Featured Bioprocessing Editorial

  1. Gene Therapy: Commercial Challenges And Strategic Choices

    Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

  2. The China Biosimilars Market: Rise Of A Potential Powerhouse

    Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?

  3. 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development

    It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets. 

  4. Military Tool For Vulnerability Assessment: The CARVER + Shock Technique

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

  5. Techniques For Risk-Based Validation Using ASTM E2500

    This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective

  6. To Err Is Human: Contextual Communication’s Impact On Data Integrity

    Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.

  7. How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  8. Training Production Operators In Aseptic Technique: Common Pitfalls And How To Avoid Them

    Retraining an operator involved in a microbiological excursion is almost always part of the corrective and preventative action (CAPA), yet repeat excursions and deviations due to improper aseptic technique still routinely occur. So, why do some operators still have difficulty executing the task after completing such intensive training programs?

  9. Demonstrating Value And Securing Patient Access For Cell And Gene Therapies

    Because the parameters for ex vivo cell and gene therapy manufacturing differ considerably from chemical drug production, life sciences companies are likely to encounter challenges along key stages of the product life cycle.

  10. Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations

    Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.