Steve Lowes

Q2 Solutions (United States)

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Co-Authors

Fabio Garofolo

Angelini Pharma (Italy)

Richard B. Hayes

New York University

Laura Cojocaru

Covance (United States)

Robert I. Nicholson

Tenovus Cancer Care

Shane Karnik

University of Colorado Colorado Springs

Wei Garofolo

Grand Challenges Canada

Ronald E. Shoup

Indiana Biosciences Research Institute

Isabelle Dumont

Université du Québec à Montréal

Mario L. Rocci

Highways England

Jenny Lin

Sears Holdings (United States)

Cooperative Institutions

Pfizer (United States)

Bioanalytical Systems (United States)

Covance (United States)

BioPhage Pharma (Canada)

Bristol-Myers Squibb (United States)

Pharmaceutical Product Development (United States)

Bristol-Myers Squibb (Germany)

Eli Lilly (United States)

Novartis (Switzerland)

Merck & Co., Inc., Rahway, NJ, USA (United States)

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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

Bioanalysis (2014)

Dawn Dufield Hendrik Neubert Fabio Garofolo Leo Kirkovsky Lauren Stevenson

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

Bioanalysis

Biopharmaceutical

White paper

10.4155/bio.14.279

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Citations (50)

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

Bioanalysis (2009)

Natasha Savoie Fabio Garofolo Peter van Amsterdam Brian Booth Douglas M. Fast

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.

Bioanalysis

10.4155/bio.09.134

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Citations (88)

AAPS and US FDA Crystal City Vi Workshop on Bioanalytical Method Validation for Biomarkers

Bioanalysis (2016)

Steve Lowes Bradley L. Ackermann

Crystal City VI Workshop on Bioanalytical Method Validation of Biomarkers, Renaissance Baltimore Harborplace Hotel, Baltimore, MD, USA, 28-29 September 2015 The Crystal City VI workshop was organized by the American Association of Pharmaceutical Scientists in association with the US FDA to continue discussion on the bioanalysis of biomarkers. An outcome of the Crystal City V workshop, convened following release of the draft FDA Guidance for Industry on Bioanalytical Methods Validation in 2013 was the need to have further discussion on biomarker methods. Biomarkers ultimately became the sole focal point for Crystal City VI, a meeting attended by approximately 200 people and composed of industry scientists and regulators from around the world. The meeting format included several panel discussions to maximize the opportunity for dialogue among participants. Following an initial session on the general topic of biomarker assays and intended use, more focused sessions were held on chromatographic (LC-MS) and ligand-binding assays. In addition to participation by the drug development community, significant representation was present from clinical testing laboratories. The experience of this latter group, collectively identified as practitioners of CLIA (Clinical Laboratory Improvement Amendments), helped shape the discussion and takeaways from the meeting. While the need to operate within the framework of the current BMV guidance was clearly acknowledged, a general understanding that biomarker methods validation cannot be adequately depicted by current PK-centric guidelines emerged as a consensus from the meeting. This report is not intended to constitute the official proceedings from Crystal City VI, which is expected to be published in early 2016.

Bioanalysis

Panel discussion

10.4155/bio.15.251

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Citations (41)

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

The AAPS Journal (2014)

Brian Booth Mark E. Arnold Binodh DeSilva Lakshmi Amaravadi Sherri Dudal

Bioanalysis

Plenary session

10.1208/s12248-014-9696-2

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Citations (109)

Multiresidue analysis of sulfonamides using liquid chromatography with atmospheric pressure chemical ionization mass spectrometry

Rapid Communications in Mass Spectrometry (1993)

