Aesica Introduces Aseptic Micro Dosing Capabilities at Nottingham Site
Product News Nov 05, 2013
Aesica has introduced 3P’s Fill2Weight dispensing system - suitable for all powder formulations including spray dried and lyophilized powders - to its Nottingham site, enabling increased flexibility and reduced time in “first in human” clinical studies.
The Fill2Weight system is widely acknowledged as the most flexible micro dosing system available to the market, with the technology able to dose a wide range of powders and can quickly be scaled up from clinical to commercial production.
Aesica will be offering the system to customers as a tool that enables the direct filling of APIs in to 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 10 µg (10x lower than the market leading competitor). Consequently, Fill2Weight is usable with potent compounds.
With the increased drive from clients and regulatory bodies for Quality by Design (QbD), the micro dosing system’s flexibility and repeatability ensures that experiments can be designed from laboratory scale right through to commercial supply, thanks to the platform’s modular design.
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-500mg, with a dosing accuracy of <3% RSD and cycle feed times of less than two seconds.
The 3P Fill2Weight can be fully sterilized which allows it to be used to aseptically fill re-constitutable powders in to bottles or syringes. This delivers a cost-effective, truly scalable alternative to “in-vial” lyophilization.
A key benefit of working with the Nottingham site has been its ability to develop clinical trial products rapidly and the system will allow for even great reductions in time to market, with the ultimate impact of reduce the costs of development incurred by customers.
Ian Lafferty, Site Director- Aesica, Nottingham, commented: “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 makes 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”.