NP Ballot: ISO/NP 16921-4 Biotechnology — Gene delivery systems — Part 4: General Considerations for Characterization of the Capsid Protein Particle Population in AAV Products

By 02-Sept-2026, US TAG members are invited to:

Vote: Each US TAG member organization has a single vote (in cases of multiple votes from a single organization, the designated voter will be prioritized).

Provide Comments: Comments are welcome from all individual US TAG experts-please add them in the ISO Portal in OSD using the "link to document" in the email.

Ref: Ballot file links may be found in the table e-mailed to you with the ballot announcement.

Question Title

1. What is your name?

Question Title

2. What is your affiliation?

Question Title

3. What is your recommended response for this NP ballot and its addition to the ISO/TC276 work programme?

Approve

Not approve (comments required)

Abstain

No recommendation

Question Title

4. Please select from the following options:

Draft document can be registered as a Working Draft (WD - stage 20.00)

Draft document can be registered as a Committee Draft (CD - stage 30.00)

Draft document can be registered as a Draft International Standard (DIS - stage 40.00)

Question Title

5. In case of disapproval, do you believe that further study and consultations are needed first among committee members on this proposal as a preliminary work item before this proposal can be formally accepted?

Yes

Question Title

6. Do you know of any Standard(s), regulation(s), and other relevant documentation existing in our country? Do you have any comments concerning their application or consequences for global relevance? Do you know of any copyright information on these documents?

Yes

Question Title

7. If so, provide information here.

Question Title

8. Should the US be committed to participating on the International Drafting Team (IDT) in the development of the project? If yes, please enter the name and email of one or more nominees as US expert to the international drafting team (you may submit your own name):

Yes

Enter name and email of nominated expert for project.

Question Title

9. If this proposal is approved, would you like to be considered for the US lead or be on the US expert team?

Considered for US lead

Participate on the US expert team

No active participation at this time

NP Ballot: ISO/NP 16921-4 Biotechnology — Gene delivery systems — Part 4: General Considerations for Characterization of the Capsid Protein Particle Population in AAV Products

By 02-Sept-2026, US TAG members are invited to:

Question Title

* 1. What is your name?

Question Title

* 2. What is your affiliation?

Question Title

* 3. What is your recommended response for this NP ballot and its addition to the ISO/TC276 work programme?

Question Title

* 4. Please select from the following options:

Question Title

* 5. In case of disapproval, do you believe that further study and consultations are needed first among committee members on this proposal as a preliminary work item before this proposal can be formally accepted?

Question Title

* 6. Do you know of any Standard(s), regulation(s), and other relevant documentation existing in our country? Do you have any comments concerning their application or consequences for global relevance? Do you know of any copyright information on these documents?

Question Title

* 7. If so, provide information here.

Question Title

* 8. Should the US be committed to participating on the International Drafting Team (IDT) in the development of the project? If yes, please enter the name and email of one or more nominees as US expert to the international drafting team (you may submit your own name):

Question Title

* 9. If this proposal is approved, would you like to be considered for the US lead or be on the US expert team?

1. What is your name?

2. What is your affiliation?

3. What is your recommended response for this NP ballot and its addition to the ISO/TC276 work programme?

4. Please select from the following options:

5. In case of disapproval, do you believe that further study and consultations are needed first among committee members on this proposal as a preliminary work item before this proposal can be formally accepted?

6. Do you know of any Standard(s), regulation(s), and other relevant documentation existing in our country? Do you have any comments concerning their application or consequences for global relevance? Do you know of any copyright information on these documents?

7. If so, provide information here.

8. Should the US be committed to participating on the International Drafting Team (IDT) in the development of the project? If yes, please enter the name and email of one or more nominees as US expert to the international drafting team (you may submit your own name):

9. If this proposal is approved, would you like to be considered for the US lead or be on the US expert team?