Guest Columns

  1. Is Continuous Manufacturing A Good Fit For Generic Drug Products?
    7/25/2019

    Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.

  2. 3 Surefire Approaches To SOP Harmonization
    7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  3. How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy
    7/23/2019

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.

  4. Next Steps For Serialization In The Pharma Supply Chain
    7/22/2019

    The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.

  5. Will We Have Harmonized Standards By The MDR’s Date Of Application?
    7/22/2019

    The EU Commission has requested that EU Standardization Organizations draft revisions to their existing standards, adapt some international standards, and issue new standards in support of the MDR and IVDR before May 26, 2020. Which standards could meet the deadline, and where are there likely to be issues?  

  6. 4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them
    7/19/2019

    A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.

  7. Improving Study Efficiencies With Protocol Templates For Nonclinical Studies
    7/18/2019

    Clinical research organizations (CROs) are often required to adhere to a variety of sponsor-specific protocol and/or reporting templates, often presenting the same information in various places or in different ways, depending on sponsor-specific requests. Maintaining multiple templates requires a significant amount of time and resources.

  8. Private Equity Accelerating Consolidation In The CDMO Market
    7/16/2019

    The CDMO industry has benefitted from big pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The sector has grown at a consistent 7 percent compound annual growth rate (CAGR) for the better part of a decade, outpacing that of the greater pharmaceutical industry itself. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.

  9. Applications For Single-Use Systems In Biosimilar Development
    7/16/2019

    Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

  10. Medtech Consolidation And The Outsourcing Competitive Landscape
    7/15/2019

    While consolidation may have somewhat predictable effects in most medtech markets, this trend has a distinct impact on competitors in the outsourced devices market.