Apollo Biologics
Apollo Biologics specializes in biologics drug development consultation, including bioanalytical and anti-drug antibodies, CMC, regulatory strategy, and due diligence. With extensive experience in successful submissions across therapeutic areas such as oncology, obesity, diabetes, immunology, and biosimilars, the company offers expertise in assay design, validation, and troubleshooting, ensuring compliance with GLP and GMP standards. Led by founder Dr. Constance Cullen, who has over 20 years of drug development experience, Apollo Biologics aims to support clients through all stages of biologics development and regulatory processes.
Industries
Nr. of Employees
small (1-50)
Apollo Biologics
Westlake Village, California, United States
Products
Bioanalytical Assay Services
Design and validate bioanalytical assays for drug levels, anti-drug antibodies, target engagement, and biomarkers with GLP compliance and contractor oversight.
Regulatory Strategy Services
Design and execute successful and phase-appropriate regulatory strategy, prepare and review submissions from Phase I through BLA and post-marketing commitments.
CMC Biologics Services
Assay design development and validation of all release testing, characterization assays, and cell-based potency assays alongside CMO/CRO oversight and team leadership.
Due Diligence Support
Discreet and confidential due diligence support whether for potential in-license/acquisition opportunities or preparation to host out-license due diligence.
Bioanalytical Assay Services
Design and validate bioanalytical assays for drug levels, anti-drug antibodies, target engagement, and biomarkers with GLP compliance and contractor oversight.
Regulatory Strategy Services
Design and execute successful and phase-appropriate regulatory strategy, prepare and review submissions from Phase I through BLA and post-marketing commitments.
CMC Biologics Services
Assay design development and validation of all release testing, characterization assays, and cell-based potency assays alongside CMO/CRO oversight and team leadership.
Due Diligence Support
Discreet and confidential due diligence support whether for potential in-license/acquisition opportunities or preparation to host out-license due diligence.
Services
Consulting to design and execute regulatory strategies and to prepare/review submissions from Phase I through BLA, and to manage post-marketing commitments.
CMC consulting for biologics including development and validation of release and characterization assays, cell-based potency assay support, and CMO/CRO oversight.
Design, development, validation, and GLP-compliance support for assays measuring drug levels, ADAs, target engagement, biomarkers, and PK; includes troubleshooting of assay formats.
Confidential due diligence assessments for in-license/acquisition opportunities or to prepare organizations for hosting out-license due diligence, with focus on biologics, CMC, and analytical capabilities.
Consulting to design and execute regulatory strategies and to prepare/review submissions from Phase I through BLA, and to manage post-marketing commitments.
CMC consulting for biologics including development and validation of release and characterization assays, cell-based potency assay support, and CMO/CRO oversight.
Design, development, validation, and GLP-compliance support for assays measuring drug levels, ADAs, target engagement, biomarkers, and PK; includes troubleshooting of assay formats.
Confidential due diligence assessments for in-license/acquisition opportunities or to prepare organizations for hosting out-license due diligence, with focus on biologics, CMC, and analytical capabilities.
Expertise Areas
- Regulatory strategy and submissions for biologics
- CMC development and release testing for biologics
- Bioanalytical method development and validation
- Anti-drug antibody (ADA) assessment and immunogenicity
Key Technologies
- Anti-drug antibody (ADA) immunoassays
- Bioanalytical immunoassays for drug levels
- Cell-based potency assays
- Biomarker assays
News & Updates
A new anti-drug antibody assay was developed and validated to address false positive issues caused by cross-linking through Factor XI in clinical trials for Abelacimab, a fully human IgG1 monoclonal antibody.
A new anti-drug antibody assay was developed and validated to address false positive issues caused by cross-linking through Factor XI in clinical trials for Abelacimab, a fully human IgG1 monoclonal antibody.