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61. 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.

62. Preformulation Of Excipients In Biologics Development 9/28/2023

    Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

63. FDA Introduces Quality Management Maturity Program 9/26/2023

    The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

64. 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.

65. 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.

66. 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.

67. 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.

68. 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.

69. 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.

70. 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.