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  1. ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction 1/2/2025

    This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

  2. How Laboratory Manuals Fail Sites And Sponsors 12/19/2024

    In part one of this series, FlexPoint Bio Founder and CEO Elena Sinclair describes the hazards of poorly designed (and followed) clinical trial lab manuals.

  3. Lab Manual Gaps: Sabotaging Data One Sample At A Time 12/19/2024

    In part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.

  4. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

  5. 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025 12/6/2024

    Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

  6. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

    The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

  7. Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies 11/25/2024

    The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.

  8. Should We Explore Suicidality In Animals During Preclinical Drug Development? 11/19/2024

    An adverse side effect for some drugs is suicidal ideation and behavior (SIB). Investigating SIB in animal studies represents the closest approximation to human SIB, yet the FDA Modernization Act 3.0 obligates us to reduce unnecessary animal testing. Let's examine this with data-driven research.

  9. Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies 10/29/2024

    In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

  10. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

    When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.