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Avis adoptés et consultations antérieures sur des demandes d’autorisation

Avis adoptés et consultations antérieures sur des demandes d’autorisation

 

This page provides further information on the applications for authorisation or review reports, which have undergone consultation. The applications for authorisation are in the opinion development phase until the final opinions of the Committees for Risk Assessment and Socio-economic Analysis have been adopted and sent to the European Commission. The European Commission's decision-making process can be followed through the comitology register, where further information is published about the REACH Committee's past and upcoming meetings.

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Substance Details

Name
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated
EC Number
-
CAS Number
-
Entry Nr in Annex XIV
42
Use name
4-tert-Octylphenol ethoxylate is used as a lysing agent for the permeabilization of the host cell membrane to release adenovirus particles used for the manufacture of vaccines. Its use allows the selective elimination of enveloped adventitious viruses and is compatible with the chemicals needed to control the host cell DNA precipitation in the next process step.
Broad information on use applied for (conditions of use and function)

The substance (OPnEO) intervenes at one stage of a 10 step production process to ensure: lysis of cells to allow the extraction of specific viral particles, elimination of adventitious viruses and preventing the precipitation of specific viral particles.

OPnEO is the active cell lysis agent (cell lysis in this case is a process whereby a cell membrane is permeated and virus particles are extracted from the cell) in order to produce a number of particular vaccines at Janssen. This primary function of OPnEO is done by permeating the outer cell membranes of the cells but not the membranes around the cell nucleus. The OPnEO makes holes of the desired size in the cell membranes which allow the desirable adenovirus particles to be extracted. The majority of the remainder of the cell content stays inside the cell. Since OPnEO does not permeabilize the nuclear membrane, most host cell DNA (the level of DNA in the vaccine is set in a regulatory requirement) is not released in lysis with OPnEO, which is one of the advantages of the use of OPnEO as the selective lysing agent.

OPnEO has a secondary function, in that its presence eliminates viruses that have a lipidic envelope. This characteristic reduces the chance of a harmful or undesirable virus being present in the vaccine. This function of the OPnEO is a crucial safety measure in the production of the vaccine.
A tertiary and final function of OPnEO is that, being a non-ionic detergent, it can safely interact with the detergent domiphen bromide used during DNA precipitation.
Following a development program, as well as the production of clinical trial materials (up to and including phase 3 trials), the applicants will start commercial production in a closed system with zero emissions to the environment.

Annual tonnage used: 0.27 (tonnes/year)

Review period requested: 15 years

Use applied for number in application for authorisation
1
Broad information on use applied for (Use descriptor system)
Sector of end use (SU): 9
Environmental release category (ERC): 4
Process category (PROC): 1, 8b, 9, 15
Product category (PC): 29
Article category related to subsequent service life (AC): n/a
Technical Function: Processing aid in vaccine production
Summary table of RMMs and OCs (non confidential)
Section 9 and 10 of the CSR (original and updated, if available) (non confidential)
Analysis of Alternatives (non confidential report)
Substitution Plan (non confidential summary)
Socio-Economic Analysis (non confidential report)
Joint Analysis of Alternatives and Socio-Economic Analysis (non confidential report)
Explanatory note
Additional information
ID
0169-01
Applicant(s)
Janssen Vaccines & Prevention BV
Janssen Biologics B.V.
Application type
Initial
Status
Opinions adopted
Other consultations on the same/ similar use
Comments submitted to date
No comments received
Response to comments by applicant
Responses to RAC and SEAC requests by Applicant(s) (non confidential)
Compiled RAC and SEAC opinions
Minority positions
Adopted commission decision (OJ summary)
Authorisation decision

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