• Continuous chromatography development accelerator

Bioanalytical

Continuous chromatography development accelerator

BioSC® Predict is the first simulation and optimisation software for the development of continuous chromatography processes dedicated for the purification of biopharmaceuticals.

It is a process development accelerator enabling any scientist to start developing continuous chromatography processes even without prior knowledge. With a few clicks, the user can switch from batch chromatography to an optimised continuous chromatography process.

In biopharma and biotech industries, most of the production steps are still performed batchwise. Among them, batch chromatography is an unrivalled purification technique to reach the stringent quality specifications required by health authorities. For a few years now, the biopharma industry has started implementing continuous processing, and more particularly continuous chromatography, to improve process economics together with process control and understanding.

The development of a batch chromatography step typically requires many experiments to be designed and performed in the lab before finding the right operating conditions. This work costs time (up to several weeks) and money while consuming precious materials which are often limited.

BioSC® Predict provides the user with a solution to reduce this development step to 2-4 experiments and perform the rest in-silico. By providing the software with a few data generated from common batch chromatography experiments, the user can generate a first continuous chromatography recipe and directly run it on BioSC® Lab equipment.

BioSC® Predict is driven by the user’s objectives: with a few clicks, the user can define the practical constraints and the desired strategy (limit the amount of expensive chromatography media, for example). The optimisation algorithms will provide the most adapted operational conditions (number and geometry of columns and flowrates).

BioSC® Predict has been designed to be easy to use even with no prior knowledge on continuous processing. It will be a companion to users looking to increase their understanding of continuous chromatography processes. Since the number of optimisations is infinite, the user can play with the optimisation parameters to quickly generate a large amount of data on the chromatographic system. This feature can be used to characterise the behaviour of the chromatographic system regarding continuous chromatography or simply used to improve the understanding of continuous chromatography processes in general.

Since the implementation of continuous processing is a big challenge right now, a Lite Version of BioSC® Predict is being shared publicly on Novasep website.

BioSC® Predict received the Pharmaceutical Engineering Award at Achema 2015.

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