Featured Articles

1. Early Product Characterization De-Risks Biologics Development 6/12/2019

   The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

2. Using Next Generation Sequencing To Test Raw Materials 5/13/2025

   Explore the use of Next Generation Sequencing (NGS) to proactively screen raw materials in biopharmaceutical manufacturing, which aims to reduce viral contamination risks from animal-derived reagents.

3. Replacement Of Traditional Adventitious Virus Testing 5/13/2025

   Explore how molecular-based technologies, including PCR and Next Generation Sequencing, are transforming viral safety testing by offering broader, more effective alternatives to traditional animal-based methods like in vivo assays.

4. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

   Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

5. Little Patients, Big Challenges: Developing Pediatric Formulations 5/12/2025

   Explore the development of high-quality, child-friendly oral formulations, as well as learn about new testing requirements for impurities and innovative approaches to creating age-appropriate medications.

6. Strategies For The Development Of Safe And Effective Pediatric Formulations 5/12/2025

   Medicines for infants and children face unique formulation challenges. Learn about the key considerations, including developmental physiology, age specifics, palatability, ease of administration, and precise dosing.

7. Helpful Biosafety Testing Innovations Where And When You Need Them 4/24/2025

   Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

8. Process Analytical Technology In The ADC Bioconjugation Process 4/23/2025

   Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

9. De-Mystifying Regulatory Support During Viral Vector-Based Development 4/15/2025

   Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

10. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

    Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.