Guest Columns

  1. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time

    In the article “Do The Arguments For Pharmaceutical Price Increases Make Sense?”, we began to look comprehensively at the U.S. healthcare system from a cost perspective.  In it, we acknowledged and illustrated that there is no single reason behind the outpacing of inflation and GDP growth by healthcare spending and healthcare pricing.  We then focused on the pharmaceutical industry, advancing data-driven arguments for how the risk of developing and obtaining approval of pharmaceutical products neither supports nor excuses the pricing of drugs we have seen in the United States. 

  2. An Introduction To Sampling Plans

    Sampling plans are used extensively throughout organizations regulated by the FDA. Most organizations have a statistical procedure that specifies a certain acceptable quality level (AQL) based on risk. (If not, they should!) However, most individuals just follow the requirements of the procedure without fully comprehending how sampling plans actually work.

  3. Trends To Watch In China’s Biopharma Industry

    Fueled by the country’s large population and rapid urbanization, China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future.  According to our research, the country’s pharma segment is projected to reach $175 billion by 2022, with its biopharma sales on track to reach over $50 billion. 

  4. How Pharma Manufacturers Must Prepare For The New EU MDR And IVDR Environment

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) will effect their products. However, under the new regulations, no medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  5. An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes, discussing the important aspects of those devices. In this part, we will examine the various aspects of prefilled syringes with staked-in needles and their impacts. We will conclude with some general thoughts on vendor selection for successful partnership.

  6. The Need For Enhanced Control Strategies In Biopharma And Biosimilar Production

    For many years, the pharmaceutical industry  meant “small (usually synthetic) molecules” mixed with various non-active materials and put into capsules or, in the old days, rolled into pills or pressed into tablets. While synthesizing the APIs (active pharmaceutical ingredients), formulating the dosage forms, and analyzing the materials at every step of the life cycle was not always trivial, it was relatively straightforward.

  7. ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  8. A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  9. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  10. FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.