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Solutions for Therapeutic Antibody Development
Therapeutic antibodies have revolutionized the field of targeted therapy by specifically recognizing and binding to tumor biomarkers, thereby enabling precise treatment strateiges. Therapeutic antibody development involves target identification, antibody generation, screening & selection, preclinical studies, clinical trials, regulatory approval, and finally, commercial production. The innovation and significant of therapeutic antibody development lie in the precise targeting, improved efficacy, and expanded therapeutic options for patients. To support the entire journey of therapeutic antibody development, from discovery to market, we provide solutions throughout the entire development workflow. Spanning from discovery and development to clinical applications, we are dedicated to delivering solutions designed to help you drive innovation and push the boundaries of what therapeutic antibodies can be.
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Discovery & DevelopmentTarget selection is a first step in therapeutic antibody discovery.
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CMC - ManufacturingManufacturing therapeutic antibodies is a complex and intricate process.
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CMC - Quality ControlStrict quality control and adherence to regulations are essential to ensure quality.
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Preclinical StudiesIn vivo and in vitro models assist in evaluating toxicity, mechanism of action and safety.
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Clinical Studies The final hurdle uses human subjects to gather critical data for regulatory approval.
Discovery & Development
- Discovery & Development
- Immunization
- Antibody Screening
- Cross-Species Validation
- Function Verification
- Structural Analysis
- Antibody Modification
- Antibody Evaluation
Discovery & Development
The discovery and development of antibody drugs are crucial for biopharmaceuticals. They offer targeted treatments by recognizing and binding to specific targets, such as pathogens or cancer cells. Antibody drugs have the potential to revolutionize healthcare by providing precise and effective therapies for various diseases, improving patient outcomes.
Immunization
Immunization is to use target antigens to select appropriate animals (such as mouse, llama, rabbit) for immunization, to prepare specific antibodies with strong specificity, high affinity, and high titer. The selection of an appropriate immunological regimen is critical to the success of cell fusion hybridization and thus the production of high-quality antibodies.
- FLAG Transmembrane Proteins
- Immune Checkpoint Proteins
- Cytokine Target Proteins
- CD3 Proteins
- TME Pathway Target Proteins
- Neuroscience Proteins
- Overexpression Cell Lines
Antibody Screening
In the early drug development process, antibody screening and optimization is an important step. At present, the conventional technologies widely used include hybridoma technology, antibody library screening technology, B cell cloning technology and other screening technologies. Common methods include ELISA and FACS cell level binding and blocking, SPR/BLI affinity detection, etc.
- Target Proteins
- Biotinylated Target Proteins
- Overexpression Cell Lines
- Inhibitor Screening Kits
- Biotinylated Protein-coupled Magnetic Beads
- ComboX: Streptavidin Series Products
- ComboX: Universal Antibodies
- ComboX: Isotype Controls
- Antibody Screening Service-ELISA Platform
- SPR/BLI Affinity Sorting and Epitope Analysis Services
- Recombinant Antibody Expression Service
Cross-species Validation
Only antibodies that can cause species cross-reaction can be used in preclinical animal experiments to verify and evaluate the efficacy of antibodies. Therefore, species cross validation is an important step in the process of antibody drug development. Common species cross-validation methods include ELISA, SPR, BLI, and flow cytometry.
- Multiple Species Target Proteins
- Multiple Species Fc Receptor Proteins
- Biotinylated Target Proteins
- SPR/BLI Analysis Services
Function Verification
Only antibodies that can cause species cross-reaction can be used in preclinical animal experiments to verify and evaluate the efficacy of antibodies. Therefore, species cross validation is an important step in the process of antibody drug development. Common species cross-validation methods include ELISA, SPR, BLI, and flow cytometry.
- Target Proteins
- Biotinylated Target Proteins
- Inhibitor Screening Kits
- Overexpression Cell Lines
- Reporter Cell lines
- Cell Line Customize Service
- Cytokines for Cell Culture
- Mogengel Matrix Basement Membrane Extracts
- T cell Activation/Expansion Reagents
- Cytokine Detection ELISA Kits
- SPR/BLI Analysis Services
Structural Analysis
The function of an antibody depends on the epitopes it binds to the antigen. Depending on the epitopes, antibodies perform specific functions, such as activating or inhibiting activity. A good antibody candidate requires high specificity and appropriate affinity for functional epitopes. Therefore, the structural analysis of antibody drugs at this stage is mainly site analysis, and commonly used methods include SPR, BLI and ELISA.
