Sampling Protocol

At the 500kg level, the entire lot was distributed into eight, sequentially-numbered drums. We removed two 200g samples from the top, middle and bottom of each drum. For physical testing, we analyzed all samples.  For cell culture and productivity testing, double samples were alternated between top (T), middle (M) and bottom (B) of sequential barrels. At the 90kg level, we placed the entire batch into 1 drum, from which two 200g samples were taken from top, middle and bottom locations. At the 9kg level, we removed samples from only one location due to container size.