Overview

Antibody drugs, also known as therapeutic antibodies, have gained significant success and momentum in the field of drug discovery and development. These drugs are designed to target specific molecules in the body, such as proteins or cells, and have been increasingly utilized for the treatment of various diseases, including cancer, autoimmune disorders, and infectious diseases.

The success of antibody drugs can be attributed to their high specificity and affinity for their targets, as well as their ability to modulate the immune system and exert therapeutic effects. They have shown remarkable efficacy in treating a wide range of conditions, often with fewer side effects compared to traditional small molecule drugs.

The growing use of antibody drugs is evident in the increasing number of approved therapeutic antibodies across different disease areas. Their success has spurred the exploration of new and evolving formats, such as bispecific antibodies, antibody-drug conjugates, and engineered antibodies, which offer enhanced targeting capabilities and novel mechanisms of action.

To address the rise of antibody drugs, there has been a parallel expansion of technologies and platforms to support their discovery and development. These include advanced screening and selection methods, novel protein engineering tools, and innovative manufacturing processes aimed at improving the potency, safety, and manufacturability of antibody drugs.

GenScript's comprehensive solutions play a crucial role in supporting antibody drug discovery and development by providing a range of tools and services that cover the entire drug development process. From target identification to lead generation and optimization, as well as preclinical and clinical stages, GenScript aims to streamline and simplify the workflow for scientists and researchers.

Antibody Drug Discovery

Antibody Drug Discovery Workflow

Target
Identification
1
Lead Generation & Optimization 2
Preclinical
Studies
3
Clinical
Development
4

Target Identification

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

Innovative techniques, such as phage display, advanced hybridoma technology, and single-cell sequencing, are utilized to generate diverse libraries of antibodies, allowing the identification of highly specific and potent leads. These methodologies enable rapid screening and selection of antibody candidates based on their functionality, affinity, and stability, thereby streamlining the lead identification process.

Following the identification and optimization of antibody leads, advanced technologies like antibody sequencing and humanization, ensure that the selected candidates are thoroughly characterized and prepared for the subsequent stages of the drug development process, setting the stage for the successful translation of research into potential therapeutic interventions.

Preclinical Studies

Once a lead is confirmed, the preclinical 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 preclinical stage will support movement to clinical trials by demonstrating preliminary safety and efficacy.

Clinical Studies

The clinical trial assesses drug safety and efficacy in healthy volunteers and patients. The data collected will help establish pharmacokinetics (ADME: absorption, distribution, 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.

Industry Insights

Resources

Learn more about our technologies to support antibody drug discovery. Find the information you need in our educational materials database.

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