Expert Insights On Downstream Bioprocessing

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. NK Cell Therapies: How Artiva Biotherapeutics Leverages Its "Manufacturing First" Approach 4/24/2024

    We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.

  6. Improving Governance And Compliance With Knowledge Management 4/23/2024

    Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.

  7. Unpacking The Importance Of Lipid Nanoparticle Production Platforms 4/15/2024

    Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.

  8. How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing 3/28/2024

    Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.

  9. Considerations For Robust Implementation Of The Multi-Attribute Method 3/19/2024

    USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.

  10. Getting To Know MAM, The New Quality Control Strategy On the Block 3/11/2024

    When characterizing PQAs, the multi-attribute method offers a one-stop shop for analysis. This article explores technical considerations for this emerging strategy.