Industry Insights

  1. NEW DOCUMENT
    12/5/2016

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

  2. As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry
    6/2/2015

    Over the last few days at ASCO, multiple studies have shown the remarkable potential of matching cancer therapeutics to specific gene mutations, demonstrating that we are truly entering an age of personalized medicine in oncology. Despite all of the promise, the conference discussions also covered many questions yet to be resolved – by academic centers and pharmaceutical companies, doctors, patients and those of us working in the lab.

  3. A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms
    8/11/2016

    The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

  4. Cell Culture Media: Balancing Resources with Results
    10/16/2015

    It all starts with media. Without an appropriate growth medium, no biopharmaceutical process would exist. The
    proper medium allows for cells to grow and generate product.

  5. CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic
    5/13/2016

    The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world.  With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.

  6. The LAL Test: Precautions To Take When Conducting Research Into Pharmaceuticals
    5/20/2016

    For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL (Limulus Amebocyte Lysate) test. Using the LAL test, the presence of bacterial endotoxins, lipopolysaccharide molecules (LPS) that are part of the cell wall of Gram-negative bacteria, which are the most common and also the most dangerous pyrogens present in the products of the pharmaceutical industry, is determined.

  7. Good Manufacturing Practice: The DNA of Pharmaceutical Quality
    7/16/2015

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. 

  8. Top Considerations For Selecting The Right Packaging
    1/15/2016

    Determining a product’s temperature range is the first crucial step in packaging evaluation. While vacuum insulated panels (VIPs) with phase change materials (PCMs) remain the gold standard of temperature-controlled transport, many high-value products in today’s market have components that require storage at extreme temperatures — as low as -196°C.

  9. Selecting The Optimal Resins For mAb Process Purification
    6/29/2016

    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.

  10. Six Myths About Serialization
    8/12/2016

     Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.