Leachables Testing Methods & Best Practices

Author: Nick Hutchinson

BPOG’s Best Practice Guide

The biopharmaceutical industry is increasingly using Single-use systems (SUS) for the manufacturing of medicines. Furthermore, companies are applying the technology in applications that are more critical to patient safety. Methods for assessing risks associated with using SUS in bioprocessing need to be developed.

Miriam Monge, Marketing Director for Integrated Solutions at Sartorius Stedim Biotech moderated a session at the BioProcess International Conference & Exhibition, 2016 in which representatives from the BioPhorum Operations Group (BPOG) discussed best practices for leachables testing when implementing SUS. During her introduction, Monge highlighted the need for the various stakeholder in the industry to work together to find consensus on testing methods.

Not a standards body

Ping Wang (Janssen) and Seamus O’Connor (Regeneron) spoke on behalf of BPOG and described BPOG’s Leachable Best Practice Testing Guide for Industry. BPOG is a global collaboration of commercially active biopharmaceutical companies that started in 2008 and currently has 33 members. It is not a standards body nor represents suppliers, but collaborates with these organizations and other bodies to realise change within the industry.

O’Connor stated that leachables testing is the responsibility of the SUS end-user and not the supplier. BPOG presented a practical and adaptable approach for assessing SUS for the risk they present to biopharmaceutical manufacturing processes. Their objective is to help end-users design studies to assess SUS components using appropriate analytical methodologies for the detection of potential leachable compounds. BPOG intend the guideline to be flexible and to be adapted by the individual needs of biotech companies. It is aimed at end-users with experience that want to compare their approach with others in the industry and those that are still developing their approach.

The guide contains three sections. The first section provides advice on the use of risk assessments to identify leachables that may warrant additional investigation. The guide provides a comprehensive list of recommended information on which to base a risk assessment.  The second section of the guide recommends an approach to process-relevant studies that support a full range of manufacturing process conditions. The final section describes analytical techniques that can be used to support firms with their analytical method development.

The presenters described a Leaching Propensity Model and explained how leachable risks increase with distance along the process stream with the highest risks being beyond the final purification step. Leaching propensity increases with exposure duration, temperature, surface area, solvent volume and power. The BPOG team explained how these different factors can be weighted during the risk assessment.

Need for further alignment on leachables testing

Finally, the BPOG team presented the results of a survey comparing current industry practice with their proposal and other approaches that have been recommended. Unsurprisingly perhaps the survey showed that current industry practice is most similar to the BPOG guidelines. However, the presenters acknowledged that current industry practice was still not the same as the guidelines they have recommended.

Despite significant progress, more can still be done to align the industry on a best practice for leachables testing.

Further information is available from http://biophorum.com/

About the author: Nick Hutchinson is a Technical Content Marketing Manager at Sartorius Stedim Biotech.

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