Liquid Dose Featured Articles

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. Responding To Fill-Finish And Automation Scale-Up Challenges 5/21/2025

   Behind every life-saving cell therapy is a complex manufacturing journey. Examine the critical role of automation in overcoming production challenges and ensuring quality.

4. 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.

5. 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.

6. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

   The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

7. 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.

8. 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.

9. Fluid Management Strategies For Scalable Biopharmaceutical Production 4/16/2025

   Effective fluid management systems are indispensable in therapeutic manufacturing. Discover how modular design, automation, and single-use systems enhance scalability and maintain product integrity.

10. Key Takeaways From PDA Ireland Microbiology Event On Innovation And Technology 4/14/2025

    Insights from a PDA Ireland event reveal how innovative technologies like VR and automation are transforming sterile manufacturing, improving efficiency and addressing contamination control strategies.