Our Expert Network

51. CRISPR-Cas Genome Editing For Rejuvenation Of Aging Stem Cells 7/1/2024

    As stem cells age, their regenerative capacity declines due to accumulated genetic and epigenetic changes. Using CRISPR-Cas, scientists can directly edit these changes or modulate aging-related pathways.

52. What Does FDA's Draft Platform Guidance Mean For CGT Companies? 6/17/2024

    Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.

53. Do You Know Your QMM? Moderna Might Some Day 6/17/2024

    Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.

54. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

55. Managing Change In Vaccine Production With All Stakeholders 6/12/2024

    Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.

56. 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.

57. 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.

58. 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. 

59. 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.

60. 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.