By Stephanie Ferrante and David Beattie, MilliporeSigma
Biologics development and manufacturing is inherently complex and challenging. Compounding this is the added pressure to be first to market in a highly competitive healthcare landscape, where delays can put the success of a product and company at risk. The implication for process development engineers is that they are tasked with rapidly designing a purification process for a drug product that meets safety and quality standards for human use.
In the growing market of biologics, the sterile filtration of liquids is a key component of many operations. This step is vital to minimizing microbial contamination and ensuring product safety and integrity. Preventing microbial contamination in upstream processes reduces the risk of bioreactor contamination and subsequent business disruption. Selecting the right filter for downstream processes can significantly impact operational efficiency and cost. Understanding the different criteria for optimum filter selection helps narrow the options and streamlines product selection.
Technological innovations have opened the doors to many new approaches to drug development. Progress has also been made in the development of improved technologies for producing and manufacturing biologics. Advances in membrane technology and device design have resulted in new options for sterile filtration. Rather than a traditional one-size-fits-all sterilizing filter, more specialized filters have been developed for optimum performance in specific unit operations or with particular fluid streams.
Opportunities to consider and evaluate new filters most often occur in either the early stages of process development with a new molecule, or after approval when there is a change to production processes. By choosing a filter that best fits the goals of the process, it is likely to be reliable, sustainable, and scalable for the life of your drug product.