Industry Insights

  1. Can Assumption-Free Batch Modeling Eliminate Processing Uncertainties?

    Monitoring batch processes to ensure the highest level of quality is imperative. While periodic batch process control is the traditional approach to managing consistency end quality, it is recipe-driven. 

  2. The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  3. Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.

  4. The Next Generation Of Bioprocess Engineering: Bringing A Perspective From The Last Two Decades

    The increasing complexity of bioprocess engineering has driven a shift toward cell biology and away from process engineering.  Cell types have become more diverse, the science more complex, and genetic modifications more common, all while products are becoming more targeted and cost effective.   What should we expect to see from industry and academia to keep the field moving forward?

  5. Development Of A Two-Column Manufacturing Process For Adenovirus

    Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages, including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiency, ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and availability of production systems capable of generating high virus titers.

  6. 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.

  7. Flexible Mobile Biocontainment Units Prevent Spread Of Transmissible Diseases

    There exists two key methods for controlling serious outbreaks of transmissible diseases: therapeutic countermeasures and transmission control through isolation and containment.

  8. Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

    Molecules continue to get more challenging from the perspective of solubility, bioavailability, and exposure. Advances in formulation technologies continue to provide more solutions. Establishing effective communications between DS chemists and DP formulators manage the risks and maximize the rewards of transforming less soluble and less bioavailable molecules into effective new drugs.

  9. Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

    The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself.

  10. 5 “No-Cost Strategies” For Your Laboratory Project

    The list is a guide to identifying practical strategies and making a project successful from inception to the operations and facility life-cycle by incorporating more science into less space, reducing utility usage, and using innovative concepts.