From a historical perspective, there are millions of FFPE tissue blocks in storage and in use today. Most storage process work well for small numbers of samples, but is quickly overrun when thousands of blocks begin to accumulate. A new end to end system has been developed and implemented in several locations worldwide to address the issues encountered with FFPE block storage, retrieval and restocking.
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.
One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.
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.
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.
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.
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.
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.
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.
Thermo Scientific Versa Flex warehouse scales are ideal for weighing mailers, totes and cases.
Sartorius Stedim Biotech offers comprehensive solutions, using either patented freeze-thaw technologies or conventional freezers, for the handling, storage, transfer and shipping of biopharmaceuticals.
As your clinical material partner, we simplify – and accelerate – your clinical trials. From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.
Changes to the protocol such as dosage changes, increases or decreases in volumes, changes to expiry dates, or inclusion/exclusion of countries that weren’t part of the original plan can impact clinical trial packaging. You need a partner that can help you accurately identify and predict issues that might impact schedules, while remaining nimble to adjust to changes. Read how Fisher Clinical Services can serve as a trusted advisor to help you strike the best balance of cost, time and quality.
Ropack Pharma Solutions is positioned to warehouse and distribute even the most sensitive products.