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Ready to Roll; an Efficient Screening Level Assay Process

Back in January we wrote about fit-for-purpose bioanalytical assay support and announced a new small molecule LC-MS/MS screening level assay service at AITB.  Well, we’ve put this process through its paces and have shown our ability to consistently get variability down below 35% and in many cases down below 20%.  For a go-no/go decision point … read the full article » »

Other Categories: News, Screening Assay

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

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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 » »



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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 » »



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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 » »



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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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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 » »

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

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