BIO From The Editor and Guest Columns

  1. 5 Essential Factors For A Successful Biopharma Product Launch

    Rapid changes in the biopharma industry are making it increasingly difficult to launch new products successfully. Especially challenging are novel treatment modalities such as gene and cell therapy; increased use of biomarkers; rare diseases with patients that are hard to identify, diagnose, and access; and expanded requirements to demonstrate economic value. 

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

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  3. An Introduction To Sampling Plans

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

  4. Trends To Watch In China’s Biopharma Industry

    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. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

  5. Solving Pharma’s Public Opinion Crisis

    Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.

  6. How Pharma Manufacturers Must Prepare For EU MDR And IVDR

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU MDR and EU IVDR will effect their products. No medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  7. Intro To Prefilled Syringe Selection: 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. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  8. The Need For Enhanced Control Strategies In Biopharma Production

    Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater. 

  9. 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.

  10. 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. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.