Bioprocessing White Papers

  1. Human-Centred Design And Inhalation Device Development

    Human-centred designs have become a driving trend in the development of next-generation inhalation devices, making them more useful, usable, and desirable than current inhalation devices. By applying design research, industrial research, and human factor disciplines in cooperation with design for manufacturing and assembly philosophy, patients are able to receive inhalation devices that minimize opportunities for error, and support greater adherence to their prescribed therapy.

    This white paper describes Phillips-Medisize’s approach to human-centred design in producing the next generation of smaller and smarter inhalation devices.

  2. 6 Guidelines To Follow When Developing Combination Products

    While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.

  3. Systems Engineering For Complex Portable Medical Device Development

    As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.

  4. Eliminating Variability: The Solution To Temperature-Sensitive Pharmaceutical Sampling

    This paper identifies the challenges of temperature-sensitive drug transportation and evaluates systems available to help reduce variability in order to preserve product quality and improve business efficiencies.

  5. Wireless Dose-Compliance Monitoring In Drug-Delivery Devices

    Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm. Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.

  6. Best Practices In Supply Chain Management: A CMO Perspective

    Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.

  7. Key Considerations When Choosing A Partner For Drug Discovery

    The changes in the economic landscape and pipelines over the last 10-15 years have resulted in drug developers in companies of all sizes to take a hard look at their strategy and operations.

  8. Losing Everything: Are Chart Recorders Enough?

    Perhaps, unfortunately, this scenario is all too familiar: You arrive at work on Monday morning and hear an alarm sounding from your refrigerator. You walk over to your fridge to check the chart recorder and see abnormal spikes on the paper graph, but a detailed analysis by quality control personnel is required to take any action whatsoever. You find out that the chart doesn’t show enough data for a quality-based decision, so the product inside has to be discarded. Panic sets in. The monetary value of the supplies pales in comparison to the fact that patients today are relying on the medicine inside.

  9. A Case for Co-Sourcing Laboratory Services

    Many industry observers believe the need for responsive, collaborative, and tech-savvy partnerships is paramount in the new emerging business environment. Success or failure in this environment will be defined by operational agility to research, adapt, produce, and deliver products rapidly under fluctuating market conditions. 

  10. Managing Laboratory Consumables

    Since All I Really Need to Know I Learned in Kindergarten first appeared in 1988, its simple, profound wisdom has inspired the world. Among its easily digested messages are a few gems that research scientists would do well to employ in their labs every day: Share everything, Play fair, Put things back where you found them, CLEAN UP YOUR OWN MESS, Don't take things that aren't yours.