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Blockbusters (such as Humira, Enbrel and Herceptin) achieved huge success because of proven clinical efficacy, strong market demand, thourough IP protection and market penetration strategies. The strict R&D standards are the cornerstones of blockbuster.
In the past 10 years, GenScript has been sticking to the "blockbuster" standards to manage, research and deliver every therapeutic programs. GenScript delivers humanized, human and bispecific antibody leads with good biological efficacy, safety & manufacturability in 12-15 months, as your one-stop solution from Targets to Therapeutic Antibody Candidates.
| Target | Antigen
Prep |
|
| Binder | Antibody
Lead Generation |
|
| Functional Ab Lead | Antibody Lead
Characterization |
|
| Functional Optimized Lead with good manufacturability | Antibody Lead
Optimization |
|
| Optimized Lead with good biological efficacy, safety & manufacturability | In Vivo Efficacy, Exploratory PK & Toxicity Studies |
|
Acceleration Driver
Experience
- Murine Hybridoma Technology & Human Naïve Library Technology
- >400 therapeutic antibody discovery projects delivered
- Successful cases in IND
Expertise in Transmembrane Target
- Single transmembrane targets, such as immune checkpoints
- Multiple transmembrane targets, such as GPCR
Industrial Standards
- Delivered Functional Humanized/Human Antibody Lead with Good Developability
Power of Integration
- All-in-one supplier
- Save at least 5 months for antibody discovery program
Innovation Driver
- Innovative SMAB Bispecific Antibody
| Discovery Services | Testing Options | Deliverables | Timeline |
|---|---|---|---|
| M1: Antibody Lead Generation | Bioassays |
|
6-8 months |
|
Biochemical & Biophysical Assays
|
||
| M2: Antibody Lead Optimization | In Vivo Efficacy, Exploratory PK & Toxicity Studies |
|
6-7 months |
|
|
Lead Generation
- 12 antibody leads recognizing 2 distinct epitopes were obtained.
- 2 antibody leads with different epitopes were moved forward to lead optimization.
Lead Optimization
- 2 antibody leads were humanized and then tested by functional assay.
- Their developabilities were evaluated by both experimental & predicted approaches.
Antibody Humanization
| Ligand | Analyte | ka (1/Ms) | kd (1/s) | KD (M) | Rmax (RU) | Chi² (RU²) |
|---|---|---|---|---|---|---|
| Chimeric lgG | Antigen/His | 4.67E+05 | 1.00E-05 | 2.14E-11 | 38.3 | 3.40E-02 |
| Humanized Ab Lead | 7.05E±05 | 1.00E-05 | 1.42E-11 | 38.2 | 5.28E-02 |
Manufacturability Assessment
| Thermostability (Tm) | >60 °C (by DSC) |
|---|---|
| Extra Cys | No hotspot predicted, confirmed by Mass Spec |
| N-glycosylation | |
| Asn deamidation | |
| Asp isomerization | |
| Hydrolysis | |
| Oxidation | 2 hot spots predicted and confirmed by Mass Spec, Not impact binding by Biacore & on stability by SEC under forced oxidation |
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