Clinical supply chains today must quickly and cost effectively ship expensive, temperature-sensitive materials around the world. Faced with these pressures, service providers have adopted new logistical approaches to increase the speed and flexibility of supply chains and bolstered their problem-solving capabilities to better support clients. In this article, experts discuss how sponsors can leverage these resources to expedite trials.
Manufacturers and shippers of these products are under increasing pressure, as pharmaceutical and life science logistics becomes more complex and as the consideration towards better control of falsified medicines increases.
The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
Your security strategy isn’t simple anymore, but that doesn’t mean it can’t be smart. As the industry has grown and changed, the pharmaceutical supply chain has become more global, introducing new vulnerabilities at each and every stage.
The loss of ingredients could trigger regulatory or legal liability, negative news coverage and a backlash from consumers criticizing your brand on social media. This is just one example of a potential risk your company’s global supply chain faces.
Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.
The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.
In this webinar you will learn how to maintain data integrity in environmental monitoring applications. Participants will get an up-to-date overview of the current regulatory expectations for practices that ensure data integrity.
Watch the on-demand webinar and discover InTemp from Onset - an entirely new, fully-integrated, end-to-end temperature monitoring technology for Good Distribution Practices in the pharmaceutical supply chain.
New therapeutic products require new technologies, capabilities, resources and a thorough understanding of how temperature impacts preclinical and clinical studies and commercialization of regenerative medicines.