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Basedon "integratedR&Dplatformforinnovativeantibodydrugs" and "super-trillioninnovativeantibodydiscoveryplatform". Sanyou Bio can customize the screening strategies for the best antibody candidates suitable for gene therapy. SanyouBio also providesall-in-one R&D servicesfromtargettogenetherapeuticantibody.

Service Overview Basedon"integratedR&Dplatformforinnovativeantibodydrugs"and"super-trillioninnovativeantibodydiscoveryplatform". SanyouBio can customize the screening strategies for the best antibody candidates suitable for gene therapy SanyouBio also providesall-in-one R&D servicesfromtargettogenetherapeuticantibody. Service Contents Service Service Contents Provided by Clients Deliverables (and standards) Delivery Cycle (month) Antibody services 1. Material preparation 2. Antibody production 3. Antibody engineering 4. Nucleotide conjugation 5. In vivo/in vitro drug efficacy screening 1.Target ID 2. Project objectives 3. Nucleic acid targets and linkers 1. Data report: stage reports and project data package 2. In vivo and in vitro drug efficacy 3. Pharmacokinetics 9–13 (fully validated candidates) Segments of gene therapeutic drug R&D stages Material preparation 1. Human/monkey antigen and receptor 2. Antibody control (benchmark) 3. Human and monkey cell lines Target ID 1. SDS-PAGE > 85% 2. ELISA activity identification: consistent with the literature 3. FACS activity identification: the expression of target antigen is 10 times higher than background 1 Antibody production 1. Humanized antibody library, mouse/alpaca immune library 2. Affinity maturation (if required) 3. Antibody humanization (if required) Raw materials 1. Deliver ≥ 20 sequence-specific leads with human-monkey cross-activity 2. Improved affinity up to 5~20 times after engineering with humanization > 90% 3. Humanized antibody function is similar to or better than that of the parental antibody 1. 1–2 2. 1 3. 2 Nucleotide conjugation 1. Antibody conjugation 2. Post-conjugation molecule quality assessment Purified qualified antibody 1. Qualified AOC 2. Data report 1 In vitro model screening 1. Internalization 2. Target antigen knockdown (qPCR) 3. ADCC, CDC Purified qualified antibody 1. Functional screening: deliver ≥ 3 equivalent or better candidates 2. Data report: data report on functional screening 1–2 In vivo model screening 1. Two animal models for validation 2. PK 3. Tissue-specific target knockdown Selected AOC 1. Functional screening: deliver ≥ 3 equivalent or better candidates 2. Data report: the screening of efficacy in animals 2–4 Service Highlights 1. Integrated platform for innovative antibody drug discovery 10 functional modules and 25+ sub-platforms covering the whole procedure of drug discovery Project with comprehensive arrangement; PCC can be completed in 12 months 2. Distinctive capability for multi-route antibody discovery Trillion-capacity antibody library; thousands of leads can be obtained for common targets Diversified antibody sources: human recombinant library, semi-synthetic trillion-capacity VHH library, mouse immune library, alpaca immune VHH library, polypeptide library, and common light chain library Full coverage of antibody types: full human antibody, single domain antibody, common light chain bispecific antibody, mouse monoclonal antibody, and rat monoclonal antibody Antibody types: IgG, Fab, VHH 3. Extensive project experience 20+ scientists expertized in various fields with the capability of systematic review of specific