Guest Columns

  1. How Pharma Manufacturers Must Prepare For EU MDR And IVDR
    10/16/2019

    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.

  2. Intro To Prefilled Syringe Selection: Staked-In Needles
    10/15/2019

    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. 

  3. The Need For Enhanced Control Strategies In Biopharma Production
    10/15/2019

    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. 

  4. ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    10/11/2019

    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.

  5. A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility
    10/9/2019

    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.

  6. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
    10/8/2019

    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.

  7. FDA FY2018 Drug Inspection Observations And Trends
    10/7/2019

    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.

  8. Comparing U.S. & EU Guidances On Combination Product Approval ProcessES
    10/4/2019

    New EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts to regulate combination products. In Part 2 of this series, we cover the EU guideline and show how two diverge.

  9. Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
    10/2/2019

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  10. Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
    10/1/2019

    A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.