Aesica introduces aseptic micro dosing capabilities at Nottingham plant

Published: 4-Nov-2013

New technology can be used with capsules, vials, inhalers, injectables, blisters and high potents

Aesica, a global contract development and manufacturing organisation (CDMO), has introduced 3P’s Fill2Weight dispensing system to its Nottingham site in the UK, adding increased flexibility and reduced time in clinical studies.

The Fill2Weight system is suitable for all powder formulations including spray dried and lyophilised powders and can be quickly scaled up from clinical to commercial production.

Aesica will offer the system to customers as a tool that enables the direct filling of APIs into capsules, syringes or bottles, eliminating the time and cost associated with developing a blended formulation.

Developed to fill a target weight, rather than dispensing fixed volume, Fill2Weight dynamically measures and records the dispensed weight of all doses, allowing for compensation in powder property changes without the need for intervention or re-calibration.

The flexibility offered by the platform means that the micro dosing system can be used across capsules, vials, blisters, injectables or inhalers and weighting resolutions as low as 10µg, making it usable with potent compounds.

The micro dosing system’s flexibility and repeatability ensures that experiments can be designed from laboratory scale to commercial supply.

Moreover, multi-track production settings limit process changes in the final stages of product development and provide tighter regulation of process controls. Quality is enhanced with reduced weight variability, lower rejection levels and 100% weight recording, meaning the system is suitable for real-time release, monitoring and recording. The system is configurable for doses between 2.5mg to 500mg, with a dosing accuracy of <3% RSD and cycle feed times of less than two seconds.

Increasingly clients are coming to our Nottingham site with the knowledge that we have the capabilities to develop virtually any dosage form and delivery mechanism

The 3P Fill2Weight can be fully sterilised, which allows it to be used to aseptically fill re-constitutable powders into bottles or syringes.

Aesica says this delivers a cost-effective, truly scalable alternative to 'in-vial' lyophilisation.

Ian Lafferty, Site Director at Aesica, Nottingham, said: 'Increasingly clients are coming to our Nottingham site with the knowledge that we have the capabilities to develop virtually any dosage form and delivery mechanism. It is this flexibility and, crucially, the speed with which we can develop these products that has proved the main driver of our growth.

'The Fill2Weight system is widely regarded as the best-in-market micro dosing system. Indeed, its delivery flexibility, reproducibility and scale-up variability make it the ideal complement to existing services. Ultimately, our goal is to get our clients to 'first-in-human' solutions as quickly as possible, reducing time consuming and expensive development work.'

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