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ProCLD Cell Line Development Services

Gene to Top 6 clones in 14 weeks

Gene to Top 1 clone in 18 weeks

Cell line development matters

Cell line development plays an essential role in drug development. It is the bridge connecting drug discovery and development, more over a good cell line development service can always save your valuable time and lower your final cost.

GenScript ProCLD cell line development services will provide you the cell lines with accelerated timeline, high quality delivery and extensive understanding of drug development to help you get your own success.

Fig. 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.

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

Fig. GenScript's cell line perform well from 2L to 200L scale.

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

  PreCLD ProCLD ProCLD Plus
Service details
  • Cell pool development & deveopability assessment
  • Cell line development
  • PCB & PCB stability
  • Cell line development
  • Feed & medium selection
  • Bioreactor performance evaluation
Application scenario
  • Generate materials for animal studies in the same host cell and vector system as CMC
  • Evaluate the developability of drug candidates
  • Preclinical CMC development
Titer for mAb Guaranteed>1 g/L Guaranteed >3g/L
Up to 8g/L
Guaranteed >4g/L
Up to 8g/L
Turnaround time 12 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
  • Cell pool development report
12
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



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