Featured Bioprocessing Editorial

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

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

  2. 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
    7/16/2019

    When a microbial data deviation occurs, microbiologists often struggle to determine the definitive root cause. Even the most experienced microbiologists find the lack of direct evidence and the fact that they are usually dealing with a past event to be major impediments to conducting a successful root cause analysis.

  3. 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. 

  4. 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.

  5. 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design
    7/9/2019

    Recent human factors research has revealed several special considerations that, if not handled properly, can cause serious problems related to delivery of these amazing new medications.

  6. 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.

  7. How Sherlock Holmes Helped Improve 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 RCAs. Keeping them in mind when conducting your analyses can greatly increase your chances of success in identifying that elusive definitive root cause.

  8. DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box
    6/27/2019

    The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?

  9. Environmental Isolates: What’s The Proper Use Of In-House Cultures?
    6/24/2019

    Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.

  10. Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing
    6/21/2019

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.