U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

extractables/leachables for single-use systems in biologics manufacturing

As utilization of single-use systems continues to rise, so do the risks.

There are compounds known to be present in single-use systems (SUS) whose breakdown products are known to inhibit cell growth. This can result in lot-to-lot variability, low yields and loss of expensive cells. The industry now has a better understanding of these concerns, and the manufacturers of single-use products work to reduce or eliminate these chemicals in their products. However, it’s still important to understand the potential presence of these chemicals and to mitigate those risks. Risks are not limited to cell growth, the chemicals that may be leached from the plastics in these systems into the final product can lead to potentially serious safety issues for patients.

There are NO current specific regulatory requirements for single-use systems.
Without regulations, how do you address concerns?


Ensure complete characterization

There are several schools of thought regarding the approach to testing with different extraction solvents, conditions and timepoints. In the end, it is important to ensure a complete characterization of extractables in order to appropriately assess risk from your SUS components.

Unknowns are unacceptable.

Make sure you identify all compounds, a large number or quantity of unidentified compounds is not a complete characterization of the material tested and makes it difficult to completely assess overall risk. Unknowns are unacceptable and are presumed to be carcinogenic/genotoxic unless you can demonstrate otherwise.


WuXi AppTec’s Approach

WuXi AppTec’s Chemistry Team, located in St. Paul, Minnesota, is dedicated to the chemical analysis of medical materials – conducting thousands of studies with complete characterization and virtually no unknowns.

Our team of experts will work with you to understand your product, process and goals.

The risk for each SUS will be determined and a program will be designed to appropriately challenge your SUS and provide complete characterization so that risk can be assessed.


Complete characterization

Characterization typically includes four analytical methods. Additional methods of analysis will be used when applicable.


Identifying unknowns

It starts with understanding the materials in your SUS with a comprehensive materials list. Then mass accurate data must be collected. These two steps should achieve identifications of nearly all – if not all –compounds found. For the compounds that cannot be identified, it takes time to search and match through databases and public literature and sound scientific thought, but complete characterization is possible and it is the expectation of regulatory bodies.