project 100+ projects experience and high success rate 4. Customized service Combination of innovative target / linker / intracellular nucleic acid Integrated service platform in the antibody development Case Presentations 1. In Vitro Efficacy Evaluation based on MOA of Gene Therapeutic Antibody 1.1. Cellular binding and epitope analysis Cellular binding methods: Utilization of flow cytometry to detect the binding of different candidate to over-expressed cell lines. Cellular binding results: The candidates exhibit a superior or similar binding activity to the benchmark. Fig. 1A Cellular binding activity assay Epitope analysis methods: Competition method with biotinylated of benchmark to group epitopes. Epitope analysis results: All candidates can competitively inhibit the binding of Target Ab to the antigen, which indicated that the candidates recognize the same epitope. Fig. 1B Cell competitive binding assay 1.2. Endocytosis Efficacy assay Test method Instruments Suitability Principle Fab-Zap method Microplate reader primary screening secondary antibody conjugated with saporin enters the cells through internalization and subsequently induces proliferation blockage Double fluorescence membrane-breaking method Flow cytometer Secondary screening The antibody triggers the internalization process at 37 °C, and the amount of endocytosed antibody can be detected by double fluorescence and membrane- breaking staining pH Rodo method Microplate reader primary screening Antibodies labeled with pH-sensitive dyes are engulfed by target cells and acidified in the endosome to release fluorescent signals Confocal microscopy Confocal microscope Secondary screening Real time detection of drug transport and endocytosis by laser scanning confocal microscope Fluorescence quenching method Flow cytometry primary screening The antibody triggers the internalization process at 37 °C, and the amount of endocytosed antibody can be detected by quenching extracellular fluorescence and membrane-breaking staining Fig. 1C Fab-Zap endocytic activity assay 2. In Vivo Efficacy Evaluation based on MOA of Gene Therapeutic Antibody 2.1. In vivo imaging system SanyouBio has been equipped with the IVIS Lumina III Imaging System to observe the progress of tumor growth and metastasis, and to analyze the tissue distribution of drugs. Fig. 2A In vivo imaging by IVIS Lumina III Imaging System 2.2. Pharmacokinetics Provide one-stop services for the high-quality preparation of antigen/antibody and the development and verification of antibody PK in multi-species (rat, mouse, rabbit, dog, and minipig). Service Animal type Monoclonal antibodies Rats, mice, rabbits, dogs, and minipigs Multi-specific antibodies Rats, mice, rabbits, dogs, and minipigs Recombinant proteins Rats, mice, rabbits, dogs, and minipigs ADC molecules Rats, mice, rabbits, dogs, and minipigs Anti-drug antibody detection Rats, mice, rabbits, dogs, and minipigs Fig. 2B Sanyou Bio animal PK services and PK data display 2.3. Animal efficacy assessment A mature prefabricated Cell Line Derived (CDX) Tumor Model for assessment of gene therapeutic antibodies in vivo. Figure 2C. A431 (head and neck cancer cell line, EGFRhigh) CDX Tumor Model and its efficacy assessment in vivo. Fig. 2C Head and neck cancer A431 tumor model and efficacy assessment Core Services Provide comprehensive solutions to satisfy unmet medical needs based on the specificity and internalization property of antibodies that bind to the intracellular target siRNA / ASO / tRNA / Crispr.

