Industry Insights

  1. Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing 5/19/2021

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

  2. 505(b)(1) Versus 505(b)(2): They Are Not The Same 8/27/2021

    The 505(b)(2) pathway can yield significant benefits in drug development cost and time. But what are the differences in 505(b)(1) versus 505(b)(2)? They are not the same.

  3. 4 Pitfalls To Avoid With RWE For Regulatory Submissions 4/19/2022

    Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

  4. Key Trends And Developments In Injectable Drug Formulation And Delivery

    As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.

  5. Imagine The Future: Enhanced Oligonucleotide Synthesis 3/4/2024

    Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.

  6. Intensifying Downstream Processing With Magnetic Separation 3/10/2025

    A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.

  7. Key Considerations When Choosing A Device For Dry Powder Nasal Delivery 10/21/2024

    Building on previous discussions, here we discuss the benefits of nasal delivery and the challenges of developing dry powder formulations by focusing on key devices that can be used for delivering dry powder nasal dosage forms.

  8. Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead 5/30/2023

    Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.

  9. Autoinjectors: A Revolutionary Leap In Drug Delivery 2/7/2024

    Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

  10. Advanced Isolator Tech Boosts Manufacturing Efficiency And Quality 7/30/2024

    Isolator technology can run continuously over several days, minimizing operator interaction and other opportunities to introduce contamination — ideal for high-volume, time-limited production runs.