Based
on ”Super-trillion
Innovative Antibody Discovery Platform”
and
“Integrated
Innovative Antibody Drug
Preclinical R&D
Platforms”. Sanyou
Bio provides integrated pre-clinical
candidate (PCC) drug R&D services.
The
solutions include drug-target validation, material preparation, antibody generation, in vitro efficacy
evaluation, antibody engineering, in vivo efficacy
assessment and other on-demand studies to ensure the delivery of PCC antibody drugs with promising developability potential.
Service Overview
Based on ”Super-trillion Innovative Antibody Discovery Platform” and “Integrated Innovative Antibody Drug Preclinical R&D Platforms”.Sanyou Bio provides integrated pre-clinical candidate (PCC) drug R&D services.
The solutions include drug-target validation, material preparation, antibody generation, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies to ensure the delivery of PCC antibody drugs with promising developability potential.
Service Contents
Service Type
Service Contents
Provided by Clients
Deliverables and Standards
Timeline (month)
PCC Projects
1. material preparation
2. antibody discovery
3. antibody humanization
4. antibody affinity maturation
5. in vitro efficacy screening
6. in vivo efficacy screening
1. Target Information
2. R&D requirements
1.Data reports: stage reports and project data reports 2.Deliverables: 2-3 candidate antibodies with activities comparable or superior to control antibodies
8-12
Drug PCC Development Stages Breakdown
Material Preparation
1. human/monkey/mouse antigens, receptor/ligand and family proteins
2. control antibodies
3. human/monkey/mouse antigen expressing cell lines
Target Information
1. SDS-PAGE>85%
2. ELISA:activity is consistent as in the literature
3. FACS:expression level 10 times higher than the background
1
Antibody Discovery
1. mouse immune library
2. alpaca immune library
3. fully human library
Materials
1. Delivery of lead antibodies: delivery of ≥20 monoclonal lead antibodies with human-monkey cross-reactivity
1-2
In Vitro Efficacy Screening
1. method development of the required assays
2. in vitro screening of the candidate antibodies
Purified and Qualified Antibodies
1. Functional screening: delivery of ≥3 antibody molecules with activities comparable or superior to control antibodies
2. Data report: in vitro functional screening data reports
1-2
Antibody Humanization
1. humanization design
2. plasmid construction, expression and purification
3. antibody function validation and drug developability assessment
Candidate Antibody Sequences
1. Humanness rate: degree of humanization>90%
2. Antibody characterization: activities of the humanized antibody is similar to or superior to that of the parental antibody
3. Data report: humanization data reports
1
Affinity Maturation
1. library construction strategy development
2. library construction and screening
3. antibody function validation and drug developability assessment
Candidate Antibody Sequences
1. Affinity: the affinity of the engineered antibody is 5-20 times better than that of the parental
2. In vitro efficacy: the in vitro efficacy of the candidate antibody is significantly better than that of the parent
3. Data report: antibody affinity maturation reports
2
In Vivo Efficacy Screening
1. method development of the required models
2. in vivo screening of the candidate antibodies
3. pharmacokinetic analysis
Candidate Antibodies
1. In vivo screening: delivery of ≥2 antibody candidates with in vivo activities comparable or superior to the control antibodies
2. Data report: in vivo drug efficacy screening data reports
2-4
Service Highlights
1. Integrated Solutions
All-in-one solutions include target validation, material preparation, antibody discovery, in vitro efficacy evaluation, antibody engineering, in vivo efficacy assessment and other on-demand studies.
2. Super-trillion Antibody Libraries
with the support of large-capacity antibody libraries (7×1012),thusands of lead molecules can be obtained for conventional drug targets, and potential lead molecules can be derived from multiple layers of screening.
3. Experienced in R&D
Our team has more than 100 successful PCC development experience with various disease targets, which guarantees the success of project development.
4. Comprehensive Validations
The candidate molecules are fully verified by affinity, specificity, drug efficacy in vivo and in vitro, and exploitability to ensure the quality.
5. Solid Scientific Foundation
Supported by more than 50 scientists,we provide value-added services for the project by completing target research and project recommendation.
6. Industry-leading Expert Team
Well-established and reliable services provided by nearly 300 experienced scientists in the R&D team.
7. Extensive Successful Cases
Successfully project deliveries to more than 300 global pharmaceutical companies with 80% repeated orders.
8. Client-oriented Business Model
Diverse and flexible business models are generated following client-oriented and result-oriented principles.
Case Presentations
As of February 2022, Sanyou has experiences of nearly 100 drug PCC development covering various antibody formats and indications.
The above chart shows the number of PCC projects completed annually by Sanyou in the recent years, where 68 PCC projects are expected to be completed in 2022.
The above chart shows the formats of the PCC antibodies that Sanyou has completed, including monoclonal antibodies, bi-specific antibodies, tri-specific antibodies and ADC.
The above chart shows a variety of indications of targets that are under development by Sanyou, which focus on oncology and autoimmunity, meanwhile cover infection, ophthalmology and metabolism.
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