Blogs -AIT Bioscience

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 » »

Categories: Biomarkers, LC-MS/MS Methods, Ligand Binding Assays (LBA), Partnerships



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Continuing to Expand our Capacity at AIT Bioscience

2016 is turning into a great year for AIT Bioscience (AITB) and our sponsors. Funding in the biotech market is up sharply over previous years and sponsors are moving programs forward at a rapid pace. From early preclinical non-GLP through clinical phase of development, our clients are pushing for more capacity to shorten program lead-times. … read the full article » »

Categories: Uncategorized



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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 » »

Categories: LC-MS/MS Methods, 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 » »

Categories: LC-MS/MS Methods, 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 » »

Categories: LC-MS/MS Methods



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Is Your ELN Lab Optimized for Faster, Better Data?

Bioanalytical contract research organizations (CROs) have been adopting electronic lab notebooks (ELNs) for several years now, but few ELN labs deploy a validated, fully-integrated platform. As we recently wrote for Contract Pharma, the jump from an electronic sticker book to a truly paperless workflow can revolutionize a lab’s efficiency and prevent errors before they happen. … read the full article » »

Categories: Electronic Lab Notebooks (ELN)



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Instability of a Stable Drug

Author: Brian Beato, LC-MS/MS Laboratory Director   Brian Engel, a senior scientist at AIT Bioscience, was modifying a bioanalytical LC-MS/MS method for fentanyl, a well-characterized compound with which he has had a lot of experience.  This time, however, he stumbled upon a surprising lack of stability for fentanyl in human plasma that had never been … read the full article » »

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Critical Reagents Consideration for Ligand Binding Assays

Ligand binding assays (LBAs) are bioanalytical procedures commonly used to support biotherapeutic development. These assays are used for the characterization of pharmacokinetics, biomarkers, and/or immunogenicity.  LBAs, unlike classic LC-MS/MS, utilize the interactions of a biotherapeutic and proteins used as critical reagents to detect the analyte of interest.  Therefore, special considerations must be made in the … read the full article » »

Categories: Biomarkers, ELISA, Immunoassay, Ligand Binding Assays (LBA)



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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 » »

Categories: LC-MS/MS Methods



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Biosimilar Drug Development-Establishing PK and Immunogenicity Equivalence

Biosimilar Drug Development07:29:59 How We (and the FDA) Establish PK and Immunogenicity Bioequivalence One key question AIT Bioscience regularly receives is: “Is it better to use two separate PK or immunogenicity assays to analyze the reference product and the biosimilar, or should we use a one-assay approach?” Our advice has always been in the interest … read the full article » »

Categories: ELISA, Immunoassay, Ligand Binding Assays (LBA), Uncategorized

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