Colorado Springs, CO, United States
Colorado Springs, CO, United States

Time filter

Source Type

Lowes S.,Quintiles | Boterman M.,ABL | Doig M.,ABS Laboratories | Breda M.,Accelera | And 88 more authors.
Bioanalysis | Year: 2012

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. © 2012 Future Science Ltd.


Lowes S.,Quintiles | Lelacheur R.,Agilux Laboratories | Shoup R.,AIT Bioscience | Garofolo F.,Algorithme Pharma Inc. | And 42 more authors.
Bioanalysis | Year: 2014

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application. © 2014 Future Science Ltd.


Hayes R.,MPI Research | LeLacheur R.,Agilux Laboratories | Dumont I.,Algorithme Pharma Inc. | Couerbe P.,Atlanbio | And 59 more authors.
Bioanalysis | Year: 2016

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report. © 2016 Future Science Ltd.


Nicholson R.,PPD Inc | Lowes S.,Quintiles | Caturla M.C.,Anapharm Europe | Safavi A.,BioAgilytix Labs | And 42 more authors.
Bioanalysis | Year: 2012

The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis. The attendance consisted of 45 bioanalytical CRO senior-level representatives on behalf of 37 CRO companies/sites from six countries. In addition to following up on the issue of co-administered drugs stability and on recommendations regarding the European Medicines Agency guideline, this GCC Closed Forum discussed topics of current interest in the bioanalytical field with focus on ligand-binding assays, such as lot changes for critical reagents, positive controls and reference standards, specificity for endogenous compounds, qualification and validation of biomarker assays, approach for biosimilars and criteria for LC-MS assays of small versus large molecules. © 2012 Future Science Ltd.


Lowes S.,Advion BioServices Inc. | Jersey J.,Agilux Laboratories | Shoup R.,AIT Bioscience | Garofolo F.,Algorithme Pharma Inc. | And 40 more authors.
Bioanalysis | Year: 2011

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. © 2011 Future Science Ltd.


The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.


News Article | October 29, 2016
Site: www.prweb.com

Pyxant Labs Inc., a privately held bioanalytical laboratory, today announced that it has expanded its bioanalytical support capabilities for discovery PK studies. This expansion adds equipment, IT systems, facility improvements, and, most important, personnel with best-in-the-industry laboratory expertise. These resources ensure that we provide 2-day bioanalytical phase turnaround and the highest quality in the industry. The Pyxant Labs Contract Research Organization provides GLP and non-GLP bioanalytical and CLIA biomarkers support for pharmaceutical and biotech companies’ drug development programs. “We decided to expand our discovery PK services because of the need for this service in the industry. Offering a quick turnaround service, combined with the clear scientific understanding of what our clients require to make intelligent decisions on the progression of their development candidates is essential to today’s drug development activities” said Randall Guthrie, Vice President. “The experience Pyxant Labs has gained in the past 16 years serving the highly stringent pharmaceutical industry has created a clear cut understanding of the necessary attributes that our clients are searching for to support their early drug development continuum” said Jean Pineault, President and COO. About Pyxant Labs Inc. – Pyxant Labs is a bioanalytical laboratory offering two distinct laboratory services: Its GLP CRO unit supports drug development for pharmaceutical and biotech companies and its CLIA CLS division assays patient specimens, including urine, oral fluids and blood, for prescribing physicians, clinics, and hospitals, for medication management and clinical diagnostics. Founded in 2000, Pyxant Labs uses state-of-the art mass spectrometry to assay high value samples for regulated industries. Pyxant Labs practices within areas that draw upon the Company’s key strengths: Industry-leading scientific expertise, stringent technical-regulatory compliance, fast turnaround, and exceptional customer service. Its greater mission is to improve patient outcomes by offering the most reliable laboratory results, fast. For more information, contact Kathy Bouard at 719-593-1165 or kbouard(at)pyxant(dot)com http://www.pyxant.com


Settlage S.B.,Critical Path Services | Eble J.E.,Critical Path Services | Bhanushali J.K.,AMAR Immunodiagnostics | Cheever M.L.,Bayer | And 7 more authors.
Food Analytical Methods | Year: 2016

Genetically modified organisms (GMOs) express one or more exogenous genes inserted through genetic engineering resulting in the production of novel protein(s). Agencies responsible for deregulating GMOs require that levels of the newly expressed protein(s) be characterized. Ideally, the quantitation methods used will be validated according to Good Laboratory Practices (GLPs) that are accepted by these global regulatory agencies. Targeted protein quantitation may be performed using enzyme-linked immunosorbent assays (ELISAs) with commercial kits or specially produced and validated antibodies. Proteins may also be quantitated by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). Although some scientific guidance exists for validation of ELISA, the need remains for a harmonized set of protocols for protein quantitation in testing of GMOs, particularly for LC-MS/MS. We surveyed various industry experts to determine current practices for assay linearity, accuracy, and precision; assay specificity; detection limits; and methods to assess analyte stability for both ELISA and LC-MS/MS. We compared the survey results with assay criteria suggested in the literature and governmental guidance documents. © 2016 Springer Science+Business Media New York

Loading Pyxant Labs collaborators
Loading Pyxant Labs collaborators