Understanding Disease Mechanism: Antibody therapeutics are used to combat different diseases such as cancers, autoimmune disease, infectious disease and more. Many technologies are available to identify a target and are often used in combination, these include but are not limited to: biochemical methods, genetic interactions, and computational inference.
Target Gene Validation: To validate targets, scientists use techniques such as cell-based models, phenotypic models, IHC, FACS, WB, for target engagement to demonstrate that the target is involved in the progression of a given disease.
Lead Identification & Optimization
Lead identification is the process of generating antibody candidates using the validated target. Animals are immunized in order to generate hybridomas that produce target specific monoclonal antibodies. Antibody candidates are screened for functionality and further optimized for affinity and stability. The antibody leads are prepared and carried through to begin the next stage of the drug development process.
Once a lead is confirmed, the pre-clinical phase of drug development begins with in vivo research on non-human subjects for efficacy, toxicity, and pharmacokinetic (PK) data collection. After completion, scientists review and determine whether the drug can be moved to clinical trials in people.
The IND application identifies the intended use of the treatment for a condition and will outline manufacturing information and clinical protocols. The data collected during the pre-clinical stage will support movement to clinical trials by demonstrating preliminary safety and efficacy.
The clinical trial assesses drug safety and efficacy in healthy volunteers and patients. The data collected will help establish pharmacokinetics, absorption, metabolism, and elimination within the body, as well as any side effects for safe dosage ranges. The clinical trial design is complex and its high cost and implementation issues can affect each stage carried out through its duration.
Analytical Products and Services
Learn more about our technologies to support antibody drug discovery. Find the information you need in our educational materials database.
Head of Antibody Department, GenScript
Sr. Field Application Scientist
Dr. Edward Wong
Field Application Scientist, GenScript
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