To ensure the successful development of Antibody-Directed Enzyme Prodrug Therapy (ADEPT), Creative Biolabs conducts a comprehensive analysis of the physicochemical properties to evaluate the safety, stability, and efficacy of the antibody drug. Meanwhile, through systematic solubility testing, we can identify the optimal formulation to enhance the drug's bioavailability. More importantly, improving solubility can significantly enhance the drug's absorption and distribution properties.

Introduction

During the ADEPT discovery, physicochemical properties have emerged as key factors influencing therapeutic efficacy. The stability and solubility of antibodies are important for their effectiveness in vivo. A systematic analysis of these properties allows for the assessment of antibody stability under various conditions, facilitating formulation optimization and enhancing drug reliability. Furthermore, studying the interactions between antibodies and their targets helps to elucidate binding kinetics and thermodynamic properties, which can improve drug specificity and minimize side effects on healthy tissues. Additionally, analysis of physicochemical properties can provide valuable guidance for the antibody production process. Understanding aspects such as aggregation behavior, viscosity, and other physical characteristics can optimize manufacturing processes, increase yield, and reduce costs.

At Creative Biolabs, our services encompass a comprehensive analysis of antibody drugs, including aspects such as molecular weight, solubility, stability, hydrophilicity, and hydrophobicity. Utilizing advanced instruments and a skilled research team, we can deliver precise data and insightful analyses to assist you in optimizing drug structures, enhancing targeting capabilities, and improving therapeutic efficacy.

Fig.1 Lipids Chemical and Physical During Cytokinesis.^1,3

Services

Creative Biolabs provides a range of services to guarantee the efficacy and safety of pharmaceuticals, with physicochemical property analysis being a crucial area of focus. Our analysis not only helps clients gain a full understanding of the fundamental characteristics of their drugs but also offers essential data support for the subsequent ADEPT development and optimization.

• Solubility and Stability Testing Services
  - Creative Biolabs evaluates the solubility of antibody drugs to ensure effective dissolution under physiological conditions.
  - Our laboratory offers accelerated stability testing to analyze the degradation rate of drugs and their stability, allowing clients to predict the performance of antibody drugs under various storage conditions.
• pKa Value Determination Services
  - Our team can determine the acid-base dissociation constant (pKa) of antibody drugs, aiding in the understanding of their ionization characteristics under different pH levels, which can influence their bioavailability and absorption properties.
• Molecular Weight and Peptide Composition Analysis Services
  - Our research team employs techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS) to analyze the molecular weight, amino acid sequence, and modification status of antibodies, ensuring drug consistency and specificity.
• Conformational Analysis Services
  - Creative Biolabs assesses the secondary and tertiary structures of antibodies using techniques like circular dichroism (CD) and infrared spectroscopy to monitor the stability of their spatial conformation.
• Drug Interaction Studies
  - We can evaluate the interactions between antibody drugs and their targets, as well as other biomolecules, including binding affinity, kinetics, and potential competitive inhibition effects.
• Surface Characterization Analysis Services
  - Utilizing techniques such as dynamic light scattering (DLS) and atomic force microscopy (AFM), we analyze the surface characteristics of drugs to assess their behavior at the cellular level.

Fig.2 The Physical and Chemical Properties Analysis.^2,3

Case Study

Currently, Creative Biolabs has undertaken a project focused on the ADEPT development targeting specific tumors. As part of this effort, our team has conducted a comprehensive series of analyses on the physical and chemical properties to ensure the safety and efficacy of the ADEPT.

During the sample preparation process, we extracted antibodies from a recombinant protein expression system and concentrated them to an appropriate level using ultrafiltration technology. Simultaneously, we employed centrifugation to remove any precipitates, ensuring the purity of the samples to prevent interference with subsequent analyses. Next, size-exclusion chromatography (SEC) was utilized to assess the molecular weight and aggregation status of the antibodies, enabling us to accurately determine the molecular weight and degree of polymerization through comparison with standard molecular weights.

In addition, we prepared buffers at varying pH levels to evaluate the solubility of the antibodies, using a colorimetric method to track changes in antibody concentration across different pH values. To assess the stability of the antibodies, HPLC was employed to analyze their chemical stability under different temperatures and storage durations, allowing us to identify degradation products. We also conducted accelerated stability tests and long-term stability studies to ensure that no denaturation occurred.

Furthermore, we used UV-visible spectroscopy to investigate the spectral characteristics of the antibodies, assessing the specific absorbance and refractive index. This data, combined with dynamic light scattering (DLS) techniques, provided insights into the particle size distribution in solution, shedding light on aggregation behavior. Finally, we evaluated the thermal stability of the antibodies using thermogravimetric analysis (TGA) and differential scanning calorimetry (DSC), documenting changes in thermal decomposition temperatures and residues, as well as analyzing phase transition characteristics at varying temperatures.

Features

• Advanced Technology Utilization: Creative Biolabs typically employs state-of-the-art analytical instruments and techniques to ensure the precision and reliability of data. By integrating artificial intelligence and data mining technologies, they enhance the efficiency of their analyses.
• Tailored Services: Creative Biolabs offers customized analytical solutions based on the specific needs of their clients, ensuring that research remains focused and effective.
• Interdisciplinary Collaboration: Creative Biolabs often consists of multidisciplinary teams featuring experts from biochemistry, pharmacology, and medicinal chemistry, which ensures comprehensive and in-depth project execution.
• Accelerated Development Process: Our efficient analysis of physicochemical properties significantly shortens the antibody development timeline, enabling rapid identification of the most promising antibody candidates and increasing the likelihood of success in ADEPT projects.

Our physical and chemical analyses provide precise characterization of antibody structures, including their folding and aggregation states. This structural consistency is essential during the ADEPT development process to ensure the safety and efficacy of each production batch. Also, by evaluating the affinity and selectivity of the antibody-target interactions, Creative Biolabs can refine the antibody design to enhance its targeting capabilities. This improved selectivity not only boosts the therapeutic effectiveness of ADEPT but also minimizes damage to normal cells, thereby reducing potential side effects. Feel free to contact us by calling our hotline or emailing our customer support team.

References

1. Kunduri, Govind, Usha Acharya, and Jairaj K. Acharya. "Lipid Polarization during Cytokinesis." Cells 11.24 (2022): 3977.
2. Han, Chengyu, Juan Li, and Jianglong Shen. "Study on the physical and chemical properties of lead passivating agent in soil." Scientific Reports 13.1 (2023): 18213.
3. Distributed under Open Access license CC BY 4.0, without modification.

For Research Use Only | Not For Clinical Use