Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.
Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
Mycoplasma maybe the smallest class of free living microorganism, but the consequences of a contamination in a cell batch during bioprocessing can be huge.
This case study explains how Parker Domnick Hunter (a division of Parker Hannifin) helped a pharmaceutical company optimize cell density in cell culture tanks that needed to be converted into fermenters to grow E. coli bacteria.
The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.
Biorefineries have reignited interest in anaerobic fermentations with biobutanol production being the principle driver. Already during the First World War Biobutanol and acetone were produced in Clostridium acetobutylicum.
Marken collected a shipment from southern Sweden that was bound for next-day delivery in northern Belgium. However, all airline flights into Belgium were cancelled as a result of a strike action by airport workers.
The Multifors Cell can be used to easily optimise development processes by parallel cultivation of animal cell cultures. Cultivation of the CHO (Chinese hamster ovary) cell line in the Multifors Cell bioreactor (INFORS HT, CH-Bottmingen) is described in the following as an example of batch cultivation of parallel samples.
The GS1 Healthcare US Secure Supply Chain Task Force, consisting of more than 50 members from throughout the supply chain, has developed a guideline to identify and serialize pharmaceutical products using GS1 identification numbers. The guideline titled “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace” enables pharmaceutical companies to trace the movement of products through the U.S. pharmaceutical supply chain.
Recently, the Ministry of Health issued the New GSP, which will be effective fromJune 1st, 2013. The improvement of the Pharmaceutical Cold Chain is one of the main goals.
The IP & Science business of Thomson Reuters, the world's leading source of intelligent information for businesses and professionals, today announced the publication of a new report that provides a comprehensive view of the potential effects of personalized medicine on drug research and development.
GBI Research, the leading business intelligence provider, has released its latest research "Cell Culture - Rising Demand for Biologics and Growing Visibility of Approval Pathway for Biosimilars will Create Growth Opportunities", which provides in-depth analysis on the processes, drivers and barriers of the cell culture market.
Sigma-Aldrich® Corp. announced that Sigma Life Science, its innovative biological products and services research business, has launched Stemline® Pluripotent Culture Medium, a novel human pluripotent stem cell culture medium that provides a consistent environment for the long-term maintenance and growth of healthy pluripotent stem cells.
CPhI introduces Nano Suspensions India 2012 which will be focusing on the most relevant and pressing issues around regulatory, QbD, solubility, stability and efficient scale-up of nano medicines.
Sigma-Aldrich® Corporation (Nasdaq: SIAL) today announced that Sigma Advanced Genetic Engineering (SAGE) Labs, an initiative of Sigma® Life Science, extended CompoZr® Zinc Finger Nuclease (ZFN) technology to achieve the first tissue-specific conditional knockout of an endogenous gene in rats.
ColdChainIQ.com the online network and content resource designed exclusively for the temperature control supply chain life science industry has relaunched with a brand new design and identity.