Daniel R. Doerge Steve Bajic Steve Lowes

Abstract Sulfonamide antibiotics are widely used to prevent bacterial infections in livestock, and residues are commonly found in milk and meat. This is of toxicological and regulatory concern because sulfamethazine produces thyroid tumors in rodents. Unadulterated milk was purified using solid‐phase extraction and six sulfonamides were added prior to analysis by liquid chromatography coupled to atmospheric pressure chemical ionization mass spectrometry. The mass spectra of all sulfonamides consisted exclusively of protonated molecules at low sampling cone voltage and, under these conditions, estimated detection limits were 0.05–0.5 ng, corresponding to 0.25–2.5 ppb in milk. The response curve for sulfamethazine was linear over a concentration range (1.25–20 ppb) that encompasses the regulatory level of interest in milk (10 ppb). Increasing the sampling cone voltage caused collision‐induced dissociation of sulfonamides that resulted in formation of ions that are diagnostic for the variable heterocyclic base and constant sulfanilyl portions of the molecule. At intermediate sampling cone voltages, multiple fragment ions were formed with reproducible intensity ratios. This process can be used to provide additional confirmation of target sulfonamides. Monitoring a common fragment ion formed at high sampling cone voltage permitted class‐specific multiresidue detection of the six sulfonamides with minimal losses in sensitivity. An analytical method is proposed for the detection, confirmation and quantification of sulfonamides and metabolites in milk with sensitivity equal to or greater than those obtained with less specific methods involving liquid chromatography with a UV detector. The relative simplicity of this technique and the availability of benchtop instrumentation suggests that routine screening and confirmation analyses of sulfonamide contaminants in milk is practicable.

Atmospheric-pressure chemical ionization

10.1002/rcm.1290071214

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Citations (28)

HRMS using a Q-Exactive series mass spectrometer for regulated quantitative bioanalysis: how, when, and why to implement

Bioanalysis (2016)

Robert M. Sturm Barry Jones Daniel Mulvana Steve Lowes

High-resolution MS (HRMS) has seen an uptake in use for discovery qual/quan workflows, however, its utilization in late discovery/development has been slow. Past reports comparing HRMS to triple quadrupole (QQQ) instrumentation to date have indicated that HRMS instruments are capable of producing data acceptable for regulated bioanalysis, however lack the sensitivity required for sub ng/ml LLOQ assays. Recent advances in HRMS instrumentation have closed the sensitivity gap with QQQ and have even provided improved selectivity and sensitivity over QQQ SRM assays. Herein, the authors will describe how, when, and why HRMS (specifically Q-Exactive series mass spectrometers) should be considered for implementation in regulated quantitative bioanalysis assays.

Bioanalysis

Instrumentation

10.4155/bio-2016-0079

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Citations (26)

Analysis of clenbuterol in human plasma using liquid chromatography/atmospheric‐pressure chemical‐ionization mass spectrometry

Rapid Communications in Mass Spectrometry (1993)

Daniel R. Doerge Steve Bajic Steve Lowes

Abstract Clenbuterol is a β‐agonist drug used illegally as a growth stimulant in meat‐producing animals and human athletes. The analysis of clenbuterol in spiked human plasma was performed using on‐line liquid chromatography/atmospheric‐pressure chemical‐ionization mass spectrometry (LC/APCI‐MS) using a conventional bore LC column (flow rate = 1.0 mL/min). At low sampling cone voltages, the mass spectrum was predominantly the [M + H] + ion but diagnostic fragment ions were formed upon incremental increases in sampling cone voltage. The detection limit (signal‐to‐noise ratio of 3) using selected‐ion monitoring of the [M + H] + ion was 0.1 ng on‐column (l0 ppb). This is a 50‐fold better sensitivity of detection than that previously reported for an on‐line thermospray LC/MS method. The extraction procedures were not optimized for maximum sensitivity and the lack of interferences suggests that much lower detection limits for clenbuterol in plasma are attainable.

Atmospheric-pressure chemical ionization

Clenbuterol

10.1002/rcm.1290070612

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Citations (26)

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Bioanalysis (2011)

Fabio Garofolo Mario L. Rocci Isabelle Dumont Suzanne Martinez Steve Lowes

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

Bioanalysis

Excellence

White paper

10.4155/bio.11.192

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Citations (95)

Recommendations on Bioanalytical Method Stability Implications of Co-Administered And Co-Formulated Drugs By Global Cro Council For Bioanalysis (Gcc)

Bioanalysis (2012)

Steve Lowes Mark Boterman Mira Doig Massimo Breda Jim Jersey

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.

Bioanalysis

10.4155/bio.12.192

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Citations (32)

Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Bioanalysis (2011)

Steve Lowes Jim Jersey Ronald E. Shoup Fabio Garofolo Natasha Savoie

"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"

Bioanalysis

Sample (material)

10.4155/bio.11.135

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Citations (86)