01 Sino Biological

Company Overview

Track Record & Key Facts

Why Choose Sino Biological's CRO Services

Since 2007 Sino Biological Inc. has been offering high quality biological research reagents and comprehensive CRO services to accelerate life science research and biological product development worldwide.

• >400 scientists & engineers• >16,000 projects accomplished• >99% success rate • 12 days for protein production from DNA sequence in HEK293 cells• 99.9% monomer• 0.01 EU/mg endotoxin level• Serving top-10 global pharmaceutical/biotech companies

Over 10 years of experience with protein/antibody expression and

purification optimization

One-stopDNA seq. to protein/antibody

Flexible Production Scales Variable scales (20mL to 750L)

Fast Turnaround From gene sequence to purified protein within 4 weeks in HEK293 cells

Low-Risk Billed for milestones

High QualityProprietary technologyand optimized process

Core Technologies

Capacity• Large scale (>5,000 liters cell culture capacity per week)• High-throughput (>100 projects in parallel)• Over 40 stirred tank bioreactors for mammalian cell culture• High-throughput production at mg-scales for over 200 antibodies per week• High-throughput antibody purification and polishing at various scales (1 mg-100 mg)

ResearchReagent

CRO Service

Antibody Technologies

Cell Technologies

Gene Technologies

Virus Technologies

Five Expression Systems 1000+ Bio-activity Assays

Antibody Library Antibody Humanization

cDNA Library Expression-ready Vector

Experience of 5000+ Protein ProductionValidated Formulation Methods

Rabbit Monoclonal Antibody Single Cell PCR

Gene Knock-out qPCR

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Protein Technologies

Animal Cells Yeast CellsInsect Cells

T CellsStem Cells

Virus Vector Virus-like Particle

Pseudo VirusNeutralizing Antibody

03 Sino Biological

Recombinant Protein Production Service

HEK293Cell

CHOCell

5 Expression SystemsTransient/Stable expression

Yeast E. coli

Insect Cell

Technical Strength• Optimized expression vectors• High-density cell culture• Proprietary medium

• Experience of >7000 proteins• Protein refolding expertise• Expertise in drug R&D

Extensive Experience with Proteins that are:

• Secretory• Insoluble

• Intracellular• Enzymes

• Trans-Membrane • Heterogeneous polymers

Protein Expression Service Overview

Full Services From gene cloning/synthesis to purified proteins

General Expression Procedure

• Pilot phase

Small scale expression evaluation & optimization

• Production phase

Large scale protein production & purification

Purification With or without affinity purification tags (Fc, His, GST, FLAG, SUMO, Myc, HA)

Quality Specification

• Standard package

Typically >90% purity by SDS-PAGE

• Customized package

HPLC-SEC, endotoxin, activity, etc.

Deliverables• Purified proteins

• QC data

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Monoclonal Antibody Development Service

Mouse Monoclonal Antibody

Rabbit Monoclonal Antibody

Custom Monoclonal Antibody Development Process

>10,000 high quality monoclonal antibodies producedMultiple validation platforms: ELISA, IHC, IF, WB, FACS, IP, ICC and functional assays

Traditional Hybridoma Development

• Optimized electrofusion method• In vitro production and affinity purification• Hybridoma serum-free cell culture

• Phage display library construction• High-throughput antibody screening• High-throughput antibody production and

validation

Genetic Technology and Antibody Library

Mouse Mab/Rabbit Mab

Antigen • Peptide design, synthesis and conjugation

• cDNA cloning and recombinant protein production

Timeline 4-6 months

Deliverables

• Mouse Mab

1) Hybridoma cell lines

2) Purified mAb with COA

• Rabbit Mab

1) Antibody gene sequences and vectors containing H and L chains

2) Purified mAb with COA

Mouse Mab

Rabbit Mab

Immunization 8-10 weeks

Fusion &Screening2-3 weeks

Libraryconstruction

2-3 weeks

Subcloning2-3 weeks

Screening2-3 weeks

Expansion1 week

Vectorconstruction

1 week

Production & Validation2-3 weeks

Production & Validation3-4 weeks

05 Sino Biological

Production for various Antibody Molecules

Antibody Production

Quality Analysis and Validation

• Hybridoma serum-free cell culture & antibody purification• Recombinant production by transient transfection in HEK293 or CHO cells • Antibody expression with stable CHO cell lines

• IgG/IgA/IgM• Chimeric antibody• ScFv, Fab, Fab’ fragment• Bi-specific antibody• Mouse/rat/rabbit/rhesus/human

• UV, SDS-PAGE• HPLC-SEC, Reverse-phase HPLC• Endotoxin assay• Melting point, glycosylation analysis, LC-MS/MALDI-MS• Affinity assessment (Biacore/Octet)• ELISA, WB, IHC, FACS, IP, IF• Neutralization assay• CDC and ADCC assay

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Service List

Molecular Biology Services

Protein Production Services

Antibody Development

Analytical Services

Services for Pharmaceutical Drug Development

• Gene synthesis, gene cloning, vector construction, plasmid production• Real time PCR primer and probe design, qPCR / pRT-PCR analysis • CRISPR-Cas9 knockout cell line generation

• Mammalian expression: transient expression, stable CHO cell expression• Baculovirus insect cell expression• Yeast expression• E. Coli expression

• Rabbit polyclonal antibody development• Mouse monoclonal antibody development• Rabbit monoclonal antibody development• Hybridoma to recombinant antibody conversion• Large-scale antibody production and purification• Anti-idiotype antibody development

• Biochemical characterization• Biophysical characterization• Biological activity assays• Viral clearance validation

• Therapeutic antibody generation• Antibody humanization, antibody affinity maturation• Cell line engineering, cell banking• Process development, assay development, formulation development• GMP production