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CDO Services
개요
Clinical Phase

  • Discovery &
    Preclinical

  • Phase I

  • Phase II

  • Phase III

  • BLA/NDA

Process Development Stages

  • Process Development
    for FIH1)

  • Process Development
    for Commercial

  • Process Characterization & PPQ2) support

  • CPV3) & Commercial Improvements

Cell line
development
3~5 RCB
Long-
term
stability
MCB/WCB mfg. &
characterization
Upstream process development
Downstream process development
Analytics method development
Tech. Transfer
to CMO site
Scale-up &
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