Industry Insights

  1. Patient-Centric Drug Design — A Clinical And Academic Perspective

    Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and  improvements in pediatric drug development.

  2. Selecting The Optimal Resins For mAb Process Purification

    The development of monoclonal antibody (mAb) technology over the past 25 years has fundamentally changed the questions we ask and led to many innovative discoveries. These highly specific biological products have significantly influenced the direction and progress of research and therapeutics.

  3. Why Early Investment In A Scalable Manufacturing Process Is Critical

    The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.

  4. Solutions To Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to today’s challenges.

  5. RABS vs. Isolator – Technology and Applications

    Considerable confusion still surrounds the terms barrier, Restricted Access Barrier System, and isolator and their respective suitability and favorability in pharmaceutical fill-finish operations. 

  6. Meeting The Challenges With Complex Biomolecules In Modern Vaccinology

    Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.

  7. Critical Factors Of Fill/Finish Manufacturing For Biologics

    Unlike small molecule drugs, biologics are extremely sensitive, and therefore require specific handling procedures throughout the manufacturing process.

  8. Following FDA Guidance: Continuous Improvement In An Outsourced Environment

    In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”

  9. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies

    When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?

  10. Principles On Which The Limulus Test For The Detection Of Bacterial Endotoxins Is Based

    The LAL or Limulus test is used for the determination of bacterial endotoxins in a wide variety of samples. In this article, the biological process and the way it was used to develop the test is described.