Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.
The growth of single-use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology is meeting these challenges at every process step and application of biomanufacture.
The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, we’ll demonstrate how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data through partnering with Fisher BioServices and Fisher Clinical Services.
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
Patient-centricity has been a growing trend across the pharmaceutical and biotech industries for some time now. As the focus on precision and personalized medicine continues to increase, sponsors are looking for innovative ways to increase patient enrollment and compliance while reducing drug development timelines and costs. The direct-to-patient (DTP) model has emerged as a potential solution. This model illustrates a means by which a patient is able to receive his or her medication in the convenience of their home. In this article, we’ll share the top three challenges many sponsors face, and how a direct-to-patient pharmacy can provide solutions.
This article offers four predictions from a pharmaceutical packaging solutions company anticipating what will continue to drive change in 2019.
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.
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.
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.
Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
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