GenWay Biotech, Inc'

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GenWay Biotech, Inc.
Antigen and Antibody Solutions for Diagnostics
Meeting the Needs of Target Validation, Assay
Development, and Diagnostic Kit
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Corporate Highlights

• Founded in 1998
• Antigen production
• World leader in chicken antibody (pAb/mAb)
• Immunoassays and ELISA kits
• Shark antibody platform
• Proteomic RD and biomarker validation
• cGMP manufacturing
• Extensive client and leads network
• Successes in BD and corporate partnership

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GenWay Technical Capability

• Core Competencies
• Bioinformatics and knowledge database
• Recombinant protein production
• Antibody production/applications
• Monoclonal IgY, shark NAR, and IgG
• Immunoassays ELISAs, rapid tests, etc.
• Products Successfully Tested
• Applicable to most common immunoassays
• More than 2,000 clients/researchers have used
  products
• Diagnostics products successfully developed and
  marketed
• Production Capacity 60 proteins/30
  antibodies/month
• 60 recombinant protein/month, scalable to
  200/month
• 30 antibodies/month, scalable to gram quantities
• Catalog Products
• More than 25,000 products online

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Advanced Antibody platforms

• Avian IgY antibodies
• Recombinant scFv antibodies
• Shark NAR antibodies

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Why Chickens IgYs?
Hen
Rabbit
Distance to Human
-205 Myr
72 Myr
Affinity Maturation
Gene Conversion
Somatic Mutation
Avidity
High
Good
Production
Accumulative
Invasive
Monthly
20 Eggs
50 ml Blood
Ab Quantity
100 mg/egg
10 mg/ml
Maintenance
Low
High
Unit Cost
Low
High
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IgY Less Non-Specific Binding
No Binding to Fc Region
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Polyclonal Antibody Production
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Comparison of IgY and IgG
A
B
C
Immuno- precipitation
Immuno-staining
Western Blot
IgY
IgG
IgY
IgG
Anti-Calnuc IgY (Golgi-Specific)
Calnuc
35S Labeling
ECL Detection
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Monoclonal Antibody Productionrecombinant scFv
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Shark Antibodies

• Small size (12 kD)
• Rapidly clearance
• penetration capacity
• Highly soluble
• Dont have hydrophobic interface
• Dont need a linker (scFv)
• Highly stable
• 4M Urea and
• boling at 100 C
• Sharks can be immunized with lethal mammalians
  proteins

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Shark Antibodies
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Protein Expression Contract Services

• Bioinformatics Analysis

• Vector Design and Construction

• System Selection and Adaptation

• Protein Expression and Optimization

• Refolding and Solubilization

• Scale-Up Production

• GLP/cGMP Compliance

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Three-Tiered Multi-Level System
Vector Construction, Codon Engineering, Domain
Selection and Protein Fusion
Expressed Proteins Deposit and Collection
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Protein Expression in E. coli Protein
Refolding-Function
TGFß2
Cell Inhibition Assay ED50 35 pg/ml
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Protein ExpressionYeast and Mammalian
Yeast
Mammalian
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Immunoassay development

• ELISA assays
• Sandwich
• Direct
• Competitive
• Rapid tests

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HIV Diagnostic Kit