Industry Insights

  1. Optimizing Filling Technology To Minimize API Loss

    New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

  2. Can We Eradicate Tech Transfer? 9/23/2020

    While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

  3. Organ-Chips: A Promising Model For Human Emulation 4/9/2024

    Organ-Chips offer more accurate assessments of safety and efficacy readouts compared to other cell and animal models used by academia, government, and pharmaceutical entities to study drug toxicity.

  4. Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity 2/23/2023

    Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.

  5. Prioritize Solvent Recycling And Recovery To Realize Your Green Goals

    Building more sustainable practices across the pharmaceutical industry takes a collaborative and transparent effort. One leading CDMO is leveraging its solvent recovery efforts to yield major strides.

  6. Establishing Flexibility For Parenteral Cleanroom Manufacturing

    Cleanroom systems are purposely designed to simplify the implementation of the aseptic manufacturing space that the industry needs to meet future sterile injectable capacity demand.

  7. Addressing Complex Challenges And Developing Innovative Solutions 7/8/2024

    Explore two projects that a focus on improving efficiency and productivity in biopharmaceutical manufacturing while reducing the cost of goods through process intensification.

  8. A Quality Agreement Primer: Managing Risk When Working With Contractors 10/2/2020

    This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

  9. Embracing Turnkey And Outsourced Quality Management In Biopharma 3/28/2025

    In-house quality management systems often struggle to keep pace. Many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance and enhance efficiency.

  10. Leveraging Target Product Profiles To Optimize Portfolio Potential 8/8/2022

    This guide discusses the critical role of target product profiles (TPPs) in product development and offers tips and best practices for integrating these tools into and across programs to optimize portfolio potential.