Development and Validation

Development and Validation

At Protheragen-ING Lab, we specialize in providing comprehensive development and validation services for various pharmaceutical and biotechnology projects. Our team of experienced scientists and experts is dedicated to ensuring the successful development and validation of small molecules, large molecules, and analytical methods. With our expertise and cutting-edge facilities, we strive to deliver high-quality results that meet regulatory requirements and industry standards.

Fig.1 Development and Validation

Find out more about each of our services

  • Small Molecule Development
    Our small molecule development services encompass the entire drug discovery and development process. We work closely with our clients to design and synthesize novel compounds, optimize lead candidates, and develop robust synthetic routes.
    Our team is well-versed in medicinal chemistry, computational modeling, and structure-activity relationship studies, enabling us to deliver tailored solutions for your specific project needs. Additionally, we conduct extensive physicochemical characterization, formulation development, and preformulation studies to ensure the stability, solubility, and bioavailability of small molecule candidates.
  • Large Molecule Development
    Our large molecule development capabilities cover a wide range of therapeutic modalities, including monoclonal antibodies, recombinant proteins, peptides, and nucleic acids. We offer expertise in cell line development, upstream and downstream process development, and formulation optimization.
    Our scientists possess in-depth knowledge of expression systems, purification techniques, and analytical characterization, allowing us to deliver scalable and efficient manufacturing processes for large molecule therapeutics. We also provide support for comparability studies, process validation, and technology transfer to facilitate the successful transition from research to commercial production.

Fig.2 Large Molecule

  • Analytical Method Development and Validation Testing
    Our analytical method development and validation services ensure that your products meet the required quality standards and comply with regulatory guidelines. We have expertise in a wide range of analytical technologies, including chromatography (HPLC, GC), spectroscopy (UV-Vis, FTIR), mass spectrometry, and electrophoresis.
    Our team develops and validates methods for impurity profiling, content uniformity, dissolution testing, stability testing, and other essential parameters. We strictly adhere to regulatory guidelines such as ICH, and USP requirements, providing you with robust and validated methods that are essential for regulatory submissions and ongoing quality control.

Why Protheragen-ING Lab?

  • Regulatory Compliance - Our team is well-versed in regulatory requirements and can guide you through the complex landscape of drug development. We ensure that all our services are conducted in compliance with applicable regulatory guidelines, including Good Laboratory Practices (GLP).
  • Technology Platform - We leverage state-of-the-art technology platforms and equipment to support our development and validation services. Our advanced infrastructure enables us to perform high-throughput screening, process optimization, and data analysis with efficiency and accuracy.
  • Quality Assurance - We have implemented rigorous quality assurance processes, including regular audits, documentation control, and adherence to standard operating procedures (SOP). Our commitment to quality ensures the reliability and integrity of our development and validation services.
  • Collaborative Approach - We believe in fostering strong partnerships with our clients. We actively engage in collaborative discussions, providing regular updates and seeking input to ensure that our services align with your specific goals and requirements.

Contact us today to discuss how our services can support your specific requirements and contribute to your success in the pharmaceutical market.