Accentus to 'revolutionise' crystallisation

Accentus C³ Technology has launched a unique in silico predictive crystallisation capability that the company says is set to revolutionise the way the life science industry approaches crystallisation problems.

Branded as CrystalGEM, the technology is a result of an agreement with Chiralabs and its extensive research experience guided by Dr George Tranter.

The technique can be applied to pharmaceuticals and organic molecules including their salt forms. Unlike other computational models which have historically attempted to predict crystallisation from the molecular level and have proved to be of limited value, the structurally driven CrystalGEM technology is based on the analysis of thousands of real crystallisation systems using single or mixed combinations of more than 80 commercially available solvents, coupled to a proven proprietary pattern recognition algorithm.

CrystalGEM allows the prediction of solubilities and an indication of crystallisation outcomes in mixed solvent conditions. Data on likely crystallisation, morphology, habit and polymorphism are obtained, allowing the efficient selection and ranking of conditions worth experimental exploration. Importantly, the approach rapidly highlights areas of solvent space that have the highest chance of becoming a system suitable for scale-up and manufacture, making the requirements for high cost, high throughput crystallisation screening obsolete. When coupled with in-house micro-crystallisation technology, compounds can be effectively and efficiently screened and may give single crystals suitable for further crystallographic analysis if required.

The company has also launched a new protein crystallisation process development service that is specifically targeted towards the rapidly growing needs of the emergent biopharmaceutical industry. ProteinXL is a result of an extended collaboration with Chiralabs and uses circular dichroism (CD) to determine the three dimensional protein structure and interactions under realistic industrial or natural conditions. When coupled with in-house micro-crystallisation screening technology, compounds can be efficiently screened and may also give single crystals suitable for further crystallographic analysis if required.

Novel proteins and biopharmaceuticals (collectively NBEs) represent the fastest growing therapeutic class in pharmaceuticals. However, unlike most small molecule pharmaceutical moieties, they are typically not manufactured in a crystalline form (except insulin). The complex multilevel structure and complex folding and refolding interactions make efficient repeatable crystallisation extremely difficult at industrial scale, although the crystalline state holds many subsequent advantages. A reliable crystalline form is therefore highly desirable and can deliver added value benefits in optimising production, improving product stability pharmacokinetic profile and method of drug delivery.

Dr Tranter said: 'Efficient production of NBEs represent a tremendous industrial challenge and the desire for reliable crystalline forms is growing from both an innovator and regulatory perspective. While most NCE syntheses can be readily and repeatedly characterised, the biopharmaceutical industry is only just beginning to realise the importance of crystalline and morphological issues. Our joint added value screening and cutting edge analysis should enable the rapid generation results that can be directly used by the industrial user.'