Biomanufacturing Featured Articles

  1. Empowering Biopharma With Single-Use Cryopreservation Solutions 10/31/2023

    Explore four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications.

  2. 1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next 10/30/2023

    The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.

  3. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  4. Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management 10/19/2023

    What are the practical implications of the latest Annex 1 update, specifically for cold chain management?

  5. Challenges In Viral Vector Production & Innovative Solutions 10/18/2023

    Single-use technology is playing a large role in increasing flexibility and reducing contamination risks for the biopharmaceutical industry. Take a deeper look into all of the advantages and challenges.

  6. The 6 Must Haves Of Bioprocess Software 10/11/2023

    Utilizing modern technologies to create bioprocess software and discover scalable solutions that meet your existing and future data needs for bioprocessing.

  7. Sustainable Freezing In Biopharma 9/11/2023

    How does this pivot to natural gas-driven refrigeration platforms in the pharmaceutical manufacturing arena pose challenges and is sustainable cryopreservation possible?

  8. Cryopreservation In Stem Cell Therapy 9/5/2023

    The cryopreservation process maintains the structural integrity of living cells, but what other information is crucial for manufacturers when considering cryopreservation and its impact on cell-based therapies?

  9. What We Can Learn From The Cancer Drug Shortages 8/30/2023

    The dramatic shortage of essential cancer drugs, including cisplatin and carboplatin, has exposed gaps in the pharmaceutical supply chain. Here's what we can learn from it about building resilience and how alternatives like monoclonal antibodies can help reduce reliance on cornerstone therapies.

  10. Use Light-Scattering To Predict How Biologics Will Behave In The Clinic 8/24/2023

    Review what light scattering techniques tell you, how to set them up, and how they’re used for developability assessment.