Guest Columns

  1. Using Preliminary Hazard Analysis To Determine Equipment And Instrument Requalification Frequency

    Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history to confirm consistent production results meeting the predetermined acceptance criteria.

  2. How To (Better) Identify And Analyze Manufacturing Trends In Your GxP Organization

    This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)

  3. Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies

    The FDA has been issuing guidance documents addressing gene therapy development issues for approximately 20 years — a remarkable dedication of resources to an area that did not have a licensed product until 2017. Of the six gene therapy-related draft guidances the agency issued last month, two represent the first of the “suite of disease-specific guidance documents on the development of specific gene therapy products” Commissioner Scott Gottlieb promised in Dec. 2017. 

  4. Manual Aseptic Processing: The Last Resort Or The Best Approach?

    When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.

  5. 4 Future Scenarios For Cell And Gene Therapy Adoption

    Cell and gene therapies are finally becoming a reality, with hundreds of clinical trials underway and some major therapeutic breakthroughs already reaching the market. In the past year alone, the FDA approved its first gene therapy, Spark’s Luxturna for the treatment of a rare form of vision loss, as well as the first two CAR T-cell therapies, Novartis’s Kymriah and Gilead’s Yescarta, for certain forms of blood cancer. While this certainly marks the beginning of an exciting period in the development of cell and gene therapies — the culmination of decades of development — the future impact of cell and gene therapies is uncertain.

  6. Education Vs. Experience: Which Is More Important In GMP Operations?

    When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?

  7. Justification & Qualification Of Visual Inspection For Cleaning Validation In A Low-Risk, Multiproduct Facility

    Proposals for the use of visual inspection (VI) as an analytical method for cleaning validation have been rising for several years now.1 This article discusses regulatory views on the use of VI as a sole criterion in cleaning validation, presents a case study on how inspectors can be qualified for VI, recommends the use of statistical techniques, and suggests how VI could be implemented as part of a control strategy in a cleaning validation program based on the level of risk.

  8. Summarizing FDA’s New Guidance On Gene Therapy For Hemophilia

    The FDA recently issued six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the final article in a six-part series summarizing each of the draft guidance documents. It will discuss the guidance Human Gene Therapy for Hemophilia.

  9. FDA’s New Guidance On Gene Therapy For Retinal Disorders — A Primer

    The FDA recently issued six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the fifth article in a six-part series summarizing each of the draft guidance documents. It will discuss the draft guidance Human Gene Therapy for Retinal Disorders.

  10. What Pharmacists Need From Biosimilar Developers

    Pharmacists can play an important role in the biosimilar ecosystem, educating prescribers about the benefits of biosimilars and serving as final gatekeepers to their adoption. For a behind-the-lines perspective on pharmacists’ current views regarding biosimilars — and what developers should be doing to engage them as allies in driving biosimilar uptake — we reached out to Steven Lucio of Vizient Inc., a group purchasing organization (GPO) with over $50 billion in total member spend. As associate VP of Pharmacy Services, Lucio provides education to Vizient’s member organizations on topics such as benchmarking pharmacy costs for critical drug classes, evaluating the expense of high-cost biologics, and preparing for implementation of biosimilar medications.