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Quotes from industry leaders like Neeraj Sharma (One-Source Specialty Pharma) and others underline that regulatory infrastructure and specialised capabilities remain the biggest challenges, even where basic capacity exists

Training lab personnel in these techniques is not optional

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While direct injection or shaking may produce a clear solution faster, clarity does not equal bioactivity

J., Hauer, P., Millar, L., Gould, M., Tran, P., Shikuma, C., Souza, S., and McArthur, J

For others, the opposite happens