- Target Proteins
- SPR/BLI Analysis Services
Antibody Modification
Antibody modification includes humanization, Fc affinity modification and druggability modification. It focuses on the optimization of immunogenicity, affinity maturation and other issues, aims to find a balance between effectiveness and safety. ELISA, SPR/BLI and other methods were commonly used to verify the affinity changes, cell function changes and ADCC/ADCP/CDC cell function verification before and after the modification.
- Target Proteins
- Fc Receptor Proteins
- SPR/BLI Analysis Services
Antibody Evaluation
Properties of therapeutic antibody include physical, chemical, and biochemical characteristics, determined by the protein's sequence and structure, which can vary with specific targets. Drugability is the inherent property of the molecule, primarily established during early sequence modifications, but influenced by subsequent manufacturing processes (e.g., aggregation, degradation) and clinical trials (metabolism, pharmacology, immunogenicity). Therefore, evaluating the drugability of antibody drugs is crucial.
- Target Proteins
- Biotinylated Target Proteins
- Inhibitor Screening Kits
- Overexpression Cell Lines
- Cytokines for Cell Culture (Premium Grade)
- T cell Activation/Expansion Reagents
- Cytokine Detection ELISA Kits
- Enzymes for Antibody Characterization
- Anti-idiotype Antibodies
- Quality Characterization Analytical Service
- ELISA Service
- SPR/BLI Analysis Services
- Anti-idiotype Antibody Development Services, Immunogenic Reagents, and Kit Development Services
CMC-Manufacturing
- CMC-Manufacturing
- Scale-up Production
- Purification Process Development
- Formulation Process Development
CMC-Manufacturing
In the phase of antibody drug production, the modified antibody gene is introduced into an appropriate expression system (e.g., bacteria, yeast, mammalian cells, etc.) to enable the expression and production of large quantities of antibody protein. This usually involves steps such as construction of appropriate expression vectors, cell culture and fermentation, and protein purification. At the same time, in order to ensure the success of drug development and shorten the development cycle. The production process must focus on the analysis of the quality characterisation of the antibody drug and the accurate detection of nuclease residues.
Scale-up Production
Large-scale production of therapeutic antibodies in the CMC process involves cell culture, purification, formulation to ensure safe and effective therapies in sufficient quantities. In the production of the drug substance, cell culture techniques are typically employed for large-scale production of the target antibody using expression systems.
- Recombinant Antibody Services
Purification Process Development
In antibody drug production, nucleases are used to remove residual nucleic acids for optimal results and enhanced product safety. However, trace residues of nucleases can impact product application and may cause toxicity or immune reactions. Accurate detection of nuclease residues is crucial for ensuring product quality and safety.
- GENIUSTM Nuclease
- Nuclease Residue Detection Kit
Formulation Process Development
Due to the significantly larger molecular weight of antibody drugs compared to small molecule drugs and the potential for modification changes or particle aggregation during the manufacturing process, it is essential to perform quality characterization analysis at different stages of their lifecycle and production. This ensures successful drug development and shortens the development timeline.
- UNcle Quality Characterization Analytical Service
CMC- Quality Control
- CMC- Quality Control
- Bioactivity Evaluation: In Vitro Functional Assay
- Bioactivity Evaluation: In Vitro Functional Assay - Mechanism of Action
- Immunological Activity Evaluation: In Vitro Functional Assay- Affinity
- Antibody Immunological Activity Detection: In Vitro Functional Assay - Cell Lines
- Structural and Thermal Stability Analysis
- Safety Evaluation: Residue Detection
CMC- Quality Control
Quality control plays an important role in antibody development. During the development of antibody drugs, quality control is carried out throughout to ensure the consistency, stability and safety of the products. Strict implementation of quality control helps to improve the quality, reliability and reproducibility of antibody drugs and ensure their safety and efficacy in clinical applications.
Bioactivity Evaluation: In Vitro Functional Assay
In vitro functional assays in bioactivity evaluation are designed to assess the biological activity of substances within controlled laboratory conditions, mimicking cellular environments outside of living organisms. These assays measure specific functional responses, such as enzyme activity, receptor binding, or cell signaling pathways, providing valuable insights into the substance's mechanisms of action and potential therapeutic applications.
- Target Proteins
- Multiple Species Target Proteins
- Inhibitor Screening Kits
- ComboX: Streptavidin Series Products
- ComboX: Universal Antibodies
- ComboX: Isotype Controls
- SPR/BLI Analytical Service
- CMC Release Method Development Service-ELISA
Bioactivity Evaluation: Mechanism of Action
Bioactivity evaluation involves assessing the interactions between a substance and biological systems to elucidate its mechanism of action, often employing assays or tests to determine its effects on cellular pathways or organisms. Understanding the bioactivity provides crucial insights into how a compound functions within living systems, aiding in the identification and development of potential therapeutic agents or elucidating their role in biological processes.
