Apollo Biologics

Apollo Biologics has extensive experience with successful submissions for several marketed products in therapeutic areas of oncology, obesity and diabetes, immunology and biosimilars. We possess a deep understanding of current regulatory requirements for biologics (mAbs, peptides, conjugates, and viral-based drug products) includes experience with preparation and review of many successful filings (IND through BLA) and multiple face to face discussions with global health authorities. The firm has expertise in design, development, validation, and troubleshooting of many analytical and bioanalytical assay formats including those for purity, residuals, potency, biomarkers, anti-drug antibodies, and PK. GLP and GMP compliance and third-party contractor oversight.