We are happy to announce Nelson Labs will be exhibiting in booth A86 at the 2021 Pharmapack tradeshow, in Paris, France October 13-14, 2021.
Our experts, Pieter Van Wouwe and Ward D’Autry will both deliver a presentation at this event:
Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Presenter: Pieter Van Wouwe PhD, E&L Expert
Tuesday, 28 September 2021, available at 00:01 am CET/CEST (Cent Europe Summer, GMT+2)
In the past decades, scrutiny has changed in the way EMEA or FDA regulators look at Extractables & Leachables data. Requirements gradually increased, not backed up with any official document (Guidance, guideline…) which left the Pharmaceutical Industry in the dark. Second guessing of what the current position and requirements of regulators are to support a submission became the normal.
In this presentation, the key factors of success of any given E&L project will be highlighted. Crucial is to understand what regulators really want and to align the design space of an E&L study to their expectations.
Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of Extractables and Leachables testing and state-of –the art technology. Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.
Only through successful partnering between drug product vendors, material suppliers and the CRO performing the test, a true mitigation of the risk related to packing can be established.
Where N-Nitrosamine Assessments for Drug Products meet Extractable / Leachable Qualifications for Pharmaceutical Primary Packaging
Presenter: Ward D’Autry PhD, Senior E&L expert
Wednesday, 29 September 2021, available at 00:01 am CET/CEST (Cent Europe Summer, GMT+2)
Recently there have been a number of drug product recalls due to the unexpected presence of N-Nitrosamines. While in most of those cases, N-Nitrosamine formation occurred at the level of the drug substance synthesis and stability, it is well known and documented that some materials, used in primary packaging can also be a source for N-Nitrosamine contamination of the packaged drug product (e.g. older grade elastomers and nitrocellulose laminated blister foils). The unanswered question is: do we know everything about the materials of construction of a container closure system and their ability to generate N-Nitrosamines? When looking at the formation mechanism of N-Nitrosamines, it are secondary amines (and potentially tertiary amines) that are a precursor to N-Nitrosamine formation, together with a nitrosating agent (such as e.g. nitrite/nitrous acid). When evaluating the extraction profile of materials of construction, it is clear that secondary amines are often encountered as an extractable being present in the material. Should this raise a “red flag” for those materials in an N-Nitrosamine risk mitigation strategy, as one precursor for N-Nitrosamine formation is obviously present in the material? And what could be the consequence of these findings, both for the design of extractable and leachable studies, as well as in the assessment of the E/L-results? This presentation will give more insights on how an integrated approach for both the E/L-qualification as well as the N-Nitrosamine risk evaluation for a pharmaceutical container closure system could look like.
Find more information about this event at: www.pharmapackeurope.com