Rapid analysis of the efficacy of ready-made medicines
Constream Biotech has extensive experience in assessing the druggability of various new molecules such as monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs), protein engineering, candidate molecule construction and expression, and in vitro efficacy evaluation. This allows for effective bridging between new drug R&D and CMC pharmaceutical development, facilitating the advancement of superior molecules to the next stage of development.
Constream Biotech has extensive experience in the druggability assessment, protein engineering modification, candidate molecule construction and expression, and in vitro efficacy evaluation of various new molecules such as monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs). This allows for effective bridging of new drug development and CMC pharmaceutical development, facilitating the advancement of superior molecules to the next stage of development.
Core Technological Advantages
Comprehensive Assessment System
Physicochemical Property Analysis: Assessment of antibody aggregation tendency, charge heterogeneity, and thermal stability (Tm value > 70℃ preferred) using techniques such as SEC-HPLC, CE-SDS, and DLS.
Immunogenicity Prediction: Prediction and elimination of ADA (anti-drug antibody) risk in humanized antibodies by combining AI algorithms and in vitro T cell activation experiments.
Functional Activity Verification: Multi-dimensional efficacy verification through SPR/BLI affinity determination (KD at pM level), cell killing/blocking experiments, and in vivo efficacy models (PDX, humanized mice).
Developability Assessment: Optimization of expression vectors and host cells (CHO/HEK293) to achieve high-titer (>5g/L) and stable large-scale production.
Rational Design Optimization
Enhanced Stability: Improving antibody resistance to proteolysis and serum half-life through site-directed mutagenesis or glycosylation modification.
Reduced Aggregation Risk: Replacing hydrophobic residues and optimizing the charge distribution in the CDR region to ensure that the monomer content in the formulation is >95%.
Humanization Refinement: Employing a CDR grafting + framework region optimization strategy to retain activity while reducing the incidence of HAMA (human anti-mouse antibody) reactions to <5%.
Service Content
Serial Number | Molecular Characteristics | Assessment Methods |
1 | Sequence and Structural Assessment | In Silico Method |
2 | Molecular Size and Purity | SEC-HPLC Method |
3 | Molecular Size and Purity | Reducing CE-SDS Method |
4 | Molecular Size and Purity | Non-reducing CE-SDS Method |
5 | Isoelectric Point | iCIEF Method |
6 | Charge Purity | iCIEF Method |
7 | Charge Purity | CEX-HPLC Method |
8 | Mass Spectrometry Molecular Weight | RP-MS Method |
9 | Post-translational Modification | RP-MS/MS Method |
10 | Solubility | PEG Method |
11 | Thermal Stability (Tm/Tagg) | UNCle Method |
12 | Colloidal Stability (kD) | UNCle Method |
13 | Particle Size | UNCle Method |
14 | Self-Interaction | AC-SINS Method |
15 | Non-specific Binding | BVP Method |
16 | Non-specific Binding | Non-target Cell Method |
17 | Binding to Proteins in the Same Family | BLI Method/ELISA Method |
18 | Binding to Proteins from Different Species | BLI Method/ELISA Method |
19 | PK-related Characteristics | Heparin Column Method |
20 | Antigen Affinity | BLI Method |
21 | Biological Activity | Cell Method |
22 | Fc Function Assessment | BLI Method (Different Receptors Optional) |
23 | ADCC/CDC/ADCP | Cell Method |
24 | Plasma/Serum Stability | Cell Method |
25 | Endocytosis | Cell Method |
26 | Bystander Killing Effect | Cell Method |
27 | Cell Cycle Arrest | FACS Method |
28 | Forced Degradation Stability | High temperature, light, strong oxidants, high pH, low pH, freeze-thaw, shaking, as needed. |
Serial Number | Quality Research | Analytical Methods | |
1 | Denaturing Mass Spectrometry Molecular Weight Analysis | RP-MS Method | |
2 | Non-denaturing Mass Spectrometry Molecular Weight Analysis | SEC-MS Method | |
3 | Amino Acid Full Sequence Analysis | RP-MS/MS Method | |
4 | Post-translational Modification Analysis | RP-MS/MS Method | |
5 | Extinction Coefficient Analysis | RP-HPLC-FLD Method | |
6 | N-glycosylation Site Identification | RP-MS/MS Method | |
7 | N-glycosylation Composition Analysis | HILIC-FLD Method | |
8 | Sialic Acid Content Analysis | RP-HPLC-FLD Method | |
9 | Free Thiol Analysis | Ellman Assay Method | |
10 | Disulfide Bond Analysis | RP-MS/MS Method | |
11 | Secondary/Tertiary Structure Analysis | Circular Dichroism Method | |
12 | Tertiary Structure | Protein Intrinsic Fluorescence Scanning Method | |
13 | Bispecific Antibody Mismatch Analysis | (iCIEF or HIC) /CE, etc. | |
14 | Sequence Variant Analysis | RP-MS/MS Method | |
15 | Acid-base Peak Collection and Identification | CEX-HPLC/RP-MS, etc. | |
16 | Aggregate fragment collection and identification | SEC-HPLC/RP-MS, etc. | |
17 | DAR heterogeneity collection and identification | HIC-HPLC, RP-MS, etc. | |
18 | Qualitative analysis of high-risk HCPs | RP-MS/MS Method | |
19 | Quantitative analysis of high-risk HCPs | RP-MS/MS Method | |
20 | HCP coverage analysis | 2D-WB method | |
21 | HCP coverage analysis | RP-MS/MS Method | |
22 | Analysis of Tween degradation products | RP-HPLC-CAD method | |
23 | Average DAR value analysis | HIC or RP method | |
24 | DAR value distribution analysis | HIC or RP method | |
25 | Coupling site analysis | RP-MS/MS Method | |
26 | Aggregate form identification | SEC-MALS method | |
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Shanghai Constream biotechnology Co., Ltd.
Tel: 021-59255902
Address: 3rd Floor, Building 28, No. 10688, Beiqing Highway, Qingpu District, Shanghai
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