Featured Articles

  1. 5 Key Factors For A Successful Tech Transfer

    Each tech transfer comes with a unique set of complex processes that need to be understood. While it includes the transfer of analytical methods and manufacturing processes, there is also a human dimension to consider.

  2. Vaccine Capacity Musical Chairs

    In the past six months, I’ve spoken to more vaccine developers than I have in the previous eight years, all of them searching for production capacity. Has the music stopped? Is it time to grab a chair?

  3. Meet The Scientist — Sundeep Sethia, Ph.D.

    Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.

  4. The Value Of Orphan Drug Designation

    More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

  5. Oral Solutions & Suspensions: The Art Of Pharmacy 5/12/2022

    Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

  6. The Importance Of Analytical R&D To Sterile Fill/Finish

    Parenteral drug product development and production rely on the careful integration of supporting elements, with analytical support as key. Analytical support is required at all stages of the product’s life cycle, from early development to commercialization.

  7. 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.

  8. Accelerating The Start Of Your Outsourced Pharmaceutical Project: Role Of The Project Technical Review -- Part 2

    Part 2 in this series focuses on the gap between project tech review and the assessing a potential CDMO's capabilities and anticipated project timing to determine necessary resources and outline deliverables.

  9. Accelerate The Start Of Your Outsourced Pharmaceutical Project

    In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).

  10. Tech Transfer For Oral Products

    With the right CDMO, a proper tech transfer offers an opportunity to re-examine quality, process procedures, and supply chain issues, including provider partnerships.