Preclinical Development

T&T Scientific offer comprehensive range of high-quality products and services, with quick delivery to support your research, development, and manufacturing needs. The team at T&T Scientific has a wealth of expertise and experience in lipid nanoparticle and liposome formulation for drug delivery applications. T&T is well equipped with the operational capabilities and Quality Assurance team required to develop preclinical requirements and get to clinical and commercial batch manufacturing of formulations utilized in therapeutics and vaccines.

Preclinical and Technology Transfer for analytical method and manufacturing process development based on FDA Guidelines:
    • Analytical Method Development: Dynamic Light Scattering, Zeta Potential, Chromatography, and Stability
    • Troubleshooting and Process Development Analytical Support: Analytical Method Optimization
    • Method Qualifications and Validations
    • GMP Analytical Testing: API and Raw Material UPS Testing Per
    • Sterile Injectable In-Process and Finished Drug Product Testing
    • API, Raw Material, In-Process, and Finished Product Specification Development
    • Manufacturing Process Development and Scale Up
    • Pharmaceutical cGMP Compliant and ICH Stability and Degredation Testing and Storage
    • Complex Drug Product Testing for Lipid Nanoparticles & Pegylated Formulations Involving Antibodies, Peptides, Oligonucleotides, Proteins, Small & Other Large Molecules
    • Dedicated Development Team of Highly Experienced, Qualified and Trained Scientists
    • Dedicated Staff for cGMP & QC Routine Testing