LC-MS/MS Methods Archives - AIT BioscienceAIT Bioscience


Category Archives for LC-MS/MS Methods

American Society of Mass Spectrometry in Indy

From June 4-8, the city of Indianapolis got the privilege of playing host to nearly 6500 scientists from around the world who gathered to discuss all aspects of using mass spectrometry in a wide variety of applications. Several of our scientists were able to attend talks, workshops, and short-courses on LC-MS for antibody drug conjugates, proteins, … read the full article » »

Other Categories: Ligand Binding Assays (LBA), News

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AIT Bioscience Attends Bio+Tech17 and AAPS NBC Conferences

AIT Biosciences recently attended the Bio+Tech17 Conference in Bethesda, Maryland from April 27-28, 2017 and the AAPS NBC Conference in San Diego, California from May 1-3, 2017. Below are summaries of both conferences:     Bio+Tech17 Conference   The conference is run by the MD Tech Council and seeks to bring together innovators from across the … read the full article » »

Other Categories: Ligand Binding Assays (LBA), Proteins and LC-MS/MS, Special Topics, Uncategorized

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Bioanalytical Considerations for your Dermal Pharmaceutical Programs

Bioanalytical Considerations for your Dermal Pharmaceutical Programs Does your drug require sustained release or suffer from first pass metabolism losses?   Have you considered transdermal delivery via cream gel or patch?   How does bioanalysis differ for oral or dermal delivery?   The dermis is the largest organ of the human body and provides a … read the full article » »

Other Categories: Screening Assay, Special Topics

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Antibody Drug Conjugate Analysis: How Partnering with a Bioanalytical CRO Can Ease Preclinical ADC Programs

By: Frank Spriggs, Ligand Binding Assay Group Leader, and Ashley Brant, Program Manager   The potential of antibody drug conjugates (ADCs) to provide targeted therapies for cancers and other devastating diseases have made them popular candidates for drug development programs. However, as we discussed recently in Drug Discovery and Development, the failure of several ADCs … read the full article » »

Other Categories: Biomarkers, Ligand Binding Assays (LBA), Partnerships



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Therapeutic Peptides – Toeing the Line of Small and Large Molecule Bioanalysis

By: Bo Kowalczyk, Vice President of Business Development The pharmaceutical industry is so abuzz with the potential for biologic therapeutics that we often forget about peptide therapy. Despite boasting desirable qualities – low toxicity, high specificity, and high potency – the adoption of peptides into treatments faces many hurdles (Table 1). Design strategies that improve … read the full article » »

Other Categories: Ligand Binding Assays (LBA)



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What Level of Bioanalytical Method Validation is Right for My Early Stage Drug Development Study?

By: Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager During late phase drug discovery, everyone follows well established FDA bioanalytical method validation guidelines. However, opinions vary widely about what validation is necessary for early- to mid-phase studies. We are often asked by our clients: “How robust do I need this assay to … read the full article » »

Other Categories: Ligand Binding Assays (LBA), Partnerships



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How to Select the Right CRO for ADC Development

By: Franklin Spriggs, Ligand Binding Assay Group Leader; Stephanie Mowery, Senior Scientist; and Bo Kowalcyk, Vice President of Business Development     Antibody drug conjugates (ADCs) marry large and small molecule therapeutics into a single compound. A comprehensive ADC development strategy thus requires a lab that possesses both large and small molecule analytical expertise.   … read the full article » »



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Is it Important to Determine Recovery for LC-MS/MS Bioanalytical Methods Requiring Derivatization?

Written by Dr. Abe Brubaker and Dr. Brian Beato   The scientific merits of determining recovery values for analytes and internal standards as part of LC-MS/MS bioanalytical method validations have been discussed over the years, and remain somewhat controversial. However, the current and even the more recently proposed updates to the Guidance for Industry still … read the full article » »



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Bioanalytical Method Development Strategy for Proteins

By: Michael Schneider   A bioanalytical method development strategy is presented for quantitative protein analysis by LC-MS/MS when no capture antibody is available for bioanalytical sample clean-up or enrichment. A robust quantitative method for protein therapeutics can be quickly developed and performed in less than a day by using the Perfinity Workstation for on-line sample … read the full article » »

Other Categories: Proteins and LC-MS/MS

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A Paper-Free Fully Regulated Bioanalytical Assay Validation of Fentanyl in Human Plasma

By: Brian J. Engel; Michael R. Pugh; Barbara J. Carel; and Ronald E. Shoup   A fully validated bioanalytical method for fentanyl in EDTA human plasma spanning 5.00 – 5000 pg/mL was generated in a completely paperless laboratory. The model presented illustrates the application and interaction of multiple electronic laboratory systems to execute and document a validation … read the full article » »

Other Categories: Electronic Lab Notebooks (ELN)

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