Guest Columns

  1. Good Fences Make Good Neighbors: How To Build Strong CDMO Contracts

    As Robert Frost tells us in his classic poem Mending Wall, “Good fences make good neighbors.” This concept makes an apt analogy for the contracting process. I have discovered, through much trial and error, that relationships between product companies and CDMOs that are based on clear, detailed, and comprehensive contracts — i.e., “fences” — have better outcomes than similar collaborations that rely on handshakes and personal commitments.

  2. 5 Tips For Orphan Drug Development In A Price-Sensitive Payer Environment

    The first installment in this two-part series examined rising costs associated with orphan drugs and two related case studies. This second part provides actionable suggestions for developers.

  3. Supreme Court’s Amgen v. Sandoz Decision: More Questions Than Answers?

    On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted.

  4. Chinese & Indian Expectations For GMP Biologics Exports — A Comparative Assessment

    In our studies we asked respondents to indicate their facility’s primary objectives for biologics production today and in 10 years. We found that in China, 70 percent of biopharma facilities today are primarily focused on production for domestic consumption.

  5. Quality By Design: Rethinking Data-Driven Risk Management & Knowledge Management

    Successful implementation of quality by design (QbD) can lead to significant revenue growth and margins from the shortened development cycle. However, key challenges to a company’s QbD adoption include lack of technology and internal and third parties’ misalignment.

  6. Developing A Science-, Risk-, & Statistics-Based Approach To Cleaning Process Development & Validation

    Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.

  7. Responding To Regulatory Inspection Observations: Do’s and Don’ts

    It’s Friday, it’s late, and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn’t go well — five major observations, all relating to your quality system. When your boss enters your office, you know it’s not to wish you a good weekend. 

  8. An Introduction Process Analytical Technology

    The routine use of PAT in an integrated manner to design, measure, and control critical process quality and performance attributes through timely and appropriate measurements remains largely unrealized across the pharmaceutical industry. 

  9. The Basics Of Cleanroom Design & Material Transfer For Microbial Control

    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.

  10. Using Risk-Based Thinking To Manage Suppliers

    This article will first present the definitions and requirements regarding risk pertaining to the control of suppliers and then introduce some tools to incorporate and integrate risk management techniques within the QMS specifically applied to supplier management/purchasing controls.