- Target Proteins
- Cytokines for Cell Culture (Premium Grade)
- T cell Activation/Expansion Reagents (Premium Grade)
- Cytokine Detection ELISA Kits
- ComboX: Isotype Controls
Immunological Activity Evaluation: Affinity
Immunological activity evaluation assesses the affinity of a substance, such as an antibody, antigen, or immunogen, towards specific targets within the immune system, gauging its binding strength or interaction with receptors or molecules. Determining the affinity in immunological activity aids in understanding the strength and specificity of immune responses, crucial for designing effective vaccines, therapies, or diagnostic tools.
- Fc Receptor Proteins
- SPR/BLI Affinity Analysis Services
Antibody Immunological Activity Detection: Cell Lines
Cell lines play a pivotal role in antibody immunological activity detection by serving as reliable models to assess the specificity and functionality of antibodies. These specialized cell systems enable the evaluation of antibody-antigen interactions, offering valuable insights into binding kinetics, potency, and selectivity, essential for characterizing their immunological activity.
- Overexpression Cell Lines
- Reporter Cell Lines
Structural and Thermal Stability Analysis
Protein structural and thermal stability analysis involves studying the conformational integrity and resistance to temperature-induced changes in proteins, elucidating their folding patterns and stability under varying environmental conditions. These assessments aid in understanding protein function, guiding drug design, and optimizing biotechnological processes by identifying conditions that maintain protein integrity and activity.
- Enzymes for Antibody Characterization
- SEC-MALS & UNcle Quality Characterization Analytical Service
Safety Evaluation: Residue Detection
Safety evaluation through residue detection involves the meticulous identification and measurement of potentially harmful remnants or byproducts of substances in various matrices, ensuring compliance with safety standards and regulations. This process aims to ascertain the absence or acceptable levels of residues, guaranteeing the safety of food, pharmaceuticals, or environmental samples for human or animal consumption or exposure.
- Residual Host Cell DNA / RNA Detection Kits
- Nuclease Residue Detection Kits
- Residual Antibiotics Detection Kits
Preclinical Studies
- Preclinical Studies
- Preclinical Model Selection
- Efficacy Evaluation: Pharmacodynamic Studies
- Efficacy Evaluation: Pharmacokinetic Studies
- Safety Evaluation: Toxicity
- Safety Evaluation: Immunogenicity Studies
- Efficacy & Safety Evaluation: Companion Diagnostics
Preclinical Studies
In preclinical drug development, accurate and reliable results are crucial to minimize clinical research risks. Animal experiments play a key role, considering factors such as drug MOA, target affinity, sequence and protein level consistency, and cellular considerations. Specificity and affinity of antibodies to different targets are also important considerations.
Preclinical Model Selection
Preclinical model selection involves choosing appropriate animal or cell-based models that closely mimic human physiology and pathology to study the efficacy and safety of new drugs or therapies. Careful consideration of these models is crucial for predicting human responses accurately, guiding researchers toward more reliable outcomes during preclinical testing phases.
- Multiple Species Target Proteins
- Pre-formed Fibrils (Aneuro)
- SPR/BLI Analytical Service
Efficacy Evaluation: Pharmacodynamic Studies
Pharmacokinetic studies also contribute to safety evaluation and clinical trial design. Typically, promising new antibody drugs are tested in laboratory cells to measure toxicity and efficacy before being tested in animals and humans.
- Cytokines for Cell Culture (Premium Grade)
- T cell Activation/Expansion Reagents (Premium Grade)
- Cytokine Detection ELISA Kits
- Pre-formed Fibrils (Aneuro)
- Diagnostic Biochips
Efficacy Evaluation: Pharmacokinetic Studies
Pharmacokinetics (PK) involves quantitatively analyzing how drugs are absorbed, distributed, metabolized, and excreted in living organisms. In preclinical and clinical studies, drug concentration in serum is measured after administration to assess pharmacokinetic properties and guide dosing recommendations.
- Target Proteins
- Biotinylated Target Proteins
- ELISA Assay Kits for Quantitative Analysis
- ComboX: Streptavidin Series Products
- ComboX: Universal Antibodies
- ComboX: Isotype Controls
- Anti-idiotype Antibodies
- PK Method Development, Validation and Transfer, Kit Development Services
Safety Evaluation: Toxicity
Toxicity assessment in safety evaluation involves analyzing the harmful effects or potential risks a substance poses to biological systems, determining its adverse impact on cells, organs, or organisms. This critical analysis aims to establish safe exposure levels and guidelines, ensuring the protection of human health and the environment from detrimental effects caused by the substance.
