SynCo and CBLI formed a steering committee, which agreed on weekly goals and follow-up action items despite only meeting face-to-face every six weeks.
During development, CBLI had used an ion-exchange column as its first purification step, but the resins used were not suitable for use in cGMP production as these were not available at a quality compatible with cGMP production.
At all stages, SynCo ensured that the testing of CBLI product was treated as an absolute priority in order to cut testing times to an absolute minimum.
However, as Ed said earlier, "The diversity of thinking made for excellent problem solving, especially when the times got tough," and this helped both CBLI and SynCo prove that, in certain circumstances--24 into 12 does go, but only just?
Analytical methods were also transferred from CBLI to SynCo where they were qualified so that they could be used for batch release and stability studies.
Ed joined CBLI after SynCo had been selected as CBLI's development partner, but was more than comfortable with the decision because he knew of SynCo and its track record for high quality and meeting tight deadlines for process development and cGMP production.
Validation studies comparing CBLI with tibia lead provide evidence that CBLI is an estimate of cumulative lead dose.
3 [micro]g/g, which corresponds approximately to an increased CBLI of 400 [micro]g-years/dL.
A potential limitation with interpreting CBLI and health effects is that many of the studies that have attempted to use CBLI have involved worker cohorts that had much higher BLLs in the past, but lower levels at the time data were collected and the cumulative lead dose (i.
Another point to consider when interpreting CBLI is that some of tibia lead (and blood lead) may derive from higher past environmental (nonwork) exposures.
Thus, in this mini-monograph, we believe that epidemiologic studies that measured either tibia lead or CBLI have adequately estimated cumulative dose.