Despite several techniques can be used to detect pyrogens and endotoxins, the historical in-vivo method, the Rabbit Pyrogen Test (RPT) and the in-vitro Limulus Amebocyte test (LAL) also known as Bacterial Endotoxins Test (BET) are still the most commonly used methods.
This has slowly started to change after the Monocyte Activation Test (MAT) was developed and recognized as an alternative method to RPT and included into Ph. Eur. as compendial method in 2010 and USP as an alternative method in 2012.
Furthermore, MAT is mentioned as a pyrogen test in guidelines for pyrogen detection in medical devices, namely ISO/TR 21582:2021 – Pyrogenicity “Principle and method for pyrogen testing of medical devices”.Even though lack of harmonization between Pharmacopoeias is one of the main hurdles, the recent European Pharmacopoeia Commission pyrogenicity strategy has traced the path that will lead to the complete removal of the RPT from Eur. Ph. by July 2026 and the publication of a specific pyrogenicity general chapter.This webinar aims to give an insight about the technical aspects of MAT and its regulatory framework, discussing current challenges such as material mediated pyrogenicity.
Pyrogens, alternative methods: Monocyte activation test
FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.
DATE: April 11, 2024 | 3.00 PM - 4.00 PM CET
OFFICIAL LANGUAGE: English
SUBMISSION LINK: https://attendee.gotowebinar.com/register/975951147912362332
ATTENDEES CAPACITY: 500 delegates
The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.
Luca Benedan work as a consultant in Eurofins Regulatory & Consultancy services Italy in BioPharma division where his focus is mainly related to biological products and advanced therapies medicinal products (ATMPs). He is a biotechnologist by education and holds a master degree in Medical Biotechnology&Molecular Medicine.Before joining ERCSI he was Project Leader for the Biotech&Micro lab in the biologics division in Eurofins BPT Italy, leading the biosafety area, which included in vitro endotoxins & pyrogens testing.
During that period, he gained extensive knowledge of MAT, conducting and supervising several MAT activities.