Bioprocessing White Papers

  1. Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up
    3/9/2016

    Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.

  2. Advanced Biofuel Development Using Parallel Bioreactor Systems
    3/9/2016

    To make biofuels such as bioethanol and biodiesel competitive with fossil fuels extensive research in the field of process development is needed. Taking into account the special requirements of biofuel production, such as high temperatures, multi-step procedures and anaerobic conditions, effective tools for streamlining development efforts must be provided.

  3. Changes To GMP Force Cleanroom Reclassifications
    3/4/2016

    According to both USA cGMP and EU GMP cleanroom classification should be carried out according to ISO 14644-1. The 19994 version of this ISO standard has been re-written by a group of international subject matter experts and ISO 14644-1:2015 was published on December 15, 2015. ISO 14644-1:2015 contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification.

  4. The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It
    3/1/2016

    Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.

  5. A Cure For Pharmaceutical Supply Chain Complexity
    2/3/2016

    The complexity that has come with new drugs, innovation in production technologies, and evolving regulatory requirements has caused the pharmaceutical industry’s supply chain to lag in sophistication and performance. In this environment, integrating and aligning the supply chain would make it more flexible, bolstering operational performance and financial competitiveness. So how can this be achieved?

  6. Device Development For Pharmaceutical And Biologic Combo Products
    2/1/2016

    Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered. Read this white paper to learn about the regulatory and clinical development strategies that help define pharmaceutical and biologic combination products, the need for early establishment of regulatory and clinical strategies, and how to best understand user needs and determine product requirements.

  7. Human-Centred Design And Inhalation Device Development
    12/22/2015

    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.

  8. 6 Guidelines To Follow When Developing Combination Products
    12/15/2015

    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.

  9. Systems Engineering For Complex Portable Medical Device Development
    11/2/2015

    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.

  10. Eliminating Variability: The Solution To Temperature-Sensitive Pharmaceutical Sampling
    10/23/2015

    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.