Positioning of plan requirements for any long term solution directed at economic viability, which includes pricing, is a part of even FDA guidance. MHRA and all regulators are concerned primarily about safety and would push for closed system automation plans before any commercial scale approval where the likelihood of contamination is increased by multiples compared to slow paced trial setting circumstances. Both of these considerations are part of what manufacturing plans submitted to MHRA or other regulators must address. You must have forgotten that part; ). Prevagen?; ). Best wishes.
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