Monitoring batch processes to ensure the highest level of quality is imperative. While periodic batch process control is the traditional approach to managing consistency end quality, it is recipe-driven.
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.
When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?
It is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle.
Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.
The pharmaceutical market has transformed into a global industry within the span of just a few decades. Many companies have sites across the globe, presenting challenges when it comes to harmonizing process validation approaches among sites. There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary to achieve success.
To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.
Several challenges to single-use adoption remain. These challenges are serious enough to delay or even stop the use of single-use technology.
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages, including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiency, ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and availability of production systems capable of generating high virus titers.
Without careful consideration of what are the most important features you need from a CMO and preparing for what the CMO needs from you, the result can be a mismatch.
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