Algorithme Pharma Inc.

Montreal, Canada

Algorithme Pharma Inc.

Montreal, Canada
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Roberts C.A.,Durham University | Bernard M.-C.,Algorithme Pharma Inc.
Tuberculosis | Year: 2015

This study considers the biosocial profile of children admitted to the Philipson Children's Sanatorium at Stannington, Morpeth, Northumberland, England (1936-1954). The objective was to understand the differential impact of TB on male and female admissions at Stannington, according to a number of variables. A total of 1987 medical files were analysed. More females than males were admitted, peaks of admission at age six and 13 were documented, and the majority of children derived from poor urban areas. Over 60% (1199, 63.5%) of children had pulmonary TB, and 12% (230) had bone or joint involvement. The implementation of chemotherapy (streptomycin) at Stannington (1946), the end of the 2nd World War (1945), and the founding of the National Health Service (1948) did not have any great effect on the biosocial profile of children admitted to the sanatorium and treated (age, sex, origin, type of TB suffered, and socioeconomic status). Reasons for these finding are discussed. © 2015 Elsevier Ltd. All rights reserved.

Ramagiri S.,AB Sciex | Garofolo F.,Algorithme Pharma Inc.
Bioanalysis | Year: 2012

Background: Recent developments in LC-MS have turned it into a viable and valid alternative to ligand-binding assays. Large molecule bioanalysis by LC-MS is generally performed by tryptic digestion, purification and detection of one or more small signature peptides. High-resolution MS instruments offer quantification of intact small proteins or peptides and are able to increase the selectivity, while maintaining sensitivity. Results: Unlike multiple reaction monitoring assays, several factors affecting data processing were presented and the optimal parameters to consider during quantification method building were also demonstrated. MUC5AC-13 (MW 1709.8 Da), human hepcidin/LEAP-1 (MW 2797.4 Da), porcine calcitonin (MW 3604 Da) and chicken lysozyme (MW 14.3 kDa) were selected as model compounds and the possibility of intact peptide and small protein quantification, without tryptic digestion, was demonstrated. Conclusion: Selectivity and sensitivity were improved using different scan modes, such as TOF-MS and TOF-MS/MS. © 2012 Future Science Ltd.

Reanalysis of incurred samples showed that the bioanalytical method for the quantification of ramipril and ramiprilat was generating irreproducible results for ramiprilat. An additional peak interfering with ramiprilat was observed in the incurred samples but not in the calibrant and quality control samples. A similar interference was detected for ramipril, but it was chromatographically separated. Interferences were produced during sample preparation, which involves strong cation exchanger cartridges. The interfering products corresponded to the methylation of ramipril and ramiprilat glucuronide. Following this discovery, a reproducible method was developed and successfully validated for ramipril and ramiprilat. Additional stability tests were performed in the presence of glucuronide and diketopiperazine metabolites of ramipril and ramiprilat to demonstrate the method specificity.

Recently, incurred sample reanalysis (ISR) has become a requirement in bioanalysis. The general guidance recommends investigating ISR failure to evaluate the suitability of an analytical method. In the case of acceptable ISR evaluation, there were no precise recommendations for further testing when sporadic values were obtained. The ISR evaluation performed during a bioequivalence study for the anticonvulsant drug oxcarbazepine showed acceptable ISR results, but one particular chromatographic anomaly led to a thorough investigation. The finding of these tests showed that an oxcarbazepine phase II metabolite occasionally co-eluted with the drug and impacted oxcarbazepine's quantitation through in-source conversion. This paper demonstrates the necessity of rigorous interpretation of ISR results and close monitoring of all subject sample results.

Taillon M.-P.,Algorithme Pharma Inc. | Furtado M.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc.
Bioanalysis | Year: 2011

Marie-Pierre Taillon holds a Bachelor of Science in Biochemistry. She is a senior scientist in method development at Algorithme Pharma, a CRO located in Laval, Canada. She has been working in the bioanalysis industry for the past 11 years where she became an expert in method development, especially in the LC-MS/MS field. Her experiences have led her to conduct robust and effective method development of bioanalytical assays. Marie-Pierre has acquired over the years an expertise with the '-limus' compounds (e.g., tacrolimus, sirolimus and everolimus) and other complex molecules. The quantification of tacrolimus in human whole blood was developed by LC-MS/MS for a range of 50.0 to 50,000.0 pg/ml. Different challenges were faced during method development due to ion-suppression, lack of sensitivity and low recovery. The optimization of the extraction procedure played a crucial role as tacrolimus had to be isolated from red blood cells, to which it is strongly bound. Another particular challenge arose from the freeze-thaw stability where the extracted samples from fresh blood always showed a lower recovery. Finally, matrix effect was observed in some matrices over time, which resulted in a failed long-term stability in whole blood. In order to resolve the matrix effect issue, the sample procedure had to be improved. The final assay showed good recovery, low matrix effect, linearity, blood stability and good precision and accuracy. © 2011 Future Science Ltd.

