Industry Insights

  1. Top 5 Considerations For CAR-T Trials During A Macroeconomic Downturn 2/28/2023

    Opportunistic organizations can take advantage of economic downturns by improving operations through technology, training, and hiring and claiming vacated manufacturing slots.

  2. New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology 3/29/2023

    Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.

  3. The Regulatory Affairs Function Is Evolving. Are You Evolving With It? 10/10/2024

    The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

  4. Top 10 Inspection Findings From FDA, MHRA, Russia's Ministry Of Health 10/7/2020

    Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.

  5. Keeping The Momentum In Pandemic Preparedness 10/22/2024

    Learn about the partnership between the Prairie HUB and Cytiva to create RNA vaccines to target potential pandemic viruses with the aim of redefining global pandemic preparedness.

  6. Improving NDA Approval Odds For New Dosage Forms Of Approved Products 1/31/2023

    Learn why providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

  7. How Do You Design A Safe And Scalable Synthetic Route For Your Drug Substance? 6/8/2022

    By performing drug substance development process activities in parallel with synthetic route development, you can make informed decisions and ensure it is right on the first try.

  8. How CCIT Helps CDMOs Fulfill Their Commitment To Quality 10/3/2023

    A lack of knowledge of container closure integrity testing (CCIT) could put a CDMO at a disadvantage compared to competitors, so it is critical to have a thorough understanding of CCIT.

  9. Is Continuous Manufacturing A Good Fit For Generic Drug Products? 7/25/2019

    Continuous manufacturing (CM), though well recognized by regulators and technology providers as a means to improve product quality, has seen a slow pace of adoption within the generic manufacturing sector. This article discusses the challenges and mitigation strategies for adoption of CM by generic drug product manufacturers.

  10. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?