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.
Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. In the United States, one of those channels is to have Pharmaceutical Sales Representatives ‘hand carry’ samples to the health care practitioners within their territories.
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.
Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.
Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.
Overcoming the challenges of manufacturing and administering a complex product to any patient is critical for delivering cell therapies. Two industry experts detail strategies to meet supply chain challenges.
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.
Learn more about how free trade zones can offer cost-efficient ways to manage your clinical trial.
See how this service can benefit you with shorter lead time, less waste, less stock out risk and no booklet labels.
How utilizing a global network of leading manufacturers, wholesalers, and carefully selected QA-qualified healthcare professionals can provide cost-effective access to virtually any product.
Hear insights from Sam Herbert, president of World Courier, regarding how the evolution of the supply chain in traditional small and large molecules is a handoff from clinical partners into commercial partners.
Do you need a contract development and manufacturing organization (CDMO) that will fill the gaps in the drug development process and focus on getting patients the treatments they need faster? Read how the team of experts at Singota is here to collaborate with you, customizing our services to meet your needs and hit your milestones.
How your manufacturing, packaging, serialization, and clinical distribution can benefit with a contract partner.
This fact sheet offers insight into our logistics solutions for high value/high risk shipments. Download it to learn more about our consultative solution design focused on defining client and situation-specific solutions, driving cost savings, and reducing time-in-transit.