Integrated single-use freeze-thaw assemblies with reliable component parts, such as the connectors supplied by CPC, have become the primary implementation choice for achieving successful drug substance transfers between manufacturing facilities.
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.
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.
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.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
This video demonstrates how the VIA Thaw CB1000 can standardize a critical step in the delivery of cell therapies with a simple, reproducible and traceable process for recovering cryopreserved samples in cryobags.
A video introduction on the VIA Freeze™ range which are liquid nitrogen-free controlled-rate freezers to cryopreserve any type of samples.
An overview of the regulatory requirements given in the latest guidance documents as well as a description of new technologies for determining the identity of cell substrates and virus seed stocks and detecting adventitious agent contamination.
Rapid growth and geographic expansion in the biopharmaceutical market is increasing supply chain risks that need to be well understood.
Thermo Scientific™ Nalgene™ containers are made with high-quality resins that meet pharmaceutical, laboratory, and food grade standards. Choose from a wide range of quality carboys and jerricans to fit your application requirements—from collecting and mixing reagents, media, and bulk vaccines to storing active pharmaceutical ingredients.
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.
Safe and reliable handling & shipping solutions