Featured Bioprocessing Editorial

  1. 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?

  2. 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.

  3. 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.

  4. 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.

  5. How To Ace Your Next CDMO Capabilities Audit
    6/18/2019
  6. 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.

  7. Off-Site Modular Fabrication Of Biopharma Facilities — What You Need To Know
    6/17/2019

    Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

  8. How To Develop Optimal Pharmaceutical Quality Control Strategies
    6/14/2019

    How can pharma product quality improve? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance.

  9. Are Biopharma's Strong Pipeline Innovations Reaching Patients?
    6/13/2019

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

  10. An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
    6/12/2019

    FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.