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Service Overviews

Humanized antibodies and fully human antibodies could possibly induce anti-drug antibody (ADA) response as the exogenous antibodies may still possess immunogenicity. Therefore, it is critical to include the ADA test and screening of the clinical candidates, analysis of the in vivo ADA intensity and ADA neutralization effect (immunogenicity analysis), and detection of the plasma concentration (pharmacokinetic analysis) during the drug developability assessment of the antibody drugs.


Based on the technology of mouse immunization and phage display antibody library, Sanyou provides polyclonal and monoclonal ADA customization services. By applying antibody discovery and production methods that combine mouse immunization, arrayed phage antibody library construction and magnetic beads based high-throughput screening technology, polyclonal and monoclonal ADA can be rapidly and effectively prepared and purified with a yield that is ten thousand times higher than the hybridoma preparation. Antibody libraries with the capacity of 108 guarantee high diversity. Polyclonal and monoclonal ADAs for different targets can be delivered with assured quality and quantity.

Service Overviews Humanized antibodies and fully human antibodies could possibly induce anti-drug antibody (ADA) response as the exogenous antibodies may still possess immunogenicity. Therefore, it is critical to include the ADA test and screening of the clinical candidates, analysis of the in vivo ADA intensity and ADA neutralization effect (immunogenicity analysis), and detection of the plasma concentration (pharmacokinetic analysis) during the drug developability assessment of the antibody drugs. Based on the technology of mouse immunization and phage display antibody library, Sanyou provides polyclonal and monoclonal ADA customization services. By applying antibody discovery and production methods that combine mouse immunization, arrayed phage antibody library construction and magnetic beads based high-throughput screening technology, polyclonal and monoclonal ADA can be rapidly and effectively prepared and purified with a yield that is ten thousand times higher than the hybridoma preparation. Antibody libraries with the capacity of 108 guarantee high diversity. Polyclonal and monoclonal ADAs for different targets can be delivered with assured quality and quantity. Service Contents Service Service Contents Deliverables and Standards Time "Two in one" polyclonal and monoclonal ADA customization Deliverable 1: Polyclonal antibodies Polyclonal antibody serum (2 rabbits: 40–80 mL of serum; 3 mice: 1.5 mL of serum) 59 days Deliverable 2: Monoclonal antibodies 1. 3–10 antibodies, 200 μg each 2. Antibody detection sensitivity reaches 0.1–10 ng 30 days Deliverable 3: mg-level Antibody samples 1. Purified antibodies 2. Quality control reports 14 days Service Highlights 1. 108 antibody libraries with great diversity and a yield ten thousand times higher than hybridoma preparation Phage display library technology is applied to build large libraries with great diversity. Clear antibody sequence facilitates the further construction of various genetically engineered antibodies. 2. 3 rounds of panning, 4 rounds of ELISA screening, sequencingof 100 clones, and antibodies with superior affinity guaranteed Recombination of antibody heavy chain and light chain genes is equivalent to an in vitro affinity maturation of the antibodies. 3–10 antibodies with superior affinity and high specificity are screened from tens of millions antibodies with high efficiency and effectiveness. 3. Antibodies with clear sequences can be delivered in 90 days It takes only 90 days to deliver monoclonal anti-drug antibodies by applying molecular biology technologies, which is nearly half of the time comparing to the hybridoma technology. Through primer sequencing, antibody sequences can be delivered for subsequent antibody engineering and mass production of antibodies. Case Stastics 1. Higher Antibody Affinity The affinity of antibodies obtained from screening service of the phage display antibody library can usually reach pM level. As shown in Fig. 1, nine high-affinity candidate antibodies were obtained through phage display antibody library screening. Their affinity reached pM level, which is higher than that of the control antibody. Fig. 1 Affinity ranking 2. Cell Based Blocking Activity Analysis Sanyou prepares monoclonal antibodies using phage display antibody library technology and delivers antibodies with good in vitro activity. Fig. 2 shows the blocking activity of the antibodies to receptor ligand binding tested by FACS. As shown in the figure, the lead antibody exhibited binding and blocking activities superior to the control antibody. Fig. 2 Blocking activity determination by FACS

Service Contents

Service

Service Details

Deliverables and Standards

Time

"Two in one" polyclonal and monoclonal ADA customization

Deliverable 1: Polyclonal antibodies

Polyclonal antibody serum (2 rabbits: 40–80 mL of serum; 3 mice: 1.5 mL of serum)

59 days

Deliverable 2: Monoclonal antibodies

1. 3–10 antibodies, 200 μg each

2. Antibody detection sensitivity reaches 0.1–10 ng

30 days

Deliverable 3: mg-level Antibody samples

1. Purified antibodies

2. Quality control reports

14 days



Service Highlights
  • 1. 108 antibody libraries with great diversity and a yield ten thousand times higher than hybridoma preparation
    1. Phage display library technology is applied to build large libraries with great diversity.
    2. Clear antibody sequence facilitates the further construction of various genetically engineered antibodies.
  • 2. 3 rounds of panning, 4 rounds of ELISA screening, sequencingof 100 clones, and antibodies with superior affinity guaranteed
    1. Recombination of antibody heavy chain and light chain genes is equivalent to an in vitro affinity maturation of the antibodies.
    2. 3–10 antibodies with superior affinity and high specificity are screened from tens of millions antibodies with high efficiency and effectiveness.
  • 3. Antibodies with clear sequences can be delivered in 90 days
    1. It takes only 90 days to deliver monoclonal anti-drug antibodies by applying molecular biology technologies, which is nearly half of the time comparing to the hybridoma technology.
    2. Through primer sequencing, antibody sequences can be delivered for subsequent antibody engineering and mass production of antibodies.

Case Studies
1. Higher antibody affinity

The affinity of antibodies obtained from screening service of the phage display antibody library can usually reach pM level. As shown in Fig. 1, nine high-affinity candidate antibodies were obtained through phage display antibody library screening. Their affinity reached pM level, which is higher than that of the control antibody.


Fig. 1 Affinity ranking

2. Cell based blocking activity analysis

Sanyou prepares monoclonal antibodies using phage display antibody library technology and delivers antibodies with good in vitro activity. Fig. 2 shows the blocking activity of the antibodies to receptor ligand binding tested by FACS. As shown in the figure, the lead antibody exhibited binding and blocking activities superior to the control antibody.



Fig. 2 Blocking activity determination by FACS