Bioanalysis1
Whether your focus is small molecules, protein biotherapeutics, vaccines, gene therapy or cell therapy, QPS provides a full range of bioanalytical services to support all of drug development needs from discovery, through clinical development and regulatory filing.
Our dedicated, experienced team ensures that drug quantitation studies meet all timelines and regulatory requirements. QPS provides high quality data along with direct access to our technical staff, regularly scheduled updates in a format that works for you, and prompt and courteous answers to your inquiries at a fair and competitive prices. Our scientists come from a variety of backgrounds and can confidently perform the pharmacokinetic (PK), biodistribution, pharmacodynamic (PD), immunogenicity assessment, biomarker evaluation or pharmacogenomics (PGx) experiments required by the study protocols.
At QPS, translational medicine brings together leading-edge technologies and pharmaceutical research and development (R&D) experience to create a business service unit that works efficiently to advance your drug development program.
QPS maintains four advanced bioanalytical facilities in the USA, Netherlands, Taiwan, and India, offering strategic solutions to companies with sites or trials overseas and/or wishing to complete studies in Asia and/or India. All our facilities are geared for bioanalysis of samples containing up to biosafety level 2 (BSL 2) agents, such as human immunodeficiency virus (HIV), Hepatitis virus A, B, C, D, and E (HAV, HBV, HCV, HDV, HEV), influenza virus, coronavirus (SARS CoV, MERS CoV, SARS CoV 2),… Benefit from the worldwide resources that a bioanalytical contract research organization brings, including a portfolio of assays to cover your entire global demand in bioanalysis for your clinical studies.
Method Development
QPS 作为生物分析合同研究组织与您合作，在最合适的技术平台上开发检测方法。 Prior to starting any method development, we review and discuss with you the assay requirements and intended use, such as:
- Lead Optimization vs. Candidate Selection vs. Regulated Bioanalysis
- Ultra-high-performance liquid chromatography–mass spectrometry (UPLC MS/MS) for small molecule drug candidates and their potential metabolites
- Ligand Binding Assay (LBA) or hybrid UPLC MS/MS for peptide and protein drugs
- Hybridization LBA or hybridization HPLC fluorescence or UPLC coupled to high-resolution mass spectrometry (UPLC HRMS) or UPLC-MS/MS or HPLC ultraviolet (UV) for oligonucleotide based drugs
- Reverse Transcription – Quantitative Polymerase Chain Reaction (RT qPCR/qPCR) for mRNA (biotherapeutics and viral or plasmid vectors)
Our staff has considerable experience with conventional matrices (plasma, serum, whole-blood, urine, feces), as well as various animal and human tissues for biodistribution or potential target organ penetration or toxicity.
Regulated Bioanalysis
QPS complies with Good Laboratory Practice (GLP) regulations and guidance documents of the U.S. Food and Drug Administration (US FDA), the Organization for Economic Co-operation and Development (OECD), the National Medical Products Administration in China (NMPA), and Pharmaceuticals and Medical Devices Agency in Japan (PMDA) as required, and incorporates global GLP principles and regulations to improve chances of a successful submission and smooth the way for regulatory acceptance.
QPS builds robust assays for regulated bioanalysis that are validated in accordance with regulations. Once the methods, data, and results have been verified, a Quality Assurance Statement is included in every final report.
Links to Relevant Documents
领导者
Forming strategic relationships with today’s leading pharmaceutical companies requires a consistent record of client satisfaction, scientific leadership and proven results. QPS brings all of these pillars, plus a foundation of integrity and stewardship, to every partnership.
