23 March 2022: Presentation (Production in Scotland/Northern Ireland) - C
Counsel restarted with a table which compares the F8/F9 development pathways for the two types of factor concentrates. The key series of events to produce safer (from viruses) products centres on the pivotal year 1982. By 1983, viral inactivation was apparently the only game in town, but what was the best method which balanced cost and obtaining useable quantities of material? Then AIDS landed.
There was evidence of a "panic recourse to cryo" due in part to Sunday newspaper scare stories. The possibility of concentrates being abandoned was seen as a danger. It certainly concentrated the minds of those who were leading on product safety. Pasteurisation was the initial preferred option for inactivation.
After a conference in late 1983, it looks like a dry heat treatment process became the safety strategy of choice. The development period for that was thought to be two years.
January 1984 sees Prof Ludlum report adverse reactions from one of his patients.
A Scottish product rolled out of the lab in 1985. In the development period, how was the efficacy of the in-development product tested? Was that where we came into the picture? The policy of dedicated batches for specified patients came into being in 1984. Coincidence?
The 68° heat treatment process caught the HTLV3, but not the viral Hepatitis. Then 80° appeared to be high enough. And so Z8 becomes ready for clinical trial. At the same time, there was the concerning possibility of a potential liability issue if there was an adverse event. Ludlum is a loud voice in this debate. By 1987 the SHHD seems to have come up with a solution which satisfied clinicians. It would possibly involve animal studies. (Were they barking up the wrong tree with that, woof?)
Next ... pool sizes. (Olympic or hot tub?)
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