- Cytokines for Cell Culture (Premium Grade)
- Cytokines for Organoid Culture
- Matrigengel Matrix Basement Membrane Extracts
Safety Evaluation: Immunogenicity Studies
Immunogenicity studies in safety evaluation investigate the potential of a substance to provoke an immune response within a biological system, assessing the generation of antibodies or immune reactions against the substance. These studies are crucial in determining the safety profile of therapeutic drugs or biologics, ensuring they do not elicit harmful immune reactions that could compromise their efficacy or safety in patients.
- Target Proteins
- Biotinylated Target Proteins
- ComboX: Streptavidin Series Products
- ComboX: Universal Antibodies
- ComboX: Isotype Controls
- Anti-idiotype Antibodies
- Anti-idiotype Antibody Development Services, Immunogenic Reagents, and Kit Development Services
Efficacy & Safety Evaluation: Companion Diagnostics
Companion diagnostics play a pivotal role in efficacy and safety evaluation by identifying biomarkers that assist in predicting a patient's response to a specific treatment. These tests enable personalized medicine approaches, allowing healthcare providers to tailor therapies to individual patients, enhancing efficacy while minimizing potential safety concerns.
- Immunohistochemical (IHC) Antibodies
- Immunohistochemical(IHC) Kits
Clinical Studies
- Clinical Studies
- Efficacy Evaluation: Pharmacokinetic Studies
- Safety Evaluation: Toxicity Studies
- Safety Evaluation: Immunogenicity Studies
- Efficacy & Safety Evaluation: Companion Diagnostics
Clinical Studies
Clinical studies, or clinical trials, are research investigations conducted in humans to evaluate the safety and effectiveness of medical interventions. Clinical studies follow strict protocols and ethical guidelines, involving researchers, healthcare professionals, and regulatory oversight. They are vital for advancing medical knowledge and determining the safety and efficacy of interventions before widespread use.
Efficacy Evaluation: Pharmacokinetic Studies
Pharmacokinetics (PK) involves quantitatively analyzing how drugs are absorbed, distributed, metabolized, and excreted in living organisms. In preclinical and clinical studies, drug concentration in serum is measured after administration to assess pharmacokinetic properties and guide dosing recommendations.
- Biotinylated Target Proteins
- ComboX: Streptavidin Series Products
- Anti-idiotype Antibodies
- PK Method Development, Validation and Transfer, Kit Development Services
Safety Evaluation: Toxicity Studies
Toxicity assessment in safety evaluation involves analyzing the harmful effects or potential risks a substance poses to biological systems, determining its adverse impact on cells, organs, or organisms. This critical analysis aims to establish safe exposure levels and guidelines, ensuring the protection of human health and the environment from detrimental effects caused by the substance.
- CytokineDetection ELISA Kits
Safety Evaluation: Immunogenicity Studies
Immunogenicity studies in safety evaluation investigate the potential of a substance to provoke an immune response within a biological system, assessing the generation of antibodies or immune reactions against the substance. These studies are crucial in determining the safety profile of therapeutic drugs or biologics, ensuring they do not elicit harmful immune reactions that could compromise their efficacy or safety in patients.
- Biotinylated Target Proteins
- ComboX: Streptavidin Series Products
- ComboX: Universal Antibodies
- ComboX: Isotype Controls
- Anti-idiotype Antibodies
- Anti-idiotype Antibody Development Services, Immunogenic Reagents, and Kit Development Services
Efficacy & Safety Evaluation: Companion Diagnostics
Companion diagnostics play a pivotal role in efficacy and safety evaluation by identifying biomarkers that assist in predicting a patient's response to a specific treatment. These tests enable personalized medicine approaches, allowing healthcare providers to tailor therapies to individual patients, enhancing efficacy while minimizing potential safety concerns.
- Immunohistochemical(IHC) Antibodies
- Immunohistochemical(IHC) Kits
Resources
Therapeutic Antibody Tools & Solutions
Unlock the potential of Therapeutic Antibody Tools & Solutions by downloading our comprehensive brochure. Explore cutting-edge advancements, innovative technologies, and tailored solutions designed to accelerate therapeutic antibody development. Elevate your understanding of antibody-related therapies and empower your journey towards impactful healthcare solutions.
Resource Center
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Resources
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- Background
- Discovery & Development
- CMC-Manufacturing
- CMC- Quality Control
- Preclinical Studies
- Clinical Studies
- Resources