Industry Insights

  1. The Importance Of Primary And Secondary Drying And Their Impact On Lyophilization 3/25/2025

    For parenteral formulations, biologics, and vaccines, the lyophilization process's primary and secondary drying stages require precise control of temperature, vacuum, and duration. 

  2. How To Improve CAPA Metrics 10/13/2022

    A CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.

  3. Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

    Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

  4. 6 PEG Alternatives You Should Be Thinking About 11/22/2023

    PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.

  5. Accelerating Multi-Specific Antibody Development, Manufacturing

    Discover strategies to overcome challenges and meet the demand to accelerate the speed to clinic of multi-specific, multi-chain new molecular format therapeutics.

  6. Exploring The Market For Closed-Loop Cell Therapy Production 6/18/2025

    The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.

  7. Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity 11/4/2020

    Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants. 

  8. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

    The quality culture of the organization has a clear and direct impact on the ultimate quality of the product. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

  9. Quality And Manufacturing System Implications For Cell And Gene Therapy 4/7/2022

    We review way to improve the manufacturing and quality assurance for gene and cell therapy products by using digital manufacturing execution systems (MES) and quality management systems (QMS).

  10. Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book 7/12/2021

    The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.