end-to-end development processes to reduce timelines
and maintain regulatory-grade quality.
Biologics CDMO Development Capabilities
Our integrated service offerings include: Late Discovery, Cell Line Development, Process Development, Analytical Development, and Non-GMP/CGMP Manufacturing - all to support faster IND filing.
Accelerated Biologics Development Timeline
9 months for mAb and less than 11 months for BsAb from gene to IND
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Months 1
VC*
-
Months 2
Cell Line Development
-
Months 3
Cell Line Development
Process development
-
Months 4
MCB Mfg.
Process Development
Non-GMP DS(tox.)
-
Months 5
Process Development
Non-GMP DS
Analytical method transfer
-
Months 6
Process Development
MCB Conditional Release
DP(Tox.)
Analytical method transfer
CGMP DS
-
Months 7
Analytical method transfer
CGMP DS
Regulatory Documentation
-
Months 8
CGMP DS Lot Release
CGMP DP
Regulatory Documentation
-
Months 9
Gene to IND filling 9months
CGMP DP lot Release
Regulatory Documentation
-
Months 1
VC*
-
Months 2
Cell Line Development
-
Months 3
Cell Line Development
Process development
-
Months 4
Cell Line Development
Process Development
-
Months 5
MCB Mfg.
Process Development
Non-GMP DS(tox.)
-
Months 6
Process Development
Non-GMP DS(tox.)
Analytical method co-qualification
-
Months 7
Process Development
MCB Conditional Release
DP(Tox.)
Analytical method co-qualification
-
Months 8
Analytical method co-qualification
CGMP DS
Regulatory Documentation
-
Months 9
Analytical method co-qualification
CGMP DS
Regulatory Documentation
-
Months 10
CGMP DS Lot Release
CGMP DP
Regulatory Documentation
-
Months 11
Gene to IND filling < 11months
CGMP DP Lot Release
*VC: Vector Construction
-
Months 1
VC*
-
Months 2
Cell Line Development
-
Months 3
Cell Line Development
Process development
-
Months 4
MCB Mfg.
Process Development
Non-GMP DS(tox.)
-
Months 5
Process Development
Non-GMP DS
Analytical method transfer
-
Months 6
Process Development
MCB Conditional Release
DP(Tox.)
Analytical method transfer
CGMP DS
-
Months 7
Analytical method transfer
CGMP DS
Regulatory Documentation
-
Months 8
CGMP DS Lot Release
CGMP DP
Regulatory Documentation
-
Months 9
Gene to IND filling 9months
CGMP DP lot Release
Regulatory Documentation
-
Months 1
VC*
-
Months 2
Cell Line Development
-
Months 3
Cell Line Development
Process development
-
Months 4
Cell Line Development
Process Development
-
Months 5
MCB Mfg.
Process Development
Non-GMP DS(tox.)
-
Months 6
Process Development
Non-GMP DS(tox.)
Analytical method co-qualification
-
Months 7
Process Development
MCB Conditional Release
DP(Tox.)
Analytical method co-qualification
-
Months 8
Analytical method co-qualification
CGMP DS
Regulatory Documentation
-
Months 9
Analytical method co-qualification
CGMP DS
Regulatory Documentation
-
Months 10
CGMP DS Lot Release
CGMP DP
Regulatory Documentation
-
Months 11
Gene to IND filling < 11months
CGMP DP Lot Release
*VC: Vector Construction
Customized CMC Development Solutions
SelecTailor™
delivers tailored CMC packages and IND support to accelerate early development.
SelecTailor™
SelecTailor™
Equipped with full suite of biopharma development and CMC services, Samsung Biologics provides tailored solutions aligned with your development strategy. Through SelecTailor™, you gain access to deep expertise in cell line development, analytical development, and process development - all designed to streamline your path from gene to IND.
Every biologics development journey is unique and complex. That's why flexibility is the key. Our team leverages proprietary platform processes and a diverse service portfolio to help you de-risk early-phase development while minimizing time and cost. Whether you need support with non-GMP / CGMP manufacturing, drug substance manufacturing, or quality assurance, we help efficiently move your molecule toward clinical success.
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Simplified IND
- Expedite timeline focused on IND Phase 1 by utilizing Samsung Biologics' platform
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Comprehensive IND
- Leverage wider scopes of study to mitigate the risk for development
-
Enhanced CMC
- Replace cell line/process/formulation to improve key features
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