Industry Insights

  1. Considerations To Ensure Successful Scale-up Of Single-use Processes
    11/12/2015

    Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.

  2. What’s Next For Single-Use Technology In Bioprocessing
    3/10/2016

    The advantages of single-use are well-known — faster, smaller, greener, cheaper, and safer — and increasing numbers of biomanufacturers have sought to reap these benefits, especially as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.

  3. 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
    3/29/2016

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  4. CDMOs — At The Core Of Next-Generation Pharma Models
    5/2/2016

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  5. Ensuring Barcode Accuracy From Packaging To The Patient
    5/13/2016

    Barcodes have changed very little over the last 60 years. Yet for pharmaceutical companies the barcode has taken on a vital role throughout the product’s lifecycle from original packaging to in hospital unit dose identification.

  6. How Do You Inspect Packaging Of Bottles, Cans And Cylinders?
    5/13/2016

    To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.

  7. Changes To The Opioid Labeling Regulation
    5/13/2016

    The statistics on opioid abuse in the United States is grim. In 2014, Opioids were responsible for 28,648 deaths according to the CDC. In fact, more people died of drug abuse that year than did of motor vehicle accidents. Worldwide the statistics are not any better; it is estimated that between 26.4 million and 38 million people abuse opioids.

  8. Digitally Transforming Laboratory Operations
    5/20/2016

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.

  9. Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    5/20/2016

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

  10. Avoiding Collaboration Failure In Bio Pharma: Is It Possible? With The Cloud It Is.
    5/20/2016

    With the drug patent cliff continuing to cast a long shadow over biopharma, the industry is radically reinventing itself by embracing globalization and focusing on innovation and operational excellence. Most importantly, biopharma organizations are expanding externalized collaborative relationships beyond traditional boundaries and creating flexible networks of researchers — some in-house, others with industry and academic partners, research institutes and contract research organizations. These networks are increasing in size and complexity with many combining numerous partners with diverse project objectives. Externalized projects like this raise important data security and project management challenges.