There is growing interest among consumers in verifying that the dietary supplements they take are safe and efficacious. The concern over whether consumers are getting the product as it is described on the label is rooted in one vital and transformative fact: probiotics are living organisms that are highly sensitive to humidity and oxygen. In the absence of proper handling and packaging, the efficacy of probiotic products can be compromised at any point of the packaging, storage and transportation process, inversely impacting shelf life and product viability and efficacy for the consumer.
This video provides insight into Thermo Fisher Scientific’s primary and secondary packaging of clinical trial materials at the Horsham, UK site. This site also specializes in automated global distribution and in Cold Chain Management.
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.
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.
Chemical synthesis for small molecule manufacturing is one of Lonza's key competencies. While many manufacturers focus their attention exclusively on biologics, Lonza recognizes that chemistry still represents 70% to 80% of the drugs on the market and in late-phase development.
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.
Lonza is the industry leader in development, manufacturing and commercialization services for cell-based therapeutics.
How your manufacturing, packaging, serialization, and clinical distribution can benefit with a contract partner.