ARTICLES BY TIM SANDLE

  • ChatGPT-4: Practical Applications For The Biopharma Laboratory
    7/3/2024

    AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?

  • AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
    4/8/2024

    The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

  • Using Automation For Antimicrobial Screening
    10/5/2023

    A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.

  • FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity
    7/18/2023

    The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

  • FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors
    5/23/2023

    An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

  • 5 Characteristics Of The Automated Microbiology Lab Of The Future
    4/24/2023

    The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

  • Tackling Safety Issues Of Adjuvanted Vaccines
    3/8/2023

    An adjuvant is a substance added to some vaccines to enhance the immune response and/or to reduce the number of doses required to achieve a protective effect. This article discusses the emerging use of adjuvants and assessing safety issues.

  • How Can Nanomedicine Innovations Combat Cancer?
    10/24/2022

    For the past two decades, nanotechnology has promised a revolution in medicine, especially in creating new ways to deliver medicines to treat cancer. This article shares an overview of nanomedicine and some of the key innovations within the field during the past year.

  • The Current Landscape Of mRNA Vaccines In Clinical Research
    3/17/2022

    With the Pfizer-BioNTech and Moderna products, mRNA vaccines made global headlines in 2021 in the fight against COVID-19. As we recognize National Immunization Awareness Month, this article shares how mRNA vaccines currently in clinical research and clinical trials may be soon used to fight HIV-1, herpes, cancer, and more.

  • 10 Critical Validation Parameters For Microbiological Experiments
    7/26/2021

    In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.

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Tim Sandle

Tim Sandle, Ph.D., is a pharmaceutical professional with wide experience in microbiology and quality assurance. He is the author of over 30 books relating to pharmaceuticals, healthcare, and life sciences, as well as over 170 peer-reviewed papers and some 500 technical articles. Sandle has presented at over 200 events and he currently works at Bio Products Laboratory Ltd. (BPL), and he is a visiting professor at the University of Manchester and University College London, as well as a consultant to the pharmaceutical industry. Visit his microbiology website at www.pharmamicroresources.com.