Macromolecule Developability Analysis and Method Development

Macromolecule Developability Analysis and Method Development

Macromolecular drugs, such as monoclonal antibodies, fusion proteins, and nucleic acid drugs, are rapidly becoming the centerpiece of modern biopharmaceuticals. However, these complex biomolecules face a number of challenges during their development, from their biophysical and chemical stability to their biological activity and immunogenicity.

To ensure that these biopharmaceuticals make it to clinical development and the marketplace, Protheragen-ING Lab provides comprehensive exploitability analysis and method development services to help clients overcome these challenges and advance large molecule drugs from R&D to commercialization.

Protheragen-ING Lab's developability analysis services

Exploitability analyses are a critical step in evaluating the risks and issues that a biological drug may face during the development process. These analyses help determine the chemical and physical properties of a drug, predict its stability in storage, transport and use, and evaluate its behavior in biological systems.

Our exploitable analytical services include, but are not limited to, the following:

  • Physicochemical property assessment: including solubility, pH stability, thermal stability, aggregation tendency, etc.
  • Structural analysis: molecular structure characterization using techniques such as high-resolution mass spectrometry, nuclear magnetic resonance (NMR), and X-ray crystallography.
  • Stability testing: Evaluate the stability of drugs under different conditions through accelerated and long-term stability tests.
  • Immunogenicity assessment: Predicting and evaluating the immunogenicity of drugs to help reduce the risk of potential immune reactions.

Protheragen-ING Lab's method development services

Successful biopharmaceutical development relies on reliable and reproducible methods that accurately measure and control the quality, purity, and potency of drugs. Our method development services are dedicated to providing high-quality support for the analysis and manufacture of large-molecule drugs, ensuring compliance with industry standards and regulatory requirements at every step.

Our method development services include, but are not limited to:

Analytical method development

  1. High-Performance Liquid Chromatography (HPLC) - for purity, potency, and impurity analysis.
  2. Capillary Electrophoresis (CE) - for protein size and charge variation analysis.
  3. Mass Spectrometry (MS)-for molecular weight determination and structural characterization.
  4. Enzyme-linked immunosorbent assay (ELISA) - for potency and immunogenicity testing.

Manufacturing Process Development

  • Cell culture processes: optimization of cell lines and culture conditions to improve yield and quality.
  • Purification processes: development and optimization of purification strategies such as protein A affinity chromatography, ion exchange chromatography, and hydrophobic chromatography.
  • Formulation development: develop stable drug formulations to ensure drug stability and availability.

Quality Control Methods

  • Quantitative PCR (qPCR): for gene expression analysis and residual DNA detection.
  • Bioactivity assays: Development of functional assays based on cellular and molecular levels.

Service advantages of Protheragen-ING Lab

  • Advanced technology platform - equipped with the most advanced analytical and manufacturing equipment to ensure high precision and reliability.
  • Professional R&D team - a team of experts with multidisciplinary backgrounds, capable of providing customized solutions.
  • Strict quality management - following GLP standards to ensure the quality and compliance of each project.
  • Comprehensive range of services - from early R&D to the clinical stage, we support customers' drug development needs in all aspects.

Protheragen-ING Lab has helped several biopharmaceutical companies successfully develop and commercialize a variety of large-molecule drugs. If you are in the process of developing a large molecule drug and need professional developability analysis and method development services, please contact us. We are committed to being your trusted partner in the development of biopharmaceuticals and working together to advance science for the benefit of patients worldwide.