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By Nov.2022

ProGram Stable Cell Pool and Material Generation Workflow

process

ProGram Package Highlights

生产服务亮点
High productivity stable pool (2-3g/L)
生产服务亮点
High batch to batch consistency
Product quality close to CMC sample
生产服务亮点
12 weeks from gene synthesis to purified material
生产服务亮点
Competitive package price
process
  • Upgrade the research pool to commercial pool with only 40% price higher in ProGram package
  • Save 2 months for future cell line development
  • 2x cell pool diversity, bigger chance to get higher titer pool
Service Service Content Deliverables Timeline ProGram Package Timeline
Research Cell Pool Development
(cell pool stored at GenScript or delivered)
Gene synthesis & plasmid preparation pUC57 plasmid
Top cell pools(3 vials/pool, 5.0*10^6 cells/ml, 1ml/vial);
ROA
10 week 12-13 week
Cell pool screening
Cell cryopreservation
Commercial Cell Pool Development
(cell pool stored at GenScript)
Gene synthesis & plasmid preparation ROA 10 week
Cell pool screening
Cell cryopreservation
Material Generation N liter cell culture & one-step purification Purified antibody 4-5 week

Product quality can be customized according to the request

Basic Product Quality (antibody)

Method Quality Standard
Concentration A280
Endotoxin level LAL/TAL Endotoxin Assay <10 EU/mg for all
<1EU/mg for most antibody
Purity SEC-HPLC
SDS-PAGE
>95%
Buffer PBS

GenScript also provides Developability Assessment service to identify the potential developability risk and help to select the CMC candidates.

Service Service Content Deliverables Timeline
Basic Developability Assessment
(optional)
40℃ Report: Tagg, concentration, purity 6-8 week
Low pH 3.5
Premium Developability Assessment
(optional)
40℃ Report: Tagg, Tm, concentration, purity, charge variant profiles 6-8 week
Low pH 3.5
Freeze & Thaw