Bioanalysis Zone

Bioanalysis Zone at the 8th Workshop on Recent Issues in Bioanalysis

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The Bioanalysis Zone team had a very productive trip to the 8th Workshop on Recent Issues in Bioanalysis (WRIB; CA, USA) , on the 10-14 March 2014. We were delighted to meet so many of you there! As usual the event had a host of excellent talks by key experts in all aspects of bioanalysis, with sessions on small molecules, large molecules, LC-MS, LBA and immunogenicity, plus a full program of training workshops and discussions for the forthcoming White Paper.

We were particularly proud to support the first WRIB Poster Award, with Zone Editor Charlotte Barker taking the stage alongside meeting organizer Fabio Garofolo, to present the awards to Selena Larkin (SISCAP Assay Technologies) and Stephanie Cape (Covance). The winners’ profiles and posters will be included in a special feature here on Bioanalysis Zone shortly. Some of the other presenters have also agreed to share their posters with us – you can see a full list below.

The event was held atop the Hollywood hills, and we got into the spirit by filming a collection of (bioanalysis)star-studded interviews, with the help of our excellent cameraman Mike (Kolkey Productions). Look out for the videos, coming soon to Bioanalysis Zone!

Bioanalysis will again publish the annual Bioanalysis white paper from the meeting. Expected to go live in August, the white paper is always highly anticipated – we will keep you posted as we near publication.
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Poster: Evaluation of matrix effect when matrix factor is not enough for LC-MS/MS bioanalytical method
Jason Bilodeau, Nadine Lafontaine, Pierre-Yves Caron, François Viel, Sylvain Lachance, Nadine Boudreau and Ann Levesque (inVentiv Heath Clinical)

Summary: Matrix effect must be evaluated for LC-MS/MS bioanalytical methods. EMA suggests to evaluate the matrix effect with the matrix factor procedure. Herein, two procedures are described using pyridoxine-5-phosphate (Pn5P) showing that matrix effect cannot be associated exclusively to ionic suppression or enhancement.
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Poster: Robust and ultrasensitive determination of hormones and steroids by LC-MS/MS
Sylvain Lachance, Danielle Lachance, Nadine Boudreau, Sofi Gagnon-Carignan and Ann Lévesque(inVentiv Health Clinical)

Summary: The therapeutic use of hormones and steroids is widely known among the pharmaceutical community. They are used for many indications. Contraceptive hormones and hormonal therapy are among the most common use of these compounds. The goal of this work is to demonstrate that the LC-MS/MS determination of hormones and steroids can be reliable and robust.
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Poster: Interference from donor gender on long-term stability of etonogestrel in human plasma
Nicolas Jean, Marie-Claude Théberge, Sylvain Lachance, Nadine Boudreau and Ann Lévesque (inVentiv Health Clinical)

Summary: Etonogestrel is the active metabolite of the inactive prodrug desogestrel, a steroidal progestin used in hormonal contraceptives. A bioanalytical study was performed for the determination of etonogestrel in human plasma from a clinical study. To cover the life of the study samples, the long-term stability (LTS) in human plasma of etonogestrel needed to be extended from 114 to 174 days at -20°C. However, LTS evaluation of 139, 183 and 196 days failed with %bias above 15% at the low concentration level for the stability samples.
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Poster: How the origin of donors can influence the quantitation of a compound in plasma: case studies of matrix effect
Caroline Savard, Jason Bilodeau, Marie-Josée Marcoux, François Viel, Sylvain Lachance, Sofi Gagnon-Carignan, Nadine Boudreau and Ann Lévesque (inVentiv Health Clinical)

Summary: It is recommended in the guidelines for method validation that matrix effect from special population should be studied. “If samples from special populations(such as renally or hepatically impaired populations) are to be analysed it is also recommended to study matrix effects using matrix from such populations.” However, when studies are done in countries with different alimentary customs, should the matrix effect on that population be evaluated?
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Poster: Validated multi-site GLP-compliant analysis of solithromycin (SOLI) in monkey plasma
Gregory Reynolds, David Beyerlein, Bruce Babson – (MicroConstants) Prabhavathi Fernandes, Amanda Sheets – (Cempra Pharmaceuticals)

Summary: A highly sensitive method was developed and validated to allow monkey plasma samples, potentially containing Bacillus anthracis (B. anthracis) spores, to be sterilized and shipped from the collection sites to the bioanalytical laboratory for analysis of Solithromycin (SOLI), a novel fluoroketolide antibiotic, and two of its metabolites.

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