Lewa GmbH Develops Low-Pressure Chromatography System
Nowhere are the requirements of precision, quality, and reproducibility as strictly regulated as in modern process chromatography. Using the Ecoprime low-pressure chromatography system developed by Lewa GmbH, batch-to-batch reproducibility in GMP manufacturing of biopharmaceuticals can be enhanced significantly and the yield of the product can be enhanced.
The system is notable within its product family for its extremely precise flow control from 0.03 to 60 liters per minute, its unrivaled dynamic flow rate range, minimal pulsation, and low holdup volume, allowing better product yield, purity, and safety during purification. As a consequence, production time and the costs of validation in the entire production cycle are able to be reduced.
The pumps installed in the systems and registered for patent approval with the servo drive from Lewa operate with the highest precision and allow high reproducibility of the adjustable parameters. Compared with other systems, a considerably higher accuracy over the entire flow rate range can also be covered with its Intellidrive technology. Each Ecoprime system therefore offers an adjustment range of 1:150 or more. Because the Ecoprime system can handle the flow rate of up to three individual conventional process systems, investment costs and valuable floor space can be reduced. It is therefore ideally suited for use in cost-intensive GMP cleanrooms.
In the previous year, a license agreement with ChromaCon AG was sought to extend the Ecoprime batch chromatography platform, which applies to the use of Capture SMB technology, among others, at pilot and GMP scale for continuous purification. This allows various process principles such as batch or multi-column chromatography, Capture SMB, and MCSGP process principles to be undertaken with the same system platform. In addition, the contract between both companies enables them to further accelerate the development of modern cost-reducing purification processes for the manufacturers of biopharmaceuticals at GMP scale.
Picture: With the diaphragm metering pumps of the Ecoprime chromatography system from Lewa, processes can be reproduced with the highest precision. The entire design of the product-wetted piping system is optimized for the best fluid dynamics. The assembly of the system is compliant with all pharmaceutical requirements and ensures that the system can even be placed in confined cleanroom spaces.
(Image: Lewa GmbH)
Source: LEWA GmbH
