Contributing Editors

1. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

   The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

2. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

   When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

3. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

   In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

4. Sterility Assurance: The Fundamentals 10/8/2024

   Sterility assurance is a critical aspect of the production of drugs and medical devices. This article covers the fundamentals, including the key components of an effective sterility assurance program.

5. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

   Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

6. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

   More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

7. Team Topologies For Outsourced CMC Development 9/27/2024

   When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

8. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

   The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

9. Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain 9/25/2024

   Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

10. Araris Doubles Down With Dual-payload ADC 9/24/2024

    Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.