Featured Bioprocessing Editorial

  1. 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.

  2. 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.

  3. 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. 

  4. 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.

  5. 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.

  6. 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?

  7. 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.

  8. 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.

  9. Transforming Next-Gen Therapy Supply Chains Into Patient-Connected Value Chains
    6/20/2019

    Cell, gene, and other emerging therapies are distinctly different from traditional biopharma products. Every lot is for a named patient or small population of patients, and that lot drives direct uplift on the bottom line. Traditional supply chain management does not necessarily create patient value in emerging therapy value chains. Operations should be the backbone of a distribution model that delivers these products efficiently and effectively over the last few yards.

  10. AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies
    6/18/2019

    Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.