BPOG Extractables Protocol & Leachables Best Practices Guide
Although connected and often used as one term, ‘Extractables & Leachables (E&L)’ the BPOG team has considered extractables and leachables separately in developing its thinking in this area. Resources are provided here relating to both Extractables and Leachables (E&L)
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.
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 is a key activity, and regulatory requirement, of biopharmaceutical manufacturers.
Although a distinction is made between an extractable and a leachable, the information on these pages represents a holistic approach to extractables and leachables (E&L) developed by experts from 17 major biopharmaceutical companies.
The Leachables Best Practice guide provides a set of core principles and a practical framework that biopharmaceutical companies can utilise and adapt to meet the needs of their organisation. Utilising best practice from across the industry to evaluate leachables risk in this manner can help with meeting regulatory requirements and ultimately support the production of safe biologically manufactured medicines.
Understanding the extractables profile is a key part of leachables risk assessment. Standardized Extractables testing, which is reported in a standard format allows users to make the right decision when selecting new systems and increases the speed that Single Use technology can be adopted by drug manufacturers.
While the leachables guide is more likely to be of direct relevance to biopharmaceutical manufacturers, SUS suppliers are welcome to review the guide to better understand the considerations biopharmaceutical manufacturers need to take into account when selecting SUS systems. The standardized set of extractables data allows the end user to make meaningful decisions on patient safety.
BPOG member companies, who are part of the Extractables working group are phasing in their standardised extractables testing requirements with their suppliers during 2017. Other drug manufacturers including non-BPOG companies may wish to follow suit and if so, what they need to do so is readily available on this site.
The resources and information is specially tailored to provide single use systems (SUS) suppliers contract research organisations (CROs), regulators and other stakeholders with a common understanding of BPOG member company needs and their consensus position on the application of the standardized extractables protocol in practice.
It provides a one stop shop, a single user voice to answer questions about scope, study design, sample preparation, analytical methods and test reporting. Our aim is to help suppliers by ensuring consistency across the user base and to share useful advice and guidance.
Major single use system suppliers are already moving to adopt the extractables protocol in line with user expectations. This resource should help those major suppliers with their task of ensuring that their own component supply chain companies (sub-suppliers to the biopharmaceutical manufacturers) also understands and meets user extractables testing requirements.
Additionally, these resources help level the field for small suppliers to compete with larger, more established companies when bio-manufacturers are looking to select the right single use component and systems for their needs.