MEETING MINUTES
A meeting of Southern Research’s Institutional Biosafety Committee convened on Thursday, 12 JUN 2025, in Birmingham, Alabama 35205.
| The following participants were present: Birmingham Site | |
| Participant | Voting Status |
| Steven Orr | Voting |
| James Toomey | Voting |
| La’Wanda Parker | Voting |
| Mark Jackson | Voting |
| Philip Garst | Voting |
| Kayton Cherry | Voting |
| Christina Zink | Ex-Officio |
| Christina Humphries | Ex-Officio |
| Thorsten Demberg | Guest |
| Joseph Randall | Guest |
approved.
INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 2 of 3
• Agent Name: Humanized IgM antibodies
• Agent Characteristics: The antibody binds to human T-cell receptor and leads to a downregulation of the receptor.
• Containment Conditions: A/BSL-2
• Sources of the Inserted DNA Sequences: N/A
• Foreign Gene Expression: N/A
• Protein Expressed: N/A
• Applicable Section(s) of the NIH Guidelines: Exempt: Section III-F-1
• Types of Manipulations Planned: Primary cells/cell lines will be incubated with each of the selected antibodies and the downregulation of the TCR will be assessed by flow cytometry. Proliferation of the cells will be tested and the cell culture supernatant will be evaluated for released cytokines by multiplex assay.
Contingency #1 – Section 4.2: I would suggested bloodborne pathogen training at minimum since blood collection and necropsy is involved.
Response: This has been added.
R25-05-012NS
Title: A 4-week Toxicity Study of TA01 in Sprague-Dawley Rats with a 4-week Recovery Period (16631.01)
RS: Joseph Randall
IBC reviewed, comments and contingencies were received. A motion was made to approve with additions, a second was made, and by voice vote the BPR was approved.
• Agent Name: [REDACTED]
• Agent Characteristics: A specific TGF-β1/3 cytokine inhibitor with efficacy inhibiting adipose tissue differentiation in an in-vitro model and inhibiting muscle fatty degeneration in an in-vivo mouse model of induced muscle injury.
• Containment Conditions: A/BSL-2
• Sources of the Inserted DNA Sequences: Sponsor-provided; recombinant human fusion protein of the extracellular domain of the type II TGF beta receptor fused to a human IgG1Fc domain.
• Foreign Gene Expression: N/A
• Protein Expressed: N/A
• Applicable Section(s) of the NIH Guidelines: Sections III-D-4, III-E-1
• Types of Manipulations Planned: To be administered to rats; serum samples will be analyzed for anti-drug antibody levels and blood samples will be used in TK ligand binding assays.
Contingency #1: For Section 8.3, it states list other hazardous chemicals that are not carcinogens, etc. 10% neutral buffered formalin was already listed above in Section 8.2. I suggest listing your disinfectants in this section.
Response: I have updated the list of hazardous chemicals to include the following disinfectants:
• PREempt RTU (Hydrogen peroxide)
• Lysol IC 0.39-1.0%
INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 3 of 3
• Bleach (1:9 dilution; ~0.5% sodium hypochlorite)
• Vesta-Syde NPD 0.8%
Comment: I have removed the abstract reference in Section 9.0 since this specifically identifies the client by name. In addition, the name of the test article was changed from [REDACTED] to TA01 for confidentiality reasons. These changes have been incorporated into BPR R25-05-012NS Draft 3.
5. Next Meeting
The next Institutional Biosafety Committee meeting is scheduled for Thursday, 10 JUL 2025 at 11:15 in Birmingham.
6. Adjourn