Featured Pharma Online Editorial

  1. 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.

  2. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

  3. Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead 5/19/2025

    Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.

  4. A Road Map For PAT Monitoring And Control 5/8/2025

    Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.