The BioPhorum extractables protocol and portal, and leachables best practices guide
Since 2014 BioPhorum has been working with end users and suppliers to establish effective extractables and leachables (E&L) methods that help the biopharmaceutical industry approve single use systems for use in the safest, fastest and smartest way. In these resource pages you will find descriptions of the key systems, links to the guidance documents and tools to enable suppliers and integrators to provide the vital data and users to organise themselves to use the data to analyse risk in the most effective way.
Although connected and often used as one term, ‘extractables and leachables’, the BioPhorum team has considered extractables and leachables separately in developing its thinking.
For clarity an extractable is a chemical entity that is extracted from a component of a process system into a solvent under controlled conditions that are usually more aggressive than normal operating conditions. Understanding what chemical compounds can be forced out of a polymeric system provides useful information in selecting the most appropriate processing materials and identifying risk. To help suppliers assess extractables in single use systems in a consistent way, the BioPhorum team have developed a standard study and reporting protocol based on a set of solvents and immersion times that simulate the extremes of biopharmaceutical manufacturing. The second version of the BioPhorum extractables protocol ‘Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing’ can be downloaded here.
This protocol was revised and streamlined in 2020 to reflect the latest analysis of data generated through the application of the original protocol. The substance and conclusions of this assessment will be published soon and made available here.
By contrast, a leachable is a chemical entity that comes from single use systems during normal use.
Leachables have the potential to be present in the final drug product. Assessing the risk posed by leachables to deliver safe medicines is a key activity of biopharmaceutical manufacturers. It is also a regulatory requirement.
The BioPhorum ‘Best practices guide for evaluating leachables risk from polymetric single-use systems’ click here, compliments the extracables protocol and guides users through the process of risk assessment, leachables study design, and analytical methods to arrive at final decisions on the suitability of single use systems in those situations where leachable studies are considered a necessary consideration.
Data sharing ecosystem and portal
In 2019/20 the Extractables team has busied itself in creating a data sharing ecosystem to enable suppliers and integrators to make their extractable data available to end users in a readily accessible way. Now you can access this data via the BioPhorum Extractables Portal here.
If other new suppliers and integrators want to add their own data to this ecosystem, there is advice and guidance here on how to create their own landing page and agree to sharing data appropriately with others in the supply chain.