What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
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.
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.
US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
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.
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.
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.
Protect precious patient tissue blocks from misplacement and loss with the Thermo Scientific™ Syntri™ Arcos™Block Management System. Designed to minimize errors, increase productivity and keep your laboratory’s resources focused on what matters most – positive patient outcomes.
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.
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.