Q. Please briefly describe your background with Extractables & Leachables and your current role at Janssen Biologics.
I work as a Senior Process Validation Engineer in a process validation support role in the Technical Operations group in Janssen Biologics Ireland (based in Ringaskiddy in county Cork). Part of my role is concerned with evaluating potential extractables and leachables risks arising from the use of polymeric materials in manufacturing operations. This risk is based on the use of the polymeric material in each process and the potential risk to patient that arises as a result.
Q. Having worked across a number of roles in the industry and gained a wide range of expertise, how do you think the situation has changed in R&D and manufacturing over the last 25 years?
The key changes that I see are related to the difficulty in discovery of new molecular entities for treatment if various health conditions. As the rate discovery of the number of new therapeutic molecules has decreased, the cost of bring new medicines to market has risen significantly, presenting greater financial challenges to research lead pharmaceutical companies. Another change has been the adoption of single use systems (SUS), or disposable technologies, particularly in the biopharmaceutical sector. This has increased focus on the extractables and leachables challenges for pharmaceutical manufacturers.
Q. How long have you been involved with The BioPhorum Operations Group for?
While Janssen is a long-time member of BioPhorum Operations Group (BPOG), I am a relatively new member - I joined in February 2014. BPOG is a global collaboration of biopharmaceutical manufacturers with a number of active work streams, one of which is the Extractables and Leachables Working Group.
Q. Can you detail what their main aims are in relation to Extractables and Leachables testing?
The BPOG main aim in respect of Extractables Leachables testing is to generate an industry-wide approach to extractables and leachables testing. This is summarized in our Extractables protocol which is currently in publication via a technical paper in Pharmaceutical Engineering published by the International Society for Pharmaceutical Engineering (ISPE).
Q. Last year BPOG representative Gerry McAuley presented with Jason Creasey of GSK, can you give us a sneak preview of what updates this year's presentation will cover?
The key update from last year's presentation is that the extractable protocol has been finalized by the BPOG working group - the details of this will be presented at this year's conference.
Q. Finally, what are you looking forward to most about Extractables and Leachables Europe 2014?
I am looking forward to presenting the finalized protocol requirements to the conference attendees. This should serve both the needs of both the BPOG members along with the manufacturers of single use systems in terms of having a standard approach that benefits both manufacturers of SUS and BPOG as the need for SUS manufacturers to meet different extractables testing for each customer should be largely eliminated.