Traditional antibody-drug conjugates (ADCs) show significant effectiveness as cancer treatment agents. Their large molecular size restricts their ability to penetrate tumors effectively while simultaneously causing extensive systemic toxicity. Antibody fragment-drug conjugates (FDCs) represent a promising alternative for cancer therapy. FDCs offer substantial potential because their low molecular weight allows for quicker tumor penetration while reducing systemic toxicity. We recognize the obstacles you face during drug development including how to improve drug targeting methods, decrease toxicity levels and speed up the research process. Our comprehensive and professional FDC custom development services help you navigate challenges and advance innovative drug development.
Target Antigen Screening and Validation: Our expert team together with state-of-the-art equipment enables us to help you find and verify effective target antigens for antibody fragment-drug conjugates (FDCs). Our experimental approach includes both in vitro and in vivo studies to analyze antigen expression and specificity for accurate antibody fragment-drug conjugate development.
Antibody Engineering and Optimization: We employ specialized antibody engineering and optimization techniques to produce antibody fragments that exhibit superior affinity and improved drug conjugate stability along with advanced pharmacokinetic properties.
Linker Design and Synthesis: We create custom linkers tailored to project needs by optimizing their stability properties and cleavability potential as well as drug release kinetics for improved therapeutic outcomes.
Drug Conjugation: Our extensive drug conjugation expertise enables us to employ multiple conjugation chemistry techniques including thiol-maleimide, click chemistry and hydrazone conjugation for successful coupling of cytotoxic drugs with antibody fragments.
In Vitro and In Vivo Evaluation: Our team performs multiple in vitro and in vivo evaluations to study antibody fragment-drug conjugates for specificity and potency alongside pharmacokinetics which aids in selecting potential drug candidates and supports further advancement.
Process Development and Scale-Up: Our services cover both laboratory-scale and industrial-scale production processes with complete development solutions to maintain product quality consistency throughout different research and production phases.
Professional Technical Team: Our team consists of scientists with extensive experience and expertise in antibody engineering, medicinal chemistry, bioconjugation, and drug development. They are familiar with every step of the FDC development process, enabling us to provide comprehensive support from concept design to clinical trials.
Advanced Technological Platform: We are equipped with internationally leading technological devices and analytical instruments, such as high-throughput screening systems, mass spectrometers, HPLC, flow cytometers, etc., ensuring the accuracy and reliability of experimental data. Additionally, we have advanced platforms for antibody expression and purification, drug synthesis and conjugation, as well as in vitro and in vivo evaluation, providing solid technical support for efficient FDC development.
Rich Project Experience: Over the years, we have successfully completed numerous FDC development projects across a variety of disease fields and target types. These projects enable us to quickly respond to various technical challenges, optimize development processes, and improve project success rates, providing valuable reference and insight for your project.
Strict Quality Control: We prioritize quality, establishing a comprehensive quality management system to strictly control every stage of FDC development. From raw material procurement to final product delivery, each step undergoes rigorous testing and validation to ensure the FDC products meet the highest quality standards and regulatory requirements.
Flexible Cooperation Model: We offer flexible cooperation models, whether it's a complete FDC development project or technical services for specific stages. We can customize our services to meet your needs. We also provide technical consultation and training to help you understand the technical details and the latest advancements in FDC development.
Antibody Fragment Expression and Engineering Platform: We have an advanced platform for antibody fragment expression and engineering, enabling the efficient generation and optimization of various types of antibody fragments, such as Fab, scFv, sdAb, etc. Through genetic engineering, we can express antibody fragments in various host cells and make necessary modifications to enhance their stability and function.
Drug Conjugation Platform : Our drug conjugation platform uses various advanced conjugation techniques, such as site-specific conjugation, click chemistry, and enzyme-catalyzed conjugation, allowing for the efficient and precise coupling of drugs with antibody fragments. We also have an extensive library of linkers and drugs, which can be flexibly selected and synthesized based on project needs.
Analysis and Characterization Platform: We have a comprehensive analysis and characterization platform to fully assess the physicochemical and biological properties of FDCs. Our analytical techniques include mass spectrometry, HPLC, capillary electrophoresis, dynamic light scattering, and surface plasmon resonance, which can measure key parameters such as molecular weight, purity, stability, drug-antibody ratio (DAR), and binding affinity. In addition, we conduct in vitro cell activity tests, in vivo pharmacodynamics, and pharmacokinetics studies to ensure the therapeutic effect and safety of FDCs.
Cancer Therapy: FDCs have vast potential in cancer therapy. Due to their smaller molecular weight and faster tumor penetration, FDCs can more effectively deliver cytotoxic drugs to tumor cells, achieving precise targeting while reducing damage to normal tissues, thereby improving therapeutic efficacy and the patient's quality of life.
Immune Disease Treatment: FDCs can also serve as a novel targeted therapy for immune diseases, specifically binding to antigens on the surface of immune cells, modulating immune system function, and inhibiting excessive immune responses. This provides a treatment approach for autoimmune diseases, inflammatory diseases, and more.
Infectious Disease Treatment: FDCs show potential in treating certain infectious diseases. For example, by conjugating antiviral drugs with antibody fragments targeting viral surface antigens, FDCs can achieve precise recognition and efficient killing of viruses, providing a new strategy and method for antiviral therapy.
1. What are the advantages of FDCs over traditional ADCs?
FDCs have a smaller molecular weight, allowing for faster penetration into solid tumors, increasing tumor-to-blood ratios, and reducing systemic toxicity, thus improving the therapeutic index. Additionally, FDCs lack the Fc region, which means they do not trigger antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC), reducing potential side effects.
2. Do you offer customized FDC services?
Yes, we offer comprehensive, customized FDC services. Based on your specific needs and project objectives, we will work with you to design a personalized development plan, including target selection, antibody fragment design, linker and drug selection, and conjugation methods, ensuring our services meet your unique requirements.
3. How do you ensure the quality and stability of FDCs?
We have established a strict quality control system to monitor and test every stage of FDC development. From raw material quality inspection to final product purity, stability, and activity characterization, we use internationally advanced analytical techniques and equipment to ensure the FDC products meet the highest quality standards. Additionally, we perform stability studies under various conditions to evaluate the long-term storage and transport stability of FDCs.