QPS Holdings, LLC

COVID-19 vaccine developments

Peek behind the paper: how ADA methodology informs SARS-CoV-2 assay development

Ask the Experts – hybrid LBA/LC–MS

Brexit or not, the drug research and development landscape has changed

Ask the Experts: outsourcing

Hybrid LC–MS assays reaching standards for regulatory filings

Expert advice to young scientists

QPS expands their translational medicine capabilities at flagship facility in Delaware

QPS White Paper – Three lessons to help accelerate pharmaceutical breakthroughs for CNS disorders

Panel discussion: developments in the oligonucleotide field

Panel discussion: FDA guidance, transitioning skills and future hopes for the bio lab

Business of bioanalysis: season two

The changing world of bioanalysis panel discussion

Business of bioanalysis: Bioanalysis Zone panel discussion

Bioanalysis Zone Panel Discussion

QPS Awarded Two 2020 CRO Leadership Awards

QPS Continues to Expand UPLC-HRMS Quantitation Capabilities to Support Gene Therapy and Protein Drug Development

QPS Announces Novel Coronavirus/COVID-19 Testing Capability

QPS Assembles an Access Restricted Bioanalysis Lab to Support Drug Companies in the Fight Against Novel Coronavirus

QPS Forms Partnership with UMCG and G-CURE for Cardiovascular Drug Development

Three Common Site Selection Mistakes

QPS Outpaces Market Growth for Phase I Clinical Trials, Adopts ClinSpark to Support Rapid Global Expansion

Brexit Leads to 25 Percent Decline in UK Clinical Trials: QPS Netherlands Ready to Take on Clinical Trials that Require Relocation, Manage New Projects

QPS Expands Translational Medicine Unit Three-Fold to Increase Support for Biopharmaceutical, Biotechnology and CRO Partners, Address Market Demand for Gene Therapy

QPS Announces Launch of New Brand Identity, Celebrates 24 Years of Growth

View a full list of upcoming conferences QPS are attending here

EBF

Hear from a QPS Expert:

• 18 November 2020 Day 2 from 14:30-14:50 Fabrizia Fusetti, PhD will discuss Hybrid LC-MS assays for clinical development.

Fabrizia Fusetti, PhD Presents: “Development and validation of a Trastuzumab/Pertuzumab Hybrid LC-MS assay for clinical development”

Fabrizia Fusetti is the Scientific Director Bioanalysis at QPS Netherlands. Fabrizia obtained her PhD in Molecular Biology and Biotechnology at the University of Milan (Italy), after which she spent several years in academia and participated in numerous undamental and applied research projects mainly focused on the study of proteins. Her work contributed to over 50 peered reviewed publications. Before joining QPS in 2014, she started and managed one of the proteomics platforms at the University of Groningen. She is particularly interested in the development of mass spectrometry methods for bioanalysis of recombinant proteins, antibodies, ADCs, peptides and oligonucleotides.

The need for multiplex PK assay is growing together with the increasing use of multiple monoclonal antibodies (mAbs) in combination therapies. For the frequently co-administered anti-Human Epidermal growth factor Receptor 2 (HER2) mAbs trastuzumab and pertuzumab we developed a high-throughput and robust hybrid ligand-binding LC–MS/MS quantitative method. Nanomolar concentrations of trastuzumab and pertuzumab were determined after extraction by protein A affinity purification followed by trypsin digestion. The method, validated according to the current FDA/EMA guidelines for large molecule bioanalysis, was accurate and selective for the simultaneous determination of trastuzumab and pertuzumab in clinical samples, thereby overcoming the limitation of ligand binding assays that are challenged by mAbs targeting the same receptor. The assay was applied to support a late phase clinical study investigating the addition of co-administered trastuzumab and pertuzumab to standard curative treatments in esophageal cancer patients. The described generic bioanalytical strategy can easily be adapted to multiplex quantifications of other mAb combinations in non-clinical and clinical samples1.

1. Schokker, S, Fusetti, F, Bonardi, F, Molenaar, RJ, Mathôt, RAA, van Laarhoven, HWM, (2020) Development and validation of an LC-MS/MS method for simultaneous quantification of co-administered trastuzumab and pertuzumab. mAbs 12 (1), 1795492.

Posters:

• Martijn Hilhorst, PhD, Director LC-MS Small and Large Molecules, Presents: “Strategies for the prevention of non-specific binding in the quantitative determination of drugs in cerebrospinal fluid”
• Chris Williams, PhD, Study Director Large Molecule LC-MS, Bioanalysis & Drug Metabolism, Presents: “Development of a hybrid method for simultaneous quantification of two near identical proteins in plasma”

Springfield (Missouri, USA) Organizations to Start COVID-19 Vaccine Trials

Applications open for COVID-19 vaccine trials at QPS in Springfield, Missouri

QPS in Springfield, Missouri to help in quest for COVID-19 vaccine

QPS Missouri, USA, is currently running COVID-19 clinical trials

QPS: Helping Pharma Companies Develop Better Drugs

Gronings lab onderzoekt medicijn dat de symptomen van het coronavirus aanpakt: ‘De eerste signalen zijn hoopvol’

Statewide COVID-19 Testing Plan Could Become a Reality

Treasure Coast attorneys: Prisoners could be saving grace in race for COVID-19 cure

QPS Assembles An Access Restricted Bioanalysis Lab To Support Drug Companies In The Fight Against Novel Coronavirus

Five Strategies for Conducting Successful Pediatric Trials,” has published in Applied Clinical Trials

QPS has expanded its Phase I clinical trial capabilities by more than 20% and doubled its lab space, which will allow the CRO to accommodate ‘exponentially more sponsors’ as demand continues to increase

QPS is expanding ‘aggressively’ at its US-based headquarters, rebuilding on a rolling basis to support a growing demand for gene therapy treatments, says VP

QPS Announces Launch of New Brand Identity, Celebrates 24 Years of Growth

QPS Expands Translational Medicine Unit Three-Fold to Increase Support for Biopharmaceutical, Biotechnology and cRO Partners, Address Market Demand for Gene Therapy

Clinical trials in the UK are reportedly declining as the country grapples with Brexit – a change which could make access to preclinical and bioanalytical research materials, including NHPs, problematic, says QPS