Ryoncil: ODAC/FDA Meeting Discussion, page-257

Geraldine Storton (From MSB) - Third Speaker

Outlined method of selecting donors, method of manufacture, and consistency and quality.

“The donors must be prescreened and blood testing and undertaken up to one week prior to donation to check for a full infectious disease profile.”

“In addition to meeting all of the requirements for good tissue practice we have added additional criteria to donors such as body mass index, age, and bone marrow cell count.”

“The screening process works to prevent introduction of possible communicable diseases and the additional measure are included to reduce variability in the attributes of the cells such as the [ Indiscernible ] capacity leading to more consistency in the yields of the manufacturing process.”

“Each donor cell bank is derived from a single donor which following culture expansion generates multiple containers of donor cell bank”

“The second stage involves the continued production of drug substance and formulation of the final drug product.”

“The product is cryopreserved and stored below negative 185 degrees Celsius and liquid nitrogen.”

“One donation of bone marrowcan manufacture enough drug product to treat more than 400 patients”

CONSISTENCY: Throughout manufacturing there are a number of them process controls to monitor the quality of the cell and the manufacturing environment to ensure that the process is being executed consistently.

Cell count and viability are routinely monitored to assist consistency of cell growth throughout the process.

Attributes such as stability are monitored to ensure the process maintains an effective environment throughout

In addition quality control release testing is performed on the donor cell bank and the final drug product.

“As the drug substance is immediately processed that test on the truck substance are focused on them process sterility to ensure the subject environment has been maintained.”