We spoke to Sara Ulsten, R&D Section Manager at GE Healthcare, ahead of her participation at E&L Europe 2019 to get an exclusive preview of what she'll be talking about, the main challenges she faces day-to-day in this industry, revolutionary E&L research and more.
Your presentation will discuss “BPOG E&L SUS – the final chapter“ can you give us a sneak peak of what delegates will hear?
BioPhorum operations group published an extractables protocol in 2014. Three years after the publication, a shared workstream between end users and supply partners was established. Aim of the workstream is seeking to facilitate a standardized solution for extractables information exchange between multiple companies within the bioprocessing supply chain. In addition, the protocol from 2014 is under review as part of this workstream. The presentation will present the outcome of the workstream.
Why did you choose to tackle this topic?
The BPOG extractables protocol has a big impact in the bioprocess industry, and tackling obstacles related to the protocol will create benefits to the industry. It is important that end-users and supply partners have a shared vision.
What are the main challenges in your day-to-day work relating to E&L?
As manager of an extractables lab I would say identification of compounds to avoid reporting a compound as unknown. It requires good databases and knowledgeable people and is a skill that is developed over time. I am very fortunate to have a talented team!
Where is the extractable and leachable field headed in coming years and what’s revolutionising extractable and leachable research?
In the bioprocess field, the extractables conversation still revolves around standardization of test conditions. The draft USP chapter <665> was closed for comments earlier this spring and the industry is waiting for it to be finalized, which will have a big impact.
What are the major challenges that the extractable and leachable industry is facing?
The increased uptake of single-use components has increased the amount of polymeric parts in biopharmaceutical manufacturing. This brings along an increased amount of components to test for E&L, and one challenge for the industry is how to accommodate this increased test demand.
What are you most looking forward to hearing about at E&L Europe conference? I’m looking forward to hearing about toxicity assessment and effects of E&Ls on the safety and efficacy of biopharmaceuticals. And of course, the topic of characterisation of unknowns is always interesting!
What is one thing you hope to learn or discuss with your peers at this E&L conference?
I’m hoping to have discussions on the regulatory landscape, to get insights on different strategies implemented to fulfil regulatory requirements for E&L studies.
Why do you feel it’s important for companies to attend E&L Europe 2019?
The conference covers many aspects of E&L and is a good opportunity for networking and keeping informed on the most up-to-date developments in the E&L field.
Sara will be presenting as part of the Regulatory Landscape, Requirements & Strategies for E&L Studies session this November, alongside other speakers including U.S FDA, Eakins & Associates, Sanofi Pasteur, Novo Nordisk & more.
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