Industry Insights

  1. Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities
    6/18/2018

    By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

  2. Could A Fear Of QbD Slow Your Breakthrough Therapy Drug’s Speed To Market?
    8/16/2017

    As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.

  3. Targeted Therapies Drive Need For Flexible, Small-Volume Manufacturing
    5/2/2018

    Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.

  4. Route Scouting In API Development: A Luxury Or Necessity?
    3/29/2017

    Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.

  5. How To Rapidly Create Single-Use Biomanufacturing Capacity
    6/8/2017

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

  6. Doubling Up For Speed: Using Parallel Operations In Biopharma Manufacturing
    6/21/2018

    One solution to drug development challenges is adopting a parallel operations business model. This article offers recommendations for how parallel operations can be leveraged in a biomanufacturing strategy.

  7. What Does The Deferment In The DSCSA Deadline Enforcement Mean For You?
    9/12/2017

    Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.

  8. Avoid The Fallout From Incompatibility Between Your API And Its Formulation
    8/2/2017

    It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.

  9. 4 Ways To Avoid Failure In Phase III Clinical Manufacturing
    9/19/2018

    Understanding the challenges in the biopharma space is critical, as the planning you do today dictates the options you have later when the costs — and the stakes — get even higher.

  10. Bioburden Sources You Might Have Missed
    5/3/2017

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.