Formulation
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November 21st 2024
The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.
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The challenge of 21st century influenza
March 1st 2008Conventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.
The Importance of Leachables and Extractables Testing for a Successful Product Launch
January 2nd 2008FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
Aspects of process development for virus vector production to improve quality and quantity
January 1st 2008The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..
