PS2: ATMP innovations and clinical trials with genetically modified organisms

PS2

Patrick Ginty focused on ‘off-the-shelf’ cell therapies from a scientific and regulatory perspective. He stressed the importance of defining the criteria, namely, cell-based therapies that are manufactured from healthy allogeneic donor with material and stored until ready for patient administration – essentially one donor to multiple recipients with no patient-donor specificity required. Conversely, we then don’t include autologous cell therapies (same donor and recipient) and allogeneic cell therapies which are donor-recipient specific, ie., anything which is Human Leucocyte Antigen-restricted (HLA) to avoid immune reaction.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.

1. REGISTER FOR FREE

Free access to selected content

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account

2. Members login

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Login

3. JOIN TOPRA

Special offer on
TOPRA membership

Join TOPRA today and get membership until the end of 2025 for the exclusive rate of £290.

In addition to unlimited access to Regulatory Rapporteur content, as a TOPRA member you will also be able to enjoy a wide range of benefits including career boosting resources, savings on our events and training, and access to our regional networks and special interest groups.

This offer ends 31 July 2024

Become a member