Biopharmaceutical manufacturers have an obligation to ensure the safety and efficacy of the products they produce. This requirement drives the selection of products and materials used in manufacturing operations and defines the necessary risk assessment of those materials.
One of the areas of concern are the chemicals that can be extracted from cell culture vessels and other containers used in the storage and manufacture of the pharmaceutical. To mitigate these risks, biopharmaceutical manufacturers often use extractables data to perform a risk assessment to determine if they need to take action to reduce risk or if further studies are required. These studies are performed using conditions that are exaggerated to ensure that the list of potential extractables is comprehensive.
Suppliers can assist manufacturers by incorporating an understanding of extractables into the design of their products. Not only is the selection of materials important, but designing products in a way that minimizes the number of materials can reduce the amount of time it takes to assess risk and help save manufacturers’ time. The more individual materials you incorporate into a product design, the greater the potential to increase the number of extractables observed.