For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
Public health and medical research occasionally take unexpected turns that allow us to glimpse new wonders into the world we inhabit. After the scientific community had accepted Pasteur’s germ theory of disease, discoveries in microbiology increased exponentially, including Robert Koch’s use of agar in 1876 as a culture medium to isolate specific micro-organisms.
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.
With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.
Catalent Biologics is an integrated partner with expertise to get a biologic to market faster. The company has the passion to help its partners accelerate, simplify and de-risk their biologic therapies -- from development and manufacturing, to fill/finish, clinical supply and commercial launch.
Whether you have a large, complex global study or need a small, regional solution, we can reliably supply your clinical trial anywhere in the world. From Phase I to Phase III and beyond, we are the catalyst for your success.
The demand for biopharmaceutical products is continuously growing to serve the needs of an aging global population and the prevalence of chronic diseases. At the same time, the environment for biopharma companies is complex and challenging, with novel regulatory pathways, requirements to accelerate patient access, and rising competition.
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.