Our Expert Network

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Forum Notebook: Quick Takes From USP's mRNA Virtual Summit 5/1/2024

    The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.

  7. Assessing pDNA Purity For Cell & Gene Therapies 5/1/2024

    Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.

  8. mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention 4/26/2024

    mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.

  9. Advancing PSC-Based Therapies: The Application Of Non-Integrating Engineering Strategies To Improve Directed Differentiation 4/25/2024

    This article explains why the incorporation of non-integrating, traceless engineering tools in PSC directed differentiation approaches could significantly help streamline the development of allogeneic cell therapies.

  10. A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers 4/19/2024

    Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.