Featured Pharma Online Editorial

1. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

2. We Must Rethink The Solvents We Use For Peptide Synthesis 4/21/2025

   While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

3. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

4. The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization 3/25/2025

   For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

5. The Technologies Propelling GLP-1 Analogues 3/18/2025

   This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.

6. Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials 3/4/2025

   Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.

7. Comparison Of WFI Production Methods: Multi-Effect Distillation Vs. Vapor Compression 2/18/2025

   The two most common hot water for injection (WFI) generation methods are multi-effect distillation (MED) and vapor compression (VC). There are significant differences in terms of operational principles and energy efficiency.

8. Growth And Trends In Topical Drug Contract Manufacturing 2/14/2025

   Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.

9. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

10. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.