Biopharmaceuticals In Vivo Animal Studies Microbiology Testing Biopharmaceutical Characterization & Functional Assays Cellular & Molecular Lab Assays Acute toxicity studies Sub-acute and sub-chronic toxicity studies Chronic toxicity studies Maximum tolerated dose (MTD) determination Dose range finding (DRF) studies Pharmacokinetic (PK) and bioavailability studies Disease and efficacy models Repeated dose toxicity assessments Microbiology & Resistance Studies Sterility testing (per ISO, USP, or pharmacopeial standards) Bioburden determination and monitoring Endotoxin testing (Limulus Amebocyte Lysate, LAL) Antibacterial and antifungal activity assays Microbial identification / strain typing Resistance profile screening Environmental monitoring (surfaces, air, water) Preservative efficacy (challenge test) Cell-based & Functional Bioassays (Potency, Immunogenicity, Cytotoxicity) Mechanism of Action Studies (Receptor Binding, Signal Transduction) Molecular & Analytical Characterization (HCP, Residual DNA/RNA, Binding Studies) In Vitro ADME & Stability Studies (Serum/Plasma Stability, Permeability, Protein Degradation) Stability & Shelf-life Studies (Accelerated, Real-Time, Forced Degradation) Immunology & Bioanalytical Platforms (Cytokine Release, Immunophenotyping, PK/PD Analysis) Pathology, Microbiology & Virology Support (Histopathology, Sterility, Mycoplasma, Endotoxin Testing) Custom Assay Development & Validation Cytotoxicity Assays (MTT, XTT, LDH, WST-1, Neutral Red) Cell Proliferation and Apoptosis Studies Genetic Toxicology Tests (Ames Test, Micronucleus Assay, Chromosome Aberration) ADME Cellular Models (Caco-2 Permeability, Hepatocyte Metabolism) Reporter Gene Assays (Mechanism-of-Action) Flow Cytometry-based Immunophenotyping Custom Cell-Based Assay Development
