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81. New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters 9/11/2023

    The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

82. From Chips To Genes: The New Era Of Animal Models Transforming Drug Testing And Research 8/16/2023

    The U.S. is at the forefront of the AI-based research trend surge to elevate the understanding of human physiology, testing potential therapies, and identifying disease mechanisms. Let's examine the five most promising innovative advancements in animal models, as well as key considerations for those working in the field.

83. CGMP Requirements For Automated Facility Monitoring Systems 8/15/2023

    To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

84. Mechanistic Modeling To Optimize rAAV Production For Gene Therapy 8/11/2023

    Current processes in recombinant adeno-associated virus (rAAV)-based gene therapy production are generally not readily scalable. A group of scientists and engineers at MIT collaborated with the team at UMass Chan Medical School to develop a mechanistic model for the intracellular phenomena occurring during baculovirus infection and rAAV virion production in insect cells. A free and user-friendly implementation of the model is available online, and you can use it to test a wide range of conditions and hypotheses.

85. How To Build Cell Culture Models With Purpose 8/9/2023

    Building a successful cell culture model has two key requirements — a clearly defined purpose from the outset and good data that support the purpose. This article discusses aspects to consider when characterizing complex cell cultures through modeling.

86. Agile Software Development In Bio/Pharma & Medical Devices, Part 3 7/25/2023

    Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.

87. 6 Emerging Trends In Using Stem Cell Assays 7/24/2023

    Stem cell assays allow scientists to assess the self-renewal capacity, proliferation rate, differentiation potential, and other characteristics of stem cells. By understanding how stem cells respond to different conditions, scientists can optimize protocols for therapeutic use. Let's look at six emerging trends in using stem cell assays.

88. 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.

89. Biocompatibility Testing Tips To Speed Your Medical Device To Market 7/12/2023

    Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.

90. Agile Software Development In Bio/Pharma & Medical Devices, Part 2 7/11/2023

    Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.