Poster
ProGram Fast
ProGram Fast - Gram Level Fast Sample Preparation
1 Gram mAb Delivered in 5 weeks
Abstract
Therapeutic biological products, such as antibodies and recombinant proteins, have emerged
as Aa mbasjotrrcalacsts of drugs offering new clinical applications. Due to advantages in terms of fast
speed and high yield, mammalian transient expression systems have gained popularity for
effectively producing proteins of pharmaceutical interest. In GenScript ProBio, we have
established a CHO-K1 fast sample production platform that provides “ProGram Fast” service for
the rapid and flexible production of antibodies and proteins.
“ProGram Fast” service can deliver 1 gram monoclonal antibodies with high purity in as fast as
5 weeks starting from DNA sequence. With the same host cells CHO-K1 and similar expression
vector pGenHT1.0-sUP utilized for IND-enabling CMC development, our “ProGram Fast” is
highly suitable for rapidly producing proteins for preclinical studies and selecting drug
candidates at an early stage.
ProGram Fast - Gram Level Fast Sample Preparation Service
Advantages of “ProGram Fast”
• Fast Delivery
ProGram Fast is applicable for a wide
range of molecules, including
monoclonal antibodies, bispecific
antibodies, multispecific antibodies,
recombinant proteins, and fusion
proteins.
√ 1 gram mAb delivered in 5 weeks
ProGram
• High Titer
Fast
√ mAb average titer 1.5 g/L, up to 3.4 g/L
√ bsAb average titer 0.8 g/L, up to 1.5 g/L
• CHO-K1 Cell
√ the same host cell used in CMC development
Service Package
Yield
Deliverables
Timeline
Application
QC
1 g to 75 g
Purified proteins, ROA
5 to 8 weeks (from gene synthesis)
Determine CMC candidate, Developability assessment
UV280, SDS-PAGE, SEC-HPLC
SEC-HPLC: ≥95% for antibody, ≥90% for recombinant protein;
Endotoxin≤1EU/mg
Delivery Standard
It will take one extra week for delivery of antibodies without Fc region and untagged recombinant proteins with the same delivery standard.
Case Study
Asymmetric bispecific antibody
mAb IgG1
Titer performance
Purity performance
SDS-PAGE
Titer performance
Purity performance
SDS-PAGE
Conclusion
ProBio now provides the “ProGram Fast” service for the rapid and flexible production of antibodies and proteins. Starting with the DNA sequence, the
“ProGram Fast” generates 1 to 75 grams of high purity antibody and protein products in 5 to 8 weeks. The average titer of monoclonal antibody is 1.5
g/L, with a maximum of 3.4 g/L. “ProGram Fast” utilizes the same host cells CHO-K1 and a similar expression vector simplified from pGenHT1.0-UP as
CMC development to quickly produce different molecules. The samples produced are ideal for assessing developability and identifying the lead drug
candidate at an early stage.