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Tag Archives for bioanalysis

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.   Ashley Brant and Dr. Neal Simmons represented AIT Bioscience (AITB) discussing LC-MS/MS assays, … read the full article » »

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

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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 » »

Categories: LC-MS/MS Methods, Screening Assay, Special Topics

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Involved in Ocular Therapeutics? Thoughts on a successful PK program

As our population ages there comes an increased demand for therapies to treat age related ocular diseases such as Age-related Macular Degeneration (AMD), glaucoma, diabetic retinopathy and dry-eye.  In fact, the global market for ocular drugs is expected to reach $21.6 billion by 2018 according to a Transparency Market Research article.   Successful bioanalysis in … read the full article » »

Categories: Special Topics

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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 » »

Categories: LC-MS/MS Methods, Proteins and LC-MS/MS

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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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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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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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How to Implement a Validated Method

By: Ron Shoup   Familiarize yourself with the method: –Review the method–Review the method validation report–Examine the stability claims–Build the “assets” required to run the method–Establish competency   Reference standards–Identity–Purity–Storage condition–ExpirationSampling–Compare in-life protocol to method’s requirements–Matrix, species, anticoagulant–Preservatives, inhibitors, blocking agents–Timing, temperature–Containers   To read more see the attached pdf.    How To Implement a Validated … read the full article » »

Categories: LC-MS/MS Methods

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My Hamilton Can Beat Your Analyst

By: Ron Shoup   Goals:– Reduce human labor and error• Automated pipetting• Use the right materials- barcoded assets- no exceptions– Reduce tracking of materials for stability• Make fresh- collect in-study stability data every run– Enable fast changeovers between methods• If you can standardize on “method structure”   To read more see the attached pdf.   … read the full article » »

Categories: LC-MS/MS Methods

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