Ahead of next month's Extractables & Leachables Europe 2021, we recently spoke to expert speaker, Christopher T. Houston of Bausch + Lomb.
Our exclusive interview covered a sneak peek of his presentation on 'Challenges and lessons learned in the study of extractables and leachables in opthalmic drug products', as well as why this topic is so important, the major challenges faced by E&L professionals at the moment, and more.
Take a look below now to find out what was said...
Christopher, please could you tell us more about your upcoming presentation at E&L Europe 2021?
E&L for ophthalmic drug products has always struck me as a fringe specialty. Oddly enough, we focus more on those components of the packaging system that do not directly contact the product than on those that do. This results from the specific properties of common ophthalmic packaging systems. To the uninitiated, this usually comes as a surprise.
My presentation was inspired by a recent regulatory comment regarding a leachable (migrant) that we observed from a secondary packaging component. To paraphrase, “This is very unusual. Are you certain?” In fact, this scenario is not unusual in ophthalmology at all, but awareness seems to be limited. The goal of this presentation is to summarize 20 years of learnings around ophthalmic E&L and discuss those items that are strategically important in ophthalmic E&L studies. We will also devote some time to regulatory expectations, the PQRI, and where we see expectations around ophthalmic drug products evolving.
We had a lot of attendees asking to hear case studies from the ophthalmic field – why do you think it is getting so much interest now?
I think the interest stems from an ambiguity surrounding ophthalmic drug product E&L requirements. Our strategic focus with these drug products is different from most routes of administration because we focus on non-contact packaging components. Health authority expectations are unclear in the ophthalmic space and most guidelines do not mention ophthalmic drug products at all. There has been a long-standing, but unwritten, set of expectations from the US-FDA that follows a different logic than the SCT/AET approach created by PQRI that has been adopted for most other dosage forms. Efforts to standardize threshold approaches for ophthalmic drug products have been challenging. We’ll talk about this. Against this backdrop, there has been a rise in contract laboratories that specialize in E&L. In speaking with some of these labs, it is clear that the E&L needs of ophthalmic drug products remain foreign and confusing to many E&L practitioners. In years past, there were few companies doing ophthalmic development and most of them managed their E&L studies internally. I suspect that the increased interest in ophthalmic case studies arises from an increased number of laboratories being asked to solve E&L problems in the ophthalmic space.
What do you see as the major challenges that E&L professionals in general are facing?
In the microcosm of ophthalmology, one of the biggest challenges continues to be the lack of global harmonization around regulatory expectations. Occasionally, we find ourselves caught between conflicting expectations between different regions of the world. Speaking more broadly, I think the subject of chemical characterization for medical devices and combination products is particularly interesting right now given significant revision to ISO 10993-18 and the learning curve that exists for both industry and health authorities alike as we collectively work to implement the guidelines.
What are you most looking forward to hearing about and discussing with your peers at E&L Europe 2021?
As a scientist in the United States, most of my work is decidedly FDA-centric. Opportunities to speak directly with peers in Europe are always welcome. Are they facing different challenges? Do European health authorities have E&L concerns that differ from those of the US FDA? I am also particularly interested in the medical device portion of the program as this is an area that has been evolving particularly rapidly.
Why do you feel it’s important for companies to attend?
As a field, E&L has been in a state of flux for many years and currency is the key to success. In my experience, scientists who are not E&L practitioners often find the field to be daunting or, at the very least, uncomfortable. I believe that the reason for this is that E&L has evolved rapidly, continues to evolve, and cannot simply be distilled into a rote treatment similar to related substances under ICH Q3B. Interactive meetings such as this one immerse us in the context of current thinking in a truly valuable way.