INSIGHTS ON PHARMACEUTICAL LOGISTICS

• Conducting The Advanced Therapy Supply Chain Orchestra

  Conducting the advanced therapy supply chain orchestra is more than waving a stick at people – it is an “end to end”, complicated, inter-related system that requires controlled, consistent management. Following are some things you need to think about to develop the capability to provide a harmonious supply chain management system.

• Securing Bioprocess Film Supply

  Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.

• 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.

• 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.

• Importance Of Chain Of Custody Documentation For Biologics

  Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.

• Determining Optimum Maintenance Temperature For Advanced Therapies

  In this article, we’ll discuss four areas that need to be understood to determine the optimum maintenance temperature for advanced therapy material.

• 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.

• Scaling The Advanced Therapy Supply Chain

  Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

• Quick To Clinic™ for Oral Solid Dose

  In as little as 14 weeks from receiving your small molecule API, you can have your Phase I drug product manufactured, labelled, packaged and delivered to the clinic. That’s 1 month faster than most standard timelines, and includes a one-month stability study.