By Randy Wilkins and Matt Daley, MilliporeSigma
According to a recent report from the Tufts Center for the Study of Drug Development, the total price tag for bringing a new drug to market can be up to $2.7 billion.1 While development costs are high, keeping costs low during commercial production while delivering products that are safe for human use are key components of market success.
Over the past decade, there have been major improvements in process understanding that have resulted in more efficient processes that meet market demands for high-volume, blockbuster therapies. Improvements have also been made in the efficiency of small-volume, microscale processes to the point where patient-specific therapies are a reality. To help meet the needs of both large- and small-scale processes, suppliers of sterilizing-grade filters have developed new products and technologies and, in some cases, optimized existing products by creating new sizes or formats. Although the fundamental function of sterilizing-grade filters is to control bioburden and provide sterility assurance, there are many more filtration product offerings today that can improve efficiency and expand flexibility in process design.
Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes. These trends have adjusted expectations for both suppliers and manufacturers by providing confidence and safety assurance for their products.