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AIT Bioscience Recognized with Awards at Recent WRIB

  WRIB (Workshop for Recent Issues in Bioanalysis) is an annual gathering of bioanalytical scientists from across the pharmaceutical industry spectrum. Attendees include big pharma and biopharmas, biotechs, CROs and multiple regulatory agencies working on both small and large molecule bioanalysis.   AIT Bioscience showcased its scientific prowess by garnering the Top LC-MS/MS Small Molecule … read the full article » »

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

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Strategy for Designing Electronic Lab Notebook Workflows Both Flexible Enough for R&D and Comprehensive Enough for Regulated Work

By: Brian D. Beato*; April L. Pisek; Jessica M. White   Electronic laboratory notebook (ELN) workflows are typically designed for either research or regulated use. Documentation requirements for regulated sample analysis are unnecessarily comprehensive and rigid for free-form research. Creating and validating separate templates targeted for different uses is inefficient. Presented here is a widely applicable, strategy for … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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Efficient Strategy for Generating Method-Specific Workflows in an Electronic Lab Notebook

By: Brian D. Beato; Jessica M. White; and April L. Pisek   One common concern among scientists regarding implementing an electronic laboratory notebook (ELN) is that method-specific workflows (or templates) may either lack sufficient detail to be useful, or require repeated validation exercises for each new method. However, with the widely applicable strategy for designing ELN workflows outlined … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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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 » »

Categories: Electronic Lab Notebooks (ELN), LC-MS/MS Methods

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Using Electronic Lab Notebook Functionality for Validating Electronic Lab Notebook Workflows

By: Brian D. Beato*; Timothy P. Grever; Laurel E. Branstrator   The use of electronic laboratory notebooks (ELNs) for regulated bioanalysis requires validation of numerous ELN workflows (templates). Presented here is a strategy for using common ELN functionality to validate workflows such that reviews are more efficient and comprehensive than for traditional software validation. The resulting electronic records … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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Accelerating Data Review in a Paperless Laboratory with ELN

By: Ron Shoup   The issues with paper:– Searching for information in paper systems– Printed methods and companion paper forms– Detecting disconnects between various papersystems (equipment calibration expiration vs. use in study)– Knowing when data is truly created in a paper system– Knowing whether results are built from secured and validated resources– Exhaustive QC checks to verify data … read the full article » »

Categories: Electronic Lab Notebooks (ELN), Quality Assurance and Electronic Laboratory Notebooks

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Qualification of a Robotic Liquid Handler to Prepare Bioanalytical Runs

By: Ron Shoup and Michael Pugh   Bioanalytical method validations require the preparation of both routine and specialized samples. However, the process is similar from one molecule to the next, and much of the work can be handled robotically if terms and procedures can be standardized.   To read more see the attached pdf.   … read the full article » »

Categories: LC-MS/MS Methods

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Auditing a Regulated Study Utilizing an Electronic Laboratory Notebook (ELN)

By: Abby K. Bousum and Laurel E. Branstrator   The steps for auditing always will be an exercise in puzzle-assembly –but now we have electronic tools (eTools) for assistance. Assembly of all the pieces that constitute a study occur within the laboratory, various electronic systems, and culminate within the ELN. The ELN serves as both a … read the full article » »

Categories: Quality Assurance and Electronic Laboratory Notebooks

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Going Paperless: Implementing an Electronic Laboratory Notebook in a Bioanalytical Laboratory

By Brian Beato; Laurel Branstrator; Barbara Carel; Brian Engel; Timothy Grever; April Pisek; Michael Pugh; Michael Schneider; Ronald Shoup; and Jessica White   The aim of any bioanalytical laboratory is to deliver quality data fast. Proper implementation of an electronic laboratory notebook (ELN) can play a major role in accomplishing these goals by both increasing laboratory … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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A Rapid LC-MS/MS Alternative to the Isotope Dilution GC-MS NIST Reference Measurement Procedure for Determining Glucose in Human Plasma

By: Brian Beato; Michael Pugh; and David Hulbert   Manufacture of glucose monitors requires a reference measurement procedure (RMP)• Current NIST RMP for glucose in human serum involves sample preparation requiring 2-3 days• An LC-MS/MS method requiring about 1 hour for sample preparation offers a potential alternative   To read more see the attached pdf.   … read the full article » »

Categories: LC-MS/MS Methods

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