Industry Insights

  1. Business and Cultural Considerations When Managing Clinical Supplies for Asia-Pacific Studies
    2/8/2018

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  2. Four Steps To Conducting A Successful Data Integrity Audit
    9/8/2016

    A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification.

  3. Useful Tips For Fab Protein Purification
    1/21/2017

    While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets.

  4. Driving Change of Implementing In-Line Conditioning
    2/1/2018

    The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.

  5. A Consultant's Guide To Flexible Biomanufacturing Solutions
    5/26/2017

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. 

  6. Implementing A Total Quality Strategy In Life Sciences
    5/23/2016

    According to over 200 life sciences companies surveyed, the number one challenge in speeding products from R&D to patients is quality management, which may surprise many executives that have spent the past decade focused on other issues like validation, regulatory, or supply chain.

  7. Cost Savings And Speed: The Untapped Value Of A Single-Source Solution
    9/7/2017

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  8. Avoiding Delays In Clinical Supply
    3/6/2018

    How sponsors can work effectively with clinical suppliers for accurate forecasting and comparator sourcing to avoid delays in clinical supply.

  9. Which Test Is Appropriate For Container Closure Integrity?
    2/2/2017

    Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.

  10. Challenges, Risks And Strategies For Biologic Substance Manufacturing
    7/20/2016

    From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.