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Solutions to Common Small Molecule Drug API Manufacturing Challenges: Solid Form Isolation

Contract Development and Manufacturing Organizations (CDMOs) evaluate and transfer many small molecule active pharmaceutical ingredient (API) processes. In our experience, the chemistry that is presented in the technical packets frequently represents a medicinal chemistry process or a cursory attempt at a scalable route. Therefore, the API often requires significant further […]

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The Advantages of Wet Mill Micronization in Pharmaceutical Manufacturing

Particle size reduction techniques such as micronization are an essential aspect of pharmaceutical manufacturing operations – and their importance continues to grow. Micronization and other particle reduction techniques are a mainstay in addressing poor drug solubility. Once an exception rather than a rule, most new drug compounds today are highly […]

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6 Top Chiral Chromatography Questions

A chiral molecule is one in which the stereoisomers are mirror images of each other. These mirror images – an example of molecular symmetry – are referred to as enantiomers (see image at right – courtesy of Wikipedia). From a separation standpoint, chiral molecules pose unique challenges. Because they are […]

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How to Identify and Control Drug Impurities Quickly with a Holistic Approach

Impurity isolation and identification in active pharmaceutical ingredients (APIs) and pharmaceutical drug products (DPs) is a critical aspect of the development process. The need to meet the quality guidelines outlined by the ICH (International Conference on Harmonisation) and adopted by regulatory agencies worldwide would be the most obvious reason. But […]

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Are Offshore CROs the Best Choice for Initial Drug API Quantities?

Picking and choosing CROs and CDMOs based solely on cost can ultimately raise project costs and slow your drug development and commercialization. Several weeks ago, we were approached by a company seeking an initial preparation of 20-25 grams of an API. They were a small pharma firm, with a limited […]

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