Expert Insights On Fill/Finish

51. Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing? 5/21/2024

    Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.

52. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

53. Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods 5/3/2024

    Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.

54. A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies 2/21/2024

    Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.

55. A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis 2/16/2024

    The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.

56. Picking The Best Virus Sample Prep Method In Process Development 1/26/2024

    Optimizing downstream operations in viral vaccine development starts with characterization. Learn strategies for picking the best sample prep method.

57. Developing A Viral Gene Therapy Manufacturing Process 1/23/2024

    There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.

58. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.

59. Is FDA's COVID Container Closure System Guidance Useful Post-Pandemic? 1/9/2024

    The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

60. Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield 1/2/2024

    It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status.