The pharma and biopharma communities have plenty of choice in events. When it comes to extractables and leachables many of the big pharma symposia carry sessions on this hot-topic. However, the Extractables & Leachables USA conference is focused and offers some real advantages to get insight into this field.
Here’s why I’m attending:
It’s a perfect place to get updates from regulatory agencies, industry working groups, and learn about changes and future directions of guidelines or proposed standardized methods.
2. NIBRT E&L Research
The National Institute for Bioprocessing Research and Training (NIBRT), Ireland, has been working with a consortium of seven biopharmaceutical companies on a colossal study of single-use bioprocess bags for extractables and leachables. Jonathan Bones (Principal Investigator, NIBRT) will be presenting this study, with some initial results, that uses the latest technology to screen for unknowns.
3. New Technology for Extractables Testing
The complex nature of extractables demands ever more sophisticated analytical techniques to unambiguously identify and quantify potential leachables. I’m encouraged to see several vendors present their new technology at the event. I’ll be talking about our portfolio that meets the needs of extractables testing; including for the first time at E&L USA, I’ll be presenting data from the new Thermo Scientific™ Q Exactive™ GC Orbitrap™ GC-MS/MS that delivers confident identification and quantification of semi-volatile unknowns.