Ology Bioservices, Inc. (Ology Bio) is a US based, biologics-focused, full-service contract development and manufacturing organization (CDMO). The company has over 250 passionate biopharmaceutical experts supporting industry and government partners in developing recombinant proteins, vaccines, viral vectors and monoclonal antibodies against life-threatening diseases. Ology Bio is headquartered at the 183,000 sq. ft. advanced development and manufacturing facility in Alachua, Florida, with laboratories at the 35,500 sq. ft. facility in Alameda, California and offices in Frederick, Maryland.
Ology Bio is a fully integrated company offering corporate expertise to every project, including regulatory support from pre-IND through licensure, project management services, and bioanalytical development and testing. Ology Bio has been awarded numerous US government contracts and grants for the advanced development and manufacturing of multi-antibody therapeutics, which to date have completed Phase I clinical trials.
“Ology Bio has extensive expertise in designing, developing, troubleshooting, and validating ligand-binding assays for pharmacokinetics, pharmacodynamics, and immunogenicity assessment in biotherapeutic programs”
Ology Bio’s Bioanalytical Services are located in Alameda, California, in the heart of the Bay Area Biotech Hub, where they advance strong collaborations with biotech firms in the region, and across the nation, to accelerate the pace of innovation. The Ology Bio Bioanalytical Services team has significant experience in the Biopharma industry in GLP- and GMP-regulated roles, developing quality products that meet the clients’ needs in a timely and compliant manner. The team has extensive expertise in designing, developing, troubleshooting, and validating ligand-binding assays for pharmacokinetics, pharmacodynamics, and immunogenicity assessment in biotherapeutic programs.
Ology Bio executes an integral project management strategy by employing a single ‘point of contact’ to manage internal and external stakeholder interactions and project expectations, while monitoring project progress. The Bioanalytical Services team maintains continual and collaborative communications by remote video-conferencing or in-person meetings either at the partner organizations or at Ology Bio’s Alameda facility, which supports critical data review, efficient validation, and implementation of methods for preclinical and clinical studies.
Ology Bio continues to advance support for their clients by implementing current methods in bioanalytical development and testing services. Looking forward, Ology Bio plans to add tagging and tracking of therapeutic modalities to their testing methods. With broad biopharmaceutical experience for a variety of large molecules including monoclonal and multivalent antibodies, antibody fragments, proteins, and antibody drug conjugates, Ology Bio offers:
- Method transfer and optimization
- Assay development and validation under good laboratory practice (GLP) regulations
- PK/PD ligand-binding methods
- Immunogenicity/ADA assays
- Screening, confirmation, titration, and assessment of neutralizing antibody
- PK/PD/ADA sample analysis supporting nonclinical and clinical studies
- Singlet and Multiplex Assays
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Electrochemiluminescence (ECL)