INSIGHTS ON MANUFACTURING LOGISTICS

  • The Evolution of Public Health Research: The Next Frontier
    The Evolution of Public Health Research: The Next Frontier

    Public health and medical research occasionally take unexpected turns that allow us to glimpse new wonders into the world we inhabit. After the scientific community had accepted Pasteur’s germ theory of disease, discoveries in microbiology increased exponentially, including Robert Koch’s use of agar in 1876 as a culture medium to isolate specific micro-organisms.

  • "Validation" Or "Qualification" – What’s The Difference?

    What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

  • Storing Biologics At Non-Traditional Temperatures

    Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this article, we’ll explore some of the reasons why this is occurring and the associated challenges.

  • Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?

    The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature data and chain of custody in handling is imperative to the pharmaceutical industry of today.  These additional factors partly explain the much higher cost of these therapies as well. The three primary issues are: capacity, regulatory, and risk. We’ll look briefly at all three.

  • Top Considerations To Meet FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies

    US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

  • The Importance Of Inventory Management: Do You Know Where Your Samples Are?

    With the exciting advances in research and drug development, the importance of sample management has never been higher. If you have ever experienced sample management mishaps, we ask: Do you know where your samples are? In this article, we’ll explore some of the common causes of inventory mismanagement and best practices to guard against sample loss and near misses.

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MANUFACTURING LOGISTICS MULTIMEDIA

  • How One Split-Second Decision Made A Difference For Thousands Of Patients
    How One Split-Second Decision Made A Difference For Thousands Of Patients

    In the world of drug manufacturing not all life-saving decisions happen in the lab. Sometimes it’s a lot closer to delivery that key moments require fast thinking. Such as one Saturday morning in Memphis, TN, when Marcus noticed the freezer temperatures were out of range. With over 2,000 cold chain shipments leaving his facility per day, he couldn’t afford to lose a week’s supply due to warm temperatures. As the repair crew worked on the issue, Marcus knew it wasn’t an easy fix and he needed a backup.

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MANUFACTURING LOGISTICS SOLUTIONS

  • Catalent Biologics
    Catalent Biologics

    Catalent Biologics is your one integrated partner with expertise to get your biologic to market faster. We have the passion to help you accelerate, simplify and de-risk your next biologic from development and manufacturing, to fill/finish, clinical supply and commercial launch.

  • Catalent Clinical Supply Services
    Catalent Clinical Supply Services

    Whether you have a large, complex global study or need a small, regional solution, we can reliably supply your clinical trial anywhere in the world. From Phase I to Phase III and beyond, we are the catalyst for your success.

  • Ibex™ Design

    The demand for biopharmaceutical products is continuously growing to serve the needs of an aging global population and the prevalence of chronic diseases. At the same time, the environment for biopharma companies is complex and challenging, with novel regulatory pathways, requirements to accelerate patient access, and rising competition.

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