Industry Insights

  1. Harnessing The Hype: Can AI And Other Tech Make Patients Better Faster?

    Artificial intelligence (AI), blockchain technology, predictive analytics, cloud computing, and speech and image recognition are the latest buzzwords across industries. Numerous companies are looking to inject these technologies into their operations, and a great deal of funding is pouring into related startups.

  2. Help! My Isolator Is Taking Too Long To Degas — What Should I Do?

    Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

  3. An Overview Of FDA's New Guidance On Long-Term Follow-Up After Administration Of Gene Therapies

    The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the third article in a six-part series.

  4. What Should You Do After An FDA Inspection?

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  5. 10 Simple Steps To Selecting The Right CMO

    Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.

  6. Four Steps To Conducting A Successful Data Integrity Audit

    A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification.

  7. Part 3: Don't Put Your Company At Risk: Be Prepared For eDiscovery
    They say ignorance is bliss. Maybe that is true in some cases, but not where eDiscovery is concerned. By Vicki Amendola, featuring Bryan Reynolds, CEO, Sitrof Technologies, Inc.
  8. A New Process For Reducing Glass Breakage

    Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination and loss of sterility.

  9. Comment On Biopharmaceutical Classification System And Formulation Development

    This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD

  10. Indian Biosimilar Market Analysis — What Can We Learn?

    Although the biosimilar space is still growing and evolving in the U.S., it is comparatively well-established in India. As such, the country can provide valuable lessons about what it takes to establish a thriving biosimilar market in terms of accessibility, competition, regulatory strategy, and other facets.