Guest Columns

  1. Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.

  2. An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

  3. Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  4. Building A Productive Relationship With FDA: Beyond The Science

    Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

  5. What Would Steve Jobs Tell The Pharma/Biotech Industry?

    Whether you’re a fan of Steve Jobs and his products or not, two things are undeniable: He was very successful and very different. Now you can relax; this short article will not provide a blow-by-blow account of the man and his methods. “What would Steve Jobs tell the pharma/biotech industry?” is just a metaphor to encourage our industry to radically change — not by reinventing the wheel, but by copying the success of others.

  6. Engaging A Life Science Consultant: Common Pitfalls & Best Practices

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

  7. 9 Steps To Train Your Personnel To Think Beyond The SOP

    We need to teach people how to think again. Then, we need to encourage them to think on a day-to-day basis so that they’re comfortable with it when a problem arises that requires out-of-the-box, beyond-the-SOP thinking. 

  8. An Introduction To qFMEA – A Tool For QMS Risk Management

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. This article is an expansion on the idea presented by John Vanhouwe, QA manager at IAC Group, in his article Risk Based Thinking: Making Use of a New FMEA Tool Called O-FMEA.

  9. Handling & Processing Of Potent Compounds: A Holistic Approach

    The topic of potent compounds may seem obscure; however, it touches virtually every aspect of the biopharmaceutical business, from selection pressure in media to antibody-drug conjugates (ADCs). Every chemical and biological compound we work with has an MSDS (material safety data sheet) and an OEL (occupational exposure limit), which dictate how we must handle the compound and bring to the forefront issues of personnel safety and environmental impact that we must address in our manufacturing plants. When designing a process involving any potent compound, there are three aspects we must address directly: facilities, processing equipment, and people.

  10. Surveying The Current Legal Landscape For Biosimilars

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.