A15 - Technical Questions and Answers dtd 11-2-2020.pdf

Technical Q&A’s

CRT AbRc Materials

RFQ 00HCUGDH-2021-49898

Dated: 11/2/2020

Question 1: The storage conditions listed are -80°C. We have typically stored similar materials at -20°C. Would this be acceptable or is -80°C required?

Answer 2: For the AbRc Materials, we have only evaluated stability of the materials at -80°C, so for the reservation and storage of the materials (Task 4), -80°C is required.

Question 2: Regarding the storage conditions (question #3), for short term storage of <

1 month, can the products be stored at freezer temperature until final packaging occurs and then moved to sub-freezer (-80°C)?

Answer 2: Yes, for short term storage, -20°C will suffice, but long-term storage of all materials requires -80°C.

Question 3: Are you able to provide the country of origin for the Abrine-13C,D3 which the

CDC would be providing?

Answer 3: It was synthesized in the United States.

Question 4: Can you clarify the statement “Description of Methods table according to ISO

17034 standards?”

Answer 4: Tasks 1, 2, and 3 for all methods require that all samples are prepared according to

ISO 17034 standards. The samples required are described in the Description of Methods table.

Question 5: What is CDC looking for specifically in the request for a summary of the homogeneity and accuracy data for review? This is on the COAs generated so would that suffice or is the CDC looking for one of the below options?

1) In process results prior to packaging (i.e. an email with a table once each level is tested and

QA reviewed

2) Formal report at end of summary containing all the data and methodologies from the 3 separate task kits

Answer 5: We would be looking for the option (1), where CDC can review the QA results before packaging.