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Monthly Archives: September 2017

Leveraging QbD for API Scale Up

Posted on September 17, 2017 by

Earlier this month we wrote a piece on the Five Challenges Scaling Up an Active Pharmaceutical Ingredient (API). In the post’s conclusion, we discussed the role of QbD in aiding…

Posted in API synthesis, APIs, Design of Experiment, method development, Neuland Labs, QbD, Quality, regulatory, Uncategorized | Comments Off on Leveraging QbD for API Scale Up

5 Common Challenges Scaling Up an API

Posted on September 3, 2017 by

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Comments Off on 5 Common Challenges Scaling Up an API