Case studies

Evidence-based formulations A different approach

Combination of two drugs: Two track development of an NCE and a known API.

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Why integrated services benefit the project

In an ideal situation, a drug substance is developed, manufactured and then made available to a drug product/ formulation team…

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When time is everything

A big pharma company’s CMO was hit with an import alert. This could have adversely impacted the market supply of…

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Developing a safe and scalable drug substance

Enantiomerically enriched molecule entering phase III. Its synthesis involved pyrophoric reagents, labile liquid intermediate and potential genotoxic impurities

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DoE and QbD based process development and manufacturing

Reduction of aromatic ring systems at elevated temperatures with large quantities of catalyst, long cycle time, control of unknown impurity…

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Product development in a challenging IP landscape

Identifi­cation of suitable chiral reagent for chemical resolution, process validation, desired polymorph

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Low yield challenges of atypical reaction

Seven stage sequence involving protection-deprotection sequence, labile intermediates and signi­cant by-product formation with low yield

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How the re-designed synthesis of a complex carbohydrate can reduce cycle time.

Complex carbohydrate chemistry involving a linear sequence of 10 chemical transformations, unstable intermediates and column chromatographic purifications

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