Featured Bioprocessing Editorial

  1. 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.

  2. 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.

  3. 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
    7/17/2019

    Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.

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

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

  5. Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods
    7/11/2019

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

  6. IPR For Biosimilars: Examining The Benefits And Drawbacks
    7/11/2019

    Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

  7. Equipment Change Control For GMP Production Facilities — Proving It All Works
    7/10/2019

    The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) pre-installation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

  8. 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
    7/9/2019

    Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. 

  9. Bio/Pharma Maintenance 4.0: How To Get Started
    7/5/2019

    Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.

  10. How Sherlock Holmes Improved My Microbiological Root Cause Analyses
    7/3/2019

    This two-part article contains a collection of some of the most famous quotes attributed to Holmes that can be applied to microbial root cause analyses (RCAs). Keeping them in mind when conducting your analyses can greatly increase your chances of success in identifying that elusive definitive root cause.