The White House 2012 National Bioeconomy Blueprint forecasts that increased cell manufacturing research activities would lead not only to significant improvements in public health, but also provide tremendous economic benefits to the next generation of biotechnologies. Predictably, groundbreaking techniques to elevate quality assurance, increase efficacy, enable production scale-up, and reduce manufacturing and product cost of requisite bioprocesses are needed to support the long-term growth of the regenerative medicine industry.
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.
Proprietary, Clinical Grade HypoThermosol® and CryoStor® Extending Shelf Life and Improving Survival & Function of CAR-T Cells, Dendritic Cells, Etc.
Improvements in the diagnosis and treatment of cancer have led to significant reductions in mortality. This is especially evident by the fact that childhood cancers once fatal in the 1950’s now achieve a survival rate approaching 90%. Despite this tremendous success, overall cancer mortality remains high, and more aggressive treatment regimens are often ineffective and toxic to patients. There is also the ever-present risk that even effective treatment is only temporary, and that the cancer may relapse. Novel technologies and therapies are needed in order to realize future declines in cancer mortality.
With the ever evolving developments in the biopharmaceutical Industry there has never been a greater need for assured Reliability when it comes to the transportation of Pharmaceutical payloads and the guaranteed robustness of Temperature-controlled packaging is proving ever more vital.
Why and how Multivariate analysis and Design of Experiments can make the difference in process automation and quality improvements cases.
The history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution. Also the regulatory guidance that describes where and when to use the mean kinetic temperature calculation: FDA, EMA, and ICH.
We invite you to view a recorded Humidity Measurement Webinar