Insights On Manufacturing Logistics

  1. What Clinical Teams Should Know About The Benefits Of Auto-Injectors
    8/20/2019

    For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.

  2. The Evolution of Public Health Research: The Next Frontier
    6/28/2019

    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.

  3. "Validation" Or "Qualification" – What’s The Difference?
    6/25/2019

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

  4. Storing Biologics At Non-Traditional Temperatures
    6/21/2019

    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.

  5. Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?
    6/19/2019

    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.

  6. Top Considerations To Meet FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies
    6/14/2019

    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.

  7. The Importance Of Inventory Management: Do You Know Where Your Samples Are?
    6/12/2019

    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.

  8. Managing Risks To Time Critical Product Imports At Clinical Supply Depots
    6/11/2019

    Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

  9. Innovative Clinical Supply Solutions - Cold Chain
    6/11/2019

    With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.

  10. Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs
    6/10/2019

    While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated.  In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.