General information

Announcements(0)

Overview

Manual for Online Meeting

Participant Registration

Abstract Submission (Oral/Poster Presentation)

General information 2

Abstract Submission (Late-Breaking Session)

Program

Sessions

Search presentations

pharm141_en.png

Change account information such as the email address and password on the account setting screen common to Confit.

Login required to view

Password required to view

Presentation Information

Session Details

A password that applicants have been notified of is required to view abstracts.<br>If you are a participant and need to confirm the password, please contact us by e-mail about which annual meeting you would like to know the password for to view abstracts.<br>We will reply after confirming that you were a participant.<br>Thank you for your understanding.

To browse or post comments, you must log in.

You cannot post comments as it is outside the comment posting period.

This comment has been deleted. You cannot reply to this comment.

Program Type

Profile management

Announcements

Bookmark

Download PDF for print

Timetable

Characterization of simian endogenous retrovirus in the Vero cell genome

Many of “biologics” such as antibody drugs, vaccines, and gene/cell therapy products are made with/out of human or animal-derived cells. In addition, in the production process of these biologics, various kinds of human/animal-derived ancillary materials are often used in their production. Appropriate quality assessment should be required for these cell substrates and ancillary materials. Especially, virus safety should be ensured based on scientific evidence. It is important not only to take measures to prevent contamination of infectious viral particles but also to evaluate the safety/activity of endogenous viruses in cell-substrates. In recent years, with the emergence of novel types of therapeutics or innovative manufacturing technologies, the use of new kinds of cell substrates or ancillary materials has been increased. Nevertheless, they have not been well evaluated for virus safety. Therefore, an international collaborative platform has been provided to discuss the usefulness of new methods enabling us to detect even novel or unexpected viruses. In this session, we are going to cover various topics on virus safety for biologics: genome science of cell-substrates, regulatory trends, etc., and also would like to discuss a new trend of virus safety testing.

New trends in ensuring virus safety in biologics

The 141st Annual Meeting of the Pharmaceutical Society of Japan (Hiroshima)

Presentation Information

[S19-1]Characterization of simian endogenous retrovirus in the Vero cell genome

Password required to view