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Adopted opinions and previous consultations on applications for authorisation

Adopted opinions and previous consultations on applications for authorisation

 

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
Industrial use of the substance as a surfactant in the purification of the biopharmaceutical drug Orencia, used for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis and Adult Psoriatic Arthritis
Broad information on use applied for (conditions of use and function)

4-tert-OPnEO is used in the manufacturing process for the Applicant’s Biological Drug Substance (BDS) abatacept. 4-tert-OPnEO is used for viral inactivation to ensure safety of the final drug substance as per regulatory guidelines.

4-tert-OPnEO is an established and effective viral inactivation agent. It is particularly effective against enveloped viruses which are difficult to inactivate. It is used by the Applicant as it is not denaturing to the protein (drug substance) being purified.

The Applicant's downstream process involves incubating abatacept with 4-tert-OPnEO at a defined temperature and time in accordance with the designed process parameters. The detergent is removed in the subsequent chromatography step while the product is purified further to its final purified state. 4-tert-OPnEO waste is removed to a dedicated on-site segregated storage container, from where it will be disposed of by incineration by an off-site licensed waste contractor. 4-tert-OPnEO is not present in the final product.

The Applicant is progressing R&D studies to find an alternative to 4-tert-OPnEO that is an effective viral inactivation agent that does not impact the quality of abatacept.

Any potential alternative (substance or technique) must meet the following criteria:

  • Meet the regulatory expectation for viral inactivation within the Applicant’s process including orthogonal approach to inactivation
  • Maintain the quality of the purified protein, in particular minimise the level of aggregation and maintain these levels within the required regulatory specification limits.
  • Have reduced adverse impact on human health and the environment as compared to 4-tert-OPnEO
  • Must be commercially available, with no Intellectual Property (IP) constraints and must be economically feasible.

Annual tonnage used: 1-3 tonnes/yr

Review period requested: 12 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): 3, 5, 8b, 9, 15
Product category (PC): 21, 29
Article category related to subsequent service life (AC): n/a
Technical Function: Surfactant
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
0158-01
Applicant(s)
Swords Laboratories
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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