Guest Columns

  1. A Framework For Measuring Training ROI Using Quality Metrics
    12/13/2017

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

  2. An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
    12/11/2017

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  3. The FDA/EU Mutual Recognition Agreement — What You Need To Know
    12/7/2017

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  4. Bioprocessing Trends To Watch In 2018
    12/6/2017

    The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets.  And these innovative platforms are going to continue to need improved manufacturing technologies in the future.

  5. Best Practices For Data Integrity Oversight At Your Contract Manufacturer
    12/4/2017

    Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

  6. Process Analytical Technology: Benefits Of Spectroscopic Tool Use
    12/1/2017

    To increase familiarity with process analytical technology (PAT), this article provides examples that illustrate where traditional analytical tests could be supplemented, improved, or replaced with these new tools, such as identity testing, concentration verification, and concentration monitoring (in real time).

  7. Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance
    11/29/2017

    A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.

  8. 10 Simple Steps To Selecting The Right CMO
    11/28/2017

    While presenting a webinar on the CMO selection process not long ago, I had a moment of clarity. Even though I didn't include the following words in 36-point block letters on any slide, I suddenly discovered the essence of the lecture as I adlibbed this declarative statement:

  9. Tips For Success In the Indian Biosimilar Market
    11/28/2017

    Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. According to the Generics and Biosimilars Initiative (GaBI), the first “similar biologic” was approved and marketed in India in 2000 — some 15 years before the U.S. approved its first biosimilar. India also has a much more mature biosimilar manufacturing ecosystem and regulatory environment than most other parts of the world. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.

  10. 3 Keys To Scale-Up CAR T-Cell Therapy Manufacturing
    11/27/2017

    Kymriah and Yescarta have overcome the first hurdle to commercialization by receiving the FDA’s stamp of approval. Now, Gilead and Novartis must prove they can handle the supply chain complexities involved with manufacturing and distributing these personalized, time-sensitive therapies to wider patient populations.