The bioanalytical lab at Ology Bioservices has significant experience developing and working with biologic products, including biosimilars, vaccines, and biomarkers in different therapeutic areas.
Our scientists have over 10 years of experience in bioanalytical method development, validation, and sample testing dedicated to biologics development in contract research organization (CRO) environments and pharmaceutical industries. We work collaboratively to effectively meet Sponsors’ requirements of accurate, timely, and high-quality data.
We have Standard Operating Procedures (SOPs) in place to ensure compliance with good laboratory practice (GLP) and good clinical laboratory practice (cGLP) standards as well as current regulatory guidelines.
Ology Bioservices has successfully completed Department of Defense (DOD) inspection for multiple biodefense programs proving our deep understanding of regulatory guidelines, and demonstrating quality and integrity of our nonclinical and clinical bioanalytical data.
Each of our highly dedicated and knowledgeable team members have greater than 10 years of experience in CRO and/or pharmaceutical/biotechnology industries. We have expertise in developing and validating ligand-binding assays for biotherapeutics and biomarkers, to provide support from early development to pre-clinical, and clinical studies. With attention to detail and result oriented focus our scientists routinely develop, transfer, optimize and validate ligand binding assays to meet and exceed Sponsor’s requirements.
Ology Bioanalytical lab offers comprehensive bioanalytical services to support pharmacokinetic (PK), pharmacodynamic (PD), and anti-drug antibody (ADA) safety assessments. We have broad biopharmaceutical experience with a variety of large molecules including monoclonal and multivalent antibodies, antibody fragments, proteins and antibody drug conjugates (ADCs).
- Custom method development
- Method transfer of proprietary assays and optimization
- Commercial kit qualification
- Assay development and validation under GLP and/or GCLP regulations
- PK/PD ligand-binding methods
- Immunogenicity/ADA assays (screening, confirmation, titration, and assessment of neutralizing antibody (NAb))
- PK/PD/ADA sample analysis supporting nonclinical and clinical studies
- Study sample handling and management, as well as long-term matrix stability
- MSD® SQ120 reader
- Molecular Devices M2 and SpectraMax 384 readers installed with Softmax Pro GxP
- Biosafety Cabinets
- 96-well Plate Shakers
- 96-well Plate Washers
- Dedicated Control Temperature Chambers (2-8°C, -20°C, and -70°C)
- Method development, feasibility, and validation
- Nonclinical toxicokinetic (TK) studies
- Pharmacokinetic (PK) studies
- Pre-clinical and clinical sample analysis and reporting
- Immunogenicity / Anti-Drug Antibody (ADA) assays
- PD biomarkers
- Singleplex and Multiplex Assays
- Meso Scale Discovery® (MSD®) Technology – MSD ECL
- To be highly responsive
- To keep you, our Sponsors, well informed on the progress of your studies
- To provide fast turn-around time
- To provide the highest quality data
- To earn your trust as the most reliable drug development partner