Industry Insights

  1. As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry

    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.

  2. A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

    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.

  3. Cell Culture Media: Balancing Resources with Results

    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.

  4. Tips For Preparing Process-Scale Chromatography Columns

    Column chromatography has been used for many years to successfully characterize, purify and manufacture products for the food and drug industries. Scaling up from laboratory-scale to process-scale purification is one of the most important manufacturing activities for the pharmaceutical industry. However, many challenges exist in this activity. Some issues start with column selection and transitioning the workflow protocol smoothly. Columns range in size from a few millimeters in diameter for laboratory-scale to two meters or more for process-scale. With larger diameter columns, issues with irregularities in media packing, pressure and flow can occur. Here we discuss a few key considerations when transitioning from small to larger-sized columns.

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

    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. Which Test Is Appropriate For Container Closure Integrity?

    Container closure integrity (CCI) testing is receiving more attention these days. In fact, the recently revised USP< 1> Injections and Implanted Drug Products (Parenterals)-Product Quality Tests, specifies that “the packaging system should be closed or sealed in such a manner as to prevent contamination or loss of contents.

  7. Top Considerations For Selecting The Right Packaging

    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.

  8. Finding Solid Ground In New Markets

    In the recent Economist Intelligence Unit survey on biopharma’s present and future, biopharma industry leaders expressed excitement and some uncertainty about the emerging markets of the Middle East and Africa. Respondents saw great opportunity in these regions, but also cited potential risks in relation to regulatory questions and stability issues. We spoke with Bert de Vet, Head of Commercial EMEA Process Solutions at MilliporeSigma, about his take on growth in the region and some of the ways companies entering these regions can mitigate risk.

  9. Why Data Liquidity Is Your Company's New Business Objective

    How to merge ECM, BPM and archiving strategies so data and analytics power the content lifecycle.

  10. Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.