Apollo Biologics provides consultation on biologics drug development, including Bioanalytical and anti-drug antibodies, CMC Biologics, regulatory strategy, and due diligence.
Apollo Biologics has extensive experience with successful submissions for several marketed products in therapeutic areas of oncology, obesity and diabetes, immunology, and biosimilars.
Founder Constance (Connie) Cullen, Ph.D. has over 20 years experience in all aspects of drug development. She has successfully worked with both large Pharma and small biotech and understands the unique needs of each.
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.
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.
Founder Constance (Connie) Cullen, Ph.D.