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By Andrei Blasko, Clearview Pharma Solutions LLC | Most of the instability problems of a drug product come from excipients; in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatibility. |
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By Erica Friedman, senior research analyst, BioPlan Associates | It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply. |
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By Amnon Eylath, Broad Spectrum GXP Consulting | Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations. |
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LIFE SCIENCE LEADER MAGAZINE |
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business. |
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