Industry Insights

  1. Is The FDA About To Reclassify Your Drug Product As A Device? 9/27/2021

    Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.

  2. CDMOs: The Good, The Great And The Exceptional (And How To Tell The Difference) 8/18/2020

    CDMOs can be critical to ensuring success for many early stage cell and gene therapy (CGT) companies with limited resources, but finding the right partner can often seem daunting in an increasingly crowded field. When evaluating CDMOs, it’s important to look beyond the basic attributes to the unique capabilities that will serve your organization best. This blog outlines the criteria for a successful CDMO partnership.

  3. Stages 2 And 3 QbD Validation Strategies For Nonsterile Solid Dosage Forms 4/11/2013

    In my previous communication in February, I provided an overview of stage 1 QbD validation strategies for process design for nonsterile solid dosage forms. In this article, I will continue to highlight strategies for validation prior to release of a commercial product (stages 2 and 3).

  4. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  5. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

  6. MAPK Signaling Pathway 4/7/2025

    Mitogen-activated protein kinase cascades regulate key cellular processes like proliferation, differentiation, and apoptosis. Explore how these pathways maintain cellular homeostasis and contribute to disease development.

  7. Why Use Agarose In Chromatography? 1/27/2023

    Learn why Agarose, a polysaccharide generally extracted from certain types of red seaweed, is widely considered the best material available for chromatographic MAb purification.

  8. Applying The Johari Window To Manage Biopharma Supply Chain Risk 2/14/2020

    The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to nitrosamine impurities have put the spotlight on sourcing strategies and the globalization of the pharma supply chain. The Johari Window model can help minimize the risk inherent in a complex supply chain.

  9. A Guide To Proactive Supplier Management In The Pharma/Biotech Industry 3/21/2024

    Proactively mitigate supply disruptions with strategic supplier selection and diversification, effective communication, risk management, quality assurance, and more.

  10. Survey Results Show What Could Finally Make Sustainability Stick 9/8/2023

    Results from BioPlan's "20th Annual Report of Biopharmaceutical Manufacturing and Production" show that lasting sustainability strategies should focus on profitability aspects. That's because, even more than a spirit of stewardship, financial advantages provide a powerful incentive to stick to the plan.