In the life science and healthcare industries the proper storage of temperature-sensitive products – specifically vaccines – is a fundamental and growing concern with respect to public health. Case in point: The Centers for Disease Control and Prevention (CDC) has asserted that few immunization issues are more important than the appropriate storage and handling of vaccines. According to the CDC, approximately 13.5 percent of all refrigerated vaccines are subject to accidental freezing during storage.
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.
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.
Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.
Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.
Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.