Embryonic Stem Cells
Pipetting Samples
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Pipetting Samples and Test Tube
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Apollo Biologics provides consultation on biologics drug development including Bioanalytical and anti-drug antibodies, CMC, regulatory strategy and due diligence.

ABOUT US

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.

Founder Constance (Connie) Cullen, Ph.D.

  • Apollo Biologics LinkedIn Profile
 

OUR SERVICES

Regulatory
Strategy
 
Work with your team to design and execute successful and phase- appropriate regulatory strategy, prepare and review submissions Ph I through BLA and post-marketing commitments.
CMC
Biologics
Assay design development and validation of all release testing, characterization assays, cell-based potency assays. CMO/CRO oversight, team leadership.
Design and validate bioanalytical assays for drug levels, anti-drug antibodies, target engagement, and biomarkers. Provide support with assay design, GLP compliance, and contractor oversight
Due Diligence
Discreet and confidential due diligence support whether for potential in-license/acquisition opportunities or preparation to host out-license due diligence.
 

Contact Us