Dumont I.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc.
Bioanalysis | Year: 2011

The 1st Conference in Asia-Pacific on Recent Issues in Bioanalysis was organized by the Calibration and Validation Group. This event, a 2-day full-immersion conference, was the first of this kind in the Asia-Pacific region, following four successful editions held in Montreal, Canada. This conference brought together scientists and experts from across Asia-Pacific and the rest of the world to discuss, review, share perspectives, provide potential solutions and agree upon consistent approaches on recent issues in bioanalysis. A total of 27 invited speakers from worldwide regulatory agencies, pharmaceutical companies and CROs provided interesting and pertinent oral presentations. All discussions were focused on high-quality, better compliance to regulations and scientific excellence. © 2011 Future Science Ltd.

The 19th International Reid Bioanalytical Forum was held in July 2011 in the UK. This open forum was an ideal meeting for extensive discussions on topics, such as global harmonization of bioanalytical guidance, in both formal and informal settings. Indeed, this meeting is well-known for its numerous networking opportunities during the 3-day conference and for an ethos of debate on practical solutions to problems encountered in bioanalytical science.

Mekhssian K.,Algorithme Pharma Inc. | Mess J.-N.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc.
Bioanalysis | Year: 2014

Background: Monoclonal antibodies are the fastest growing class of protein therapeutics. Ligand-binding assays have been the technique of choice for the quantification of these large proteins; however, LC-MS and more recently LC-HRMS have been gaining momentum as robust alternatives for the bioanalysis of antibodies in biological matrices. Results: Optimization of sample preparation and LC-HRMS analysis in MRMHR mode has allowed us to develop a highly specific dual-peptide targeted assay for the quantification of Rituximab, in human plasma. The linearity of the assay was established from 1.0 to 200 g/ml for both light and heavy chain surrogate peptides, with accuracy and precision within 15%. Conclusion: LC-HRMS can be an effective tool for the quantification of monoclonal antibodies in regulated bioanalysis. © 2014 Future Science Ltd.

Youhnovski N.,Algorithme Pharma Inc. | Bergeron A.,Algorithme Pharma Inc. | Furtado M.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc.
Rapid Communications in Mass Spectrometry | Year: 2011

Quantification of analytes by Dried Blood Spots (DBS) on different paper cards has been extensively reported in the past several years. However, some factors limit the robustness of the precision and accuracy of DBS such as: hematocrit level, blood viscosity, analyte nature, spotting technique and spotting conditions. As such, the paper material used for DBS must meet strict quality control criteria to produce reliable quantification of drugs: uniformity, no chemical leaching and no chromatographic effect. To overcome these variables, especially the hematocrit impact, a modification of the traditional DBS, named Pre-Cut Dried Blood Spot (PCDBS), is presented. In contrast to the classical DBS technique, the new PCDBS procedure demonstrates no variation in response, within ±3%, independently of the hematocrit level or of the type of card used. The impact of the hematocrit level on the analyte recovery is discussed for both DBS and PCDBS approaches. Moreover, for quantification of naproxen by liquid chromatography/electrospray ionization tandem mass spectrometry (LC/ESI-MS/MS), the PCDBS technique was demonstrated to be as precise (%CV ≤3.1%) and accurate (%nominal between 95.4 and 104.4%) as the classical DBS procedure. Copyright © 2011 John Wiley & Sons, Ltd.

Morin L.-P.,Algorithme Pharma Inc. | Mess J.-N.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc.
Bioanalysis | Year: 2013

Background: Bioanalysts are continuously looking for innovative ideas or instruments to increase the sensitivity and selectivity of their assays. Research for better mass spectrometers is becoming crucial with the emerging trend of large-molecule quantification. This study lists the different advantages of high-resolution MS (HRMS) over standard triple quadrupole instruments and proposes basic guidelines on how to use HRMS for large-molecule quantification in a regulated environment. Results: A direct comparison between HRMS and triple quadrupole instruments for the quantification of six different model peptides (desmopressin, calcitonin, enfuvirtide, exenatide, glucagon and somatostatin) was completed. The HRMS instrument, when used specifically for targeted quantification ('quant/quan), showed equivalent or better sensitivity for all compounds tested. Conclusion: This paper demonstrates that the use of a HRMS instrument in a regulated environment is a viable technique for quantification of large molecules. The latter was able to allow flexibility and selectivity to adapt the specificity of each assay with sensitivity comparable to the triple quadrupole instrument. © 2013 Future Science Ltd.

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