INSIGHTS ON PHARMA LOGISTICS

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

  • Managing Risks To Time Critical Product Imports At Clinical Supply Depots

    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.

  • Innovative Clinical Supply Solutions - Cold Chain

    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.

  • Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs

    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.

More Insights On Pharma Logistics

PHARMA LOGISTICS SOLUTIONS

  • 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.

  • Reduce Cost And Effort When Servicing Clinical Trials In Canada

    Contracting an in-country clinical depot helps bring costs and timelines under control.

  • 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.

  • Your Trusted Packaging And Serialization Partner

    How your manufacturing, packaging, serialization, and clinical distribution can benefit with a contract partner.

  • Brochure: Chemical Synthesis: Small Molecule API Manufacturing

    Chemical synthesis for small molecule manufacturing is one of Lonza's key competencies. While many manufacturers focus their attention exclusively on biologics, Lonza recognizes that chemistry still represents 70% to 80% of the drugs on the market and in late-phase development.

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INDUSTRY EVENTS

Compounding Pharmacy Compliance September 17 - 18, 2019
San Diego, CA
How to Write SOPs That are GCP Compliant and Implementable September 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Understanding and Implementing the EU Regulation for Initiating and Conducting Clinical Trials September 19 - 19, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Smarter Development Of Chromatography Processes September 24, 2019
Time: 11:00 AM Eastern Daylight Time. Duration: 1 hour
Stability Programs – Key Factors in Meeting FDA/ICH Expectations September 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in! October 1 - 1, 2019
1pm-2:00pm EDT, Online Training
Duration:  60-Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Research Project Management - 7 Breakthrough Behaviors For Success October 3 - 3, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!