Guest Columns

1. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

   CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

2. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

   The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

3. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

4. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

5. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

   Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

6. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

   As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

7. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

8. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

   The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

9. How APBio Builds Multispecific Analytical Target Profiles 5/22/2025

   Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation.

10. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.