Industry Insights

  1. Clinical Supply Chain Transformation Through Innovation

    Even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?

  2. Tips On Selecting A Liquid Chromatography Resin

    There is a wide array of chromatography resins available to address the evolving needs of researchers purifying a diverse set of target molecules.

  3. CMO and Biosimilars Producer, Alvotech, Discusses Design for Success

    In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors.  The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process.  The result:  A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System. 

  4. How To Avoid 5 LIMS Nightmares

    Analysts have estimated the failure rate of commercial laboratory information management systems (LIMS) to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

  5. 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.

  6. Pharmaceutical Primary Packaging Strategies

    There are several factors that biopharmaceutical companies should take into account when considering outsourcing primary packaging. This article provides an in-depth look at the benefits of developing packaging strategies as early as possible in the drug development process, how primary packaging should be approached to ensure patient compliance, and different forms of packaging that best protect and improve the stability of a product.

  7. Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  8. The Impact Of Waste On The Cost Of Quality In The Pharma Industry

    Waste has a significant impact on the cost of quality (COQ) — or more exactly, the cost of poor quality — in the pharmaceutical industry.

  9. 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.

  10. Building Efficiency Through Continuous Characterization And Connected Bioprocessing

    Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.