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Almac has polymorph screening services to support differing research needs and budgets. Our screens are driven by first rate science rather than robotics, with highly trained chemists and analysts directing a customer tailored investigation.
- Preliminary Polymorph Screen - a fast and smart approach when sample size and budget is limited, for example during lead optimisation. With only 200 mg of drug substance, Almac can carry out an effective polymorph screen and identify new forms present.
- Standard Polymorph Screen – designed to find the most stable form of the API and to define the form for clinical development and GMP manufacture. The tendency to form polymorphs, solvates and hydrates in typical processing solvents and under typical process conditions (e.g. drying, milling and compaction) is thoroughly investigated.
- Extensive Polymorph Screen - designed to generate as many new forms of the API as possible, by using a wide and diverse range of experimental conditions. Augmenting traditional screening methods with novel crystallisation techniques allows Almac to access unusual high energy metastable states, which can lead to novel crystalline forms of an API.
- Robustness of Form – designed to identify the solid forms of the API most likely to be produced during the stresses of processing and on exposure to formulation components. Polymorph screening on all new drug substances has been required by the regulatory authorities since the publication of ICH Q6A in 1999. However, drug products launched prior to this date may not have had a rigorous investigation into their tendency to change physical form. As a result, the unexpected appearance of new forms can appear years after product launch or after seemingly minor changes to the API manufacturing or formulation processes. Alterations of form can lead to batch failures, reductions in efficacy and even product withdrawal.