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Significance of Cell Line Development in Drug Development

ProCLD cell line development service has shown great performance both in stability and productivity , see below figures for more information.

ProCLD shows up to 8.7g/L prior to cell culture

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Fig. Titer at day 13 in Fed-batch culture using platform feeding strategy, without optimization

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Fig. GenScript ProBio's cell line shows excellent scale-up stability from 3L to 200L

Cell pool and developability assessment help to identify the potential developability risk and help to select the CMC candidates.

Cell pool evaluation

Candidates Cell pool Titer /mg/L
A Middle
B Middle 
C High

Developability: Candidate C was chosen and finally succeed in CMC.

Stability  Analytical methods Changes from Tday0 and Tend
Candidate A Candidate B Candidate C
Free-thawn Appereance Remain the same Remain the same Remain the same
Stressful (40℃ & 2 weeks) Appereance Remain the same Remain the same Remain the same
CE-SDS-NR Decrease ca.10% Remain the same Remain the same
SEC-HPLC Remain the same Remain the same Remain the same
PTM by MS ~ 10% deamidation (not CDR) ~ 10% deamidation (not CDR) ~ 5% Oxidation (not CDR)
cIEF Acidic and basic increased Main peak changed Acidic and basic increased
Bioactivity Remain the same Remain the same Remain the same
 Acidic condtion (pH3.5 & 25°C  & 4h)  Appereance Remain the same slight suspension slight suspension
SEC-HPLC Decreased ca. 70% Decrease ca.40% Decrease ca.5%
PTM by MS ~ 10% deamidation (not CDR) ~ 20% Oxidation (CDR) Remain the same
cIEF Remain the same Main peak changed Remain the same
Bioactivity Remain the same Decreased Remain the same
  PreCLD ProCLD ProCLD Plus
Service details
  • Cell pool development
  • deveopability assessment(optional)
  • Cell line development
  • Top 6 clones
  • PCB & PCB stability
  • Cell line development
  • Feed & medium selection
  • Ambr 15 bioreactor performance evaluation
  • Top 1 clone
Application scenario
  • Generate materials for animal studies in the same host cell and vector system as CMC
  • High batch to batch consistency compared to transient expression
  • Evaluate the developability of drug candidates
  • Preclinical CMC development
Titer for mAb Guaranteed>1 g/L Guaranteed >3g/L
Up to 8.7g/L
Guaranteed >4g/L
Up to 8.7g/L
Turnaround time 10 weeks 14 weeks 18 weeks

PreCLD Cell Pool Package


Service Service Content  Deliverables Timeline (week)
PreCLD Cell Pool Development Gene synthesis & plasmid preparation
  • pUC57 plasmidCryopreserved
  • cells (3 cell pools) Delivery to client or stored in GenScript ProBio
  • Cell pool development report
10
Cell pool screening
Cell cryopreservation
Basic Developability Assessment 40℃ Report: Tagg/onset, concentration, purity profiles 6-8
Low pH 3.5
Premium Developability Assessment 40℃ Report: Tagg/onset, concentration, purity profiles, charge variant profiles 6-8
Low pH 3.5
freeze-thaw

ProCLD Cell Line Development Package


  Service Content  Deliverables Timeline (week)
ProCLD Cell Line Development Gene synthesis & plasmid preparation
  • Plasmid construct map;
  • Stable cell line development final report;
  • 6 PCB
14 
Cell pool screening
Cell clone screening
Fed-batch evaluation
PCB generation
PCB 60 generation stability study
  • Report of stability study
14-15
ProCLD  plus Cell Line Development Media & Feed screening & ambr 15 mini bioreactor clone evaluation
  • Top 1 clone and a back-up clone
  • Report
4