Service Contents

Service

Service Details

Client Provides

Deliverables and Standards

Time

Antibody Services

1. Material preparation

2. Antibody production

3. Antibody engineering

4. Nucleotide conjugation

5. In vivo and In vitro drug efficacy screening

1.Target ID

2. Project objectives

3. Nucleic acid targets and linkers

1. Data report: stage reports and project data package

2. In vivo and In vitro drug efficacy

3. Pharmacokinetics

9–13 months

Segments of gene therapeutic drug R&D stages


Material preparation

1. Human/monkey antigen and receptor

2. Antibody control (benchmark)

3. Human and monkey cell lines

Target ID

1. SDS-PAGE > 85%

2. ELISA activity identification: consistent with the literature

3. FACS activity identification: the expression of target antigen is 10 times higher than background

1 months

Antibody production

1. Humanized antibody library, mouse/alpaca immune library

2. Affinity maturation (if required)

3. Antibody humanization (if required)

Raw materials

1. Deliver ≥ 20 sequence-specific leads with human-monkey cross-activity

2. Improved affinity up to 5~20 times after engineering with humanization > 90%

3. Humanized antibody function is similar to or better than that of the parental antibody

1. 1–2 months

2. 1 months

3. 2 months

Nucleotide conjugation

1. Antibody conjugation

2. Post-conjugation molecule quality assessment

Purified qualified antibody

1. Qualified AOC

2. Data report

1 months

In vitro model screening

1. Internalization

2. Target antigen knockdown (qPCR)

3. ADCC, CDC

Purified qualified antibody

1. Functional screening: deliver ≥ 3 equivalent or better candidates

2. Data report: data report on functional screening

1–2 months

In vivo model screening

1. Two animal models for validation

2. PK

3. Tissue-specific target knockdown

Selected AOC

1. Functional screening: deliver ≥ 3 equivalent or better candidates

2. Data report: the screening of efficacy in animals

2–4 months


Service Highlights
  • 1. Integrated platform for innovative antibody drug discovery
    1. 10 functional modules and 25+ sub-platforms covering the whole procedure of drug discovery
    2. Project with comprehensive arrangement; PCC can be completed in 12 months
  • 2. Distinctive capability for multi-route antibody discovery
    1. Trillion-capacity antibody library; thousands of leads can be obtained for common targets
    2. Diversified antibody sources: human recombinant library, semi-synthetic trillion-capacity VHH library, mouse immune library, alpaca immune VHH library, polypeptide library, and common light chain library
    3. Full coverage of antibody types: full human antibody, single domain antibody, common light chain bispecific antibody, mouse monoclonal antibody, and rat monoclonal antibody
    4. Antibody types: IgG, Fab, VHH
  • 3. Extensive project experience
    1. 20+ scientists expertized in various fields with the capability of systematic review of specific project
    2. 100+ projects experience and high success rate
  • 4. Customized service
    1. Combination of innovative target / linker / intracellular nucleic acid
    2. Integrated service platform in the antibody development

Case Studies
1. In Vitro Efficacy Evaluation based on MOA of Gene Therapeutic Antibody

1.1. Cellular binding and epitope analysis

Cellular binding methods: Utilization of flow cytometry to detect the binding of different candidate to over-expressed cell lines.

Cellular binding results: The candidates exhibit a superior or similar binding activity to the benchmark.


Fig. 1A Cellular binding activity assay


Epitope analysis methods: Competition method with biotinylated of benchmark to group epitopes.

Epitope analysis results: All candidates can competitively inhibit the binding of Target Ab to the antigen, which indicated that the candidates recognize the same epitope.


Fig. 1B Cell competitive binding assay


1.2. Endocytosis Efficacy assay


Test method

Instruments

Suitability

Principle

Fab-zap method

Microplate reader

primary screening

secondary antibody conjugated with saporin enters the cells through internalization and subsequently induces proliferation blockage

Double fluorescence membrane-breaking method


Flow cytometer


Secondary screening

The antibody triggers the internalization process at 37 °C, and the amount of endocytosed antibody can be detected by double fluorescence and membrane-breaking staining

pH rodo method

Microplate reader

primary screening

Antibodies labeled with pH-sensitive dyes are engulfed by target cells and acidified in the endosome to release fluorescent signals

Confocal microscopy

Confocal microscope

Secondary screening

Real time detection of drug transport and endocytosis by laser scanning confocal microscope

Fluorescence quenching method


Flow cytometry

primary screening

The antibody triggers the internalization process at 37 °C, and the amount of endocytosed antibody can be detected by quenching extracellular fluorescence and membrane-breaking staining


Fig. 1C Fab-Zap endocytic activity assay

2. In Vivo Efficacy Evaluation based on MOA of Gene Therapeutic Antibody

2.1. In vivo imaging system

Sanyou Bio has been equipped with the IVIS Lumina III Imaging System to observe the progress of tumor growth and metastasis, and to analyze the tissue distribution of drugs.


Fig. 2A In vivo imaging by IVIS Lumina III Imaging System


2.2. Pharmacokinetics

Provide one-stop services for the high-quality preparation of antigen/antibody and the development and verification of antibody PK in multi-species (rat, mouse, rabbit, dog, and minipig).


Service

Animal Type

Monoclonal antibodies

Rats, mice, rabbits, dogs, and minipigs

Multi-specific antibodies

Rats, mice, rabbits, dogs, and minipigs


Recombinant proteins

Rats, mice, rabbits, dogs, and minipigs


ADC molecules

Rats, mice, rabbits, dogs, and minipigs

Anti-drug antibody detection

Rats, mice, rabbits, dogs, and minipigs



Fig. 2B Sanyou Bio animal PK services and PK data display


2.3. Animal efficacy assessment

A mature prefabricated Cell Line Derived (CDX) Tumor Model for assessment of gene therapeutic antibodies in vivo.

Figure 2C. A431 (head and neck cancer cell line, EGFRhigh) CDX Tumor Model and its efficacy assessment in vivo.


Fig. 2C Head and neck cancer A431 tumor model and efficacy assessment


Core Services

Provide comprehensive solutions to satisfy unmet medical needs based on the specificity and internalization property of antibodies that bind to the intracellular target siRNA / ASO / tRNA / Crispr.