Articles by Tim Sandle

  1. Key Considerations In Selecting A Robotic Solution For Endotoxin Testing 7/6/2023

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

  2. 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.

  3. Not All Plate Counting Technologies Are The Same 5/18/2023

    While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.

  4. 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.

  5. 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.

  6. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

  7. ICH Issues Draft Guideline On Viral Safety Evaluation Of Biotech Products 12/8/2022

    Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. ICH's new draft guideline titled Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin is available for public comment through the FDA (ending Jan. 14, 2023) and through the EMA (ending Feb. 10, 2023).

  8. FDA Releases Guidance On Drug Products Containing Nanomaterials 11/18/2022

    In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

  9. 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.

  10. Your Guide To Producing ADCs That Meet cGMP Expectations 8/1/2022

    Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.