A3P

Connexion

logo lonza hd

ATELIER 3
Low Endotoxin Recovery – Where does the industry stand?

Low Endotoxin Recovery (LER) also known as Low Lipopolysaccharide Recovery (LLR) has been a controversial topic circulating throughout the endotoxin testing community for nearly three years. There is some evidence to show that LER is an irreversible masking effect brought about the combination of certain surfactants (Polysorbate) and chelators (Citrate, Phosphate) that are used in over 70% of drug formulations, particularly biologics.
Although some have suggested “demasking” as a means to overcome LER and comply with the US Food and Drug Administration’s request for hold-time studies in Biologics License Applications (BLA), many are still trying to understand whether these processes are actually necessary. The argument remains that the LER phenomenon is something that has actually been around for years, and does not pose a public health risk. While others still question whether there is a missing link between the unrecoverable endotoxin and its potential to become active in the human body.
Like most endotoxin test manufacturers, Lonza has also been following the LER movement and is working diligently to find a solution to assist drug manufacturers in their product investigations. This presentation will walk through the current status of LER, from both the user and regulatory perspective. We will give insight as to what regulators are looking to see in the BLA regarding hold-time studies, as well as provide insight into what the industry is doing to “unmask” the endotoxin that may be lurking in drug products.

LES HÔTELS À PROXIMITÉ

Mercure Tours Centre ***

29, rue Edouard Vaillant
Tel. 02 47 60 40 60


Le Grand Hôtel ***

9, place du Maréchal Leclerc

    Offre Rencontres A3P Microbiologie
    Single bb classique 74.00 euros
    Single bb confort 84.00 euros
    Single bb supérieure 99.00 euros
    Taxe de séjour : 1.10 euros


Hôtel Ibis Tours Centre Gare ***

1, rue Maurice Genest (ex rue Georges Claude)
Tel. 02 47 70 35 35


Adagio Acces ***

41, rue Edouard Vaillant
Tel. 02 47 47 40 00