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CDO Services
개요
Clinical Phase
Discovery &
PreclinicalPhase I
Phase II
Phase III
BLA/NDA
Process Development Stages
Process Development
for FIH1)Process Development
for CommercialProcess Characterization & PPQ2) support
CPV3) & Commercial Improvements
Cell line
development
3~5 RCB
development
3~5 RCB
Long-
term
stability
term
stability
MCB/WCB mfg. &
characterization
characterization
Upstream process development
Downstream process development
Analytics method development
Tech. Transfer
to CMO site
to CMO site
Scale-up &
Tox. material production
Tox. material production
Eng. run & GMP manufacturing (Drug substance -> Drug product)
Ready to submit FDA/EMA
Excipient screening
Service area of Protium Science
1) first in human2) process performance qualification3) commercial process validation
서비스 범위
Area 1: QBD-Based Development
- Cell line development
- Transient production
- RCB 선정 (3~5개 clone)
> Monoclonality 확보 (image) - Long-term stability (~35 passages)
* RCB: research cell bank
- USP and DSP
- Media (USP) & resin (DSP) screening
- Small scale Process development & lock
- Scale-up study
- Tox. material production
- Analytics method
- Method development for release test
- Method qualification for release test
- Characterization Study for DS/DP & Tox material
- Formulation/DP mfg. study
- 제형 개발 및 최적화(고형 또는 액상제형)
- 고형 제형 생산을 위한 생산 cycle 최적화
- DS (원료)/DP (완제) stability study
Area 2: Consulting
- Development strategy
- Cell banking: MCB and WCB
- Tech. Transfer to CMO Mfg. 관련 study
- Manufacturing managing
- Briefing Document /
IMPD for IND submission
Area 3: Process Characterization
- Risk assessment
- Classification of parameters
- Scale-down modeling
- Control strategy
- Experiments based on DoE and RSM
- Report
Area 4: Training
- Operation
- Tools for development