A meeting of Southern Research’s Institutional Biosafety Committee convened on Thursday, 09 Oct 2025, in Birmingham, Alabama 35205.
The following participants were present:
Participant Voting Status
Kayton Cherry, Voting
Lamar Jones, Voting
Steven Orr, Voting
La’Wanda Parker, Voting
James Toomey, Voting
Carson Sakamoto, Alternate
Christina Humphries, Ex-Officio
Shahab Fakhari, Visitor
Brooke Warren, Visitor
1. Review and Approval of Meeting Agenda
The Chairperson called the meeting to order. The Chairperson asked the committee to
review the agenda. Changes were made to the agenda. A motion was made to approve. A
second was made and by voice vote the agenda was approved with changes.
2. Review and Approval of Previous Meeting Minutes
• 11 Sept 2025 – A motion was made to approve. A second was made, and by voice
vote the minutes were approved.
3. New Business
• BSO Notes/OSP Reportable Incidents Report – No incidents to report.
4. Review and Approval of BPRs and Amendments
R25-09-018NS
Title: Evaluation of Intrathecal (IT) Delivery of AAV9-GFP vector to CNS and Brain,
Maintenance of Catheter Patency, and Implications of IT Dosing in Cannulated
Verses Direct IT dosing in Sprague Dawley Rats
RS: Shahab Fakhari
IBC reviewed, comments and contingencies were received. A motion was made to approve
with changes, a second was made, and by voice vote the BPR was approved.
• Agent Name: AAV9-GFP or AAV9-Luc and aCSF
• Agent Characteristics: produces GFP fluorescence and luciferase bioluminescence (as
applicable)
• Containment Conditions: A/BSL-2INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 2 of 3
• Sources of the Inserted DNA Sequences: GFP reporter (Aequorea victoria); typical
AAV2 ITR backbone with AAV9 capsid.
• Foreign Gene Expression: GFP
• Protein Expressed: N/A
• Applicable Section(s) of the NIH Guidelines: N/A
• Types of Manipulations Planned: AAV9 reporter vectors, will be administered
intrathecal (IT) while comparing outcomes in catheterized versus non-catheterized
animals and establishing catheter-maintenance procedures. Animals will receive either
AAV9-GFP or AAV9-Luciferase or aCSF controls.
Contingency 1: Please check Coverage+ NPD in section 5.3i for ABSL-1&2 CCP. This is
used to mop ABSL-2 necropsy labs.
Response: Corrected
Contingency 2: For section 5.8b, if histo is not directed and this is strictly a gross evaluation
with no tissue collection, this should have Unfixed animal tissues checked and fixed tissues
should be unchecked.
Response: Tissues to be collected and fixed in case further IF-IHC evaluation is needed.
Contingency 3: Check Carcasses in section 5.14b.
Response: Corrected
Contingency 4: Both yes and no are checked for 6.3d.
Response: Corrected
R24-03-007NS A6
Title: Core Non-Infectious HTS Assays
RS: Miranda Nebane
BPRG was administratively reviewed.
• Agent Name: Purified Human Ero1α protein (hEro1α) and Purified Human PDI protein
(hPDI)
• Agent Characteristics: Recombinant proteins, virus-free
• Containment Conditions: BSL-1
• Sources of the Inserted DNA Sequences: Ero1α – Homo sapiens; PDI – Homo
sapiens – provided by the client
• Foreign Gene Expression: N/A
• Protein Expressed: hEro1α and hPDI
• Applicable Section(s) of the NIH Guidelines: Section III-D-2
• Types of Manipulations Planned: HTS team will perform the Amplex Red/hEro1α
catalytic assay; purified hyperactive Ero1α, horseradish peroxidase (HRP), and Amplex
Red will be combined with purified hPDI and library compounds in a microtiter plate, and
fluorescence intensity measured following a predetermined incubation period.
Contingency 1: Section 4.3, change future tense verbs to past tense
Response: Corrected
Contingency 2: Section 4.3, remove “5.5” from list of sections affectedINSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 3 of 3
Response: Corrected
Contingency 3: Section 5.6. For the question “If this is a viral delivery vector, is the vector
replication defective?” neither Yes nor No should be checked.
Response: No was unchecked and a “Not Applicable” option was added
Contingency 4: Section 5.10. The question “Will plant or animal cells be exposed to the
recombinant DNA/RNA?” should be answered No.
Response: Corrected
5. Next Meeting
The next Institutional Biosafety Committee meeting is scheduled for Thursday,
13 November 2025 at 11:15am in Birmingham.
6. Adjourn