Contributing Editors

  1. The Business Case For Pharmaceutical Continuous Manufacturing 6/2/2023

    Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.

  2. Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing 5/24/2023

    During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.

  3. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  4. Let’s Explore Packaging For Aseptic Manufacturing 5/19/2023

    When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.

  5. Optimizing Digitalization To Accelerate Your R&D 5/19/2023

    Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.

  6. Not All Plate Counting Technologies Are The Same 5/18/2023

    While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.

  7. Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases 5/17/2023

    The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.

  8. FDA’s Digital Health Technologies Framework Addresses Important Challenges 5/16/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  9. A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms 5/16/2023

    The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.

  10. 5 Hot-Button Issues In Parenteral Packaging 5/16/2023

    Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.