Our Expert Network

81. The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing 6/10/2024

    This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.

82. Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing 5/29/2024

    Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

83. Bioprocessing Technology: You Are The Standard 5/28/2024

    Single-use bioprocessing equipment engineer and expert Paul Priebe has some advice for you. Next time you catch yourself questioning an equipment standard (or the lack thereof), take a good look in the mirror. 

84. A Spy At Moderna 5/28/2024

    Jason Kerr of Moderna is a snoop, a spy, a watcher of all things. More officially, he’s tasked by his employer with monitoring for regulatory changes in the environment. “Some do call it regulatory surveillance,” he says, “Some just regulatory monitoring.” Whichever, you might need to hire a Kerr, too. Here's why.

85. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

86. 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.

87. How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing 5/15/2024

    QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.

88. Gene Therapy: Global Market Trends & Notable Developments 5/8/2024

    New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.

89. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

    The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

90. New Initiative Seeks To Back Up ICH's Harmonization Mission 5/3/2024

    An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.