Blogs -AIT Bioscience

AIT Bioscience Featured in Contract Pharma

As sponsors transition their programs from preclinical animal Tox studies to human clinical trials, sponsors turn to AIT Bioscience (AITB) to help understand the potential issues that may arise with their bioanalytical PK assays. In Contract Pharma’s October issue, AITB tackles this topic to highlight where some unexpected challenges and expenses can arise (Robust Assay … read the full article » »

Categories: Uncategorized



Comments Off on AIT Bioscience Featured in Contract Pharma


AIT Bioscience Expands Our Breadth and Depth with New Hires

AIT Bioscience is expanding! As part of this growth we’ve added two new members to our team:     Qian Li began working for AITB as a Sr. Scientist II in our LC-MS/MS assay development and validation group. She is originally from China and received a master’s degree in organic chemistry there. She then received … read the full article » »

Categories: Uncategorized



Comments Off on AIT Bioscience Expands Our Breadth and Depth with New Hires


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

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 during phase II and III trials due to limited efficacy proves more complete bioanalysis … read the full article » »

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



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


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



Comments Off on Continuing to Expand our Capacity at AIT Bioscience


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)



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


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

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 be?” “At what point can I use this data to present to … read the full article » »

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



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


How to Select the Right CRO for ADC 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. Increasingly, biopharma is turning to bioanalytical CROs (Contract Research Organizations) to characterize these molecules. A major reason is that the expertise and specialized … read the full article » »

Categories: LC-MS/MS Methods



Comments Off on How to Select the Right CRO for ADC Development


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)



Comments Off on Is Your ELN Lab Optimized for Faster, Better Data?


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 » »

Categories: Uncategorized



Comments Off on Instability of a Stable Drug


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)



Comments Off on Critical Reagents Consideration for Ligand Binding Assays