Wave Bioreactor Technology™
The Company has made a strategic decision to implement the Wave Bioreactor single use bag-technology. In April 2007 GE Healthcare acquired Wave Biotech and Wave Europe. The Wave Bioreactor product line has changed the face of cell culture, seed train and production operations from a labor-intensive process, contamination-prone, stainless steel, to a cost effective, quickly commissioned, disposable process using bag based systems rather than steel containers.
The Wave Bioreactor is the growth platform Recopharma uses to generate recombinant cells under controlled conditions using predictable levels of oxygen, pH and other critical parameters. While the culture time is essentially the same, the sterile and disposable cell bags are much simpler to use because they require no maintenance and eliminate the potential for contamination between cultures.
Down-stream processing
Downstream of the Wave Bioreactor, Recopharma use the ÄKTA explorer chromatographic system to purify Recopharma mucin-based biopharmaceuticals.
With the ÄKTA explorer Recopharma is capable of rapidly developing and optimizing purification strategies for a broad array of biomolecules in a multi-step, high-throughput fashion.
In processes, the ÄKTA explorer serves an important tool for the initial capture and isolation of the mucin-immunoglobulin Fc fusions from the culture medium, as well as in subsequent purification steps to ensure the production knowledge of biomolecules to the highest possible purity.
BioProfile FLEX
The BioProfile Flex provides Recopharma with immediate data from 15 key parameters in one modular cell culture analyzer, like glucose, glutamine, lactate, ammonium, pH, oxygen and carbon dioxide levels, and also cell density and cell viability. These parameters are key to regulate for higher cell densities and hence higher productivity.
ACQUITY Ultra Performance Liquid Chromatography (UPLC)
The ACQUITY Ultra Performance Liquid Chromatography analytical separation system from Waters ensures the rapid and high resolution separation of different metabolites. This equipment gives the exact amounts of different nutrients, such as amino acids and sugars, available in the cell medium. The staff can at every time provide the necessary nutrients for optimal cell growth and productivity.
Millipore Cogent
The Cogent filtration system from Millipore is used in two steps. Firstly, depth filters are connected to separate the cells from the medium containing the product. Secondly, small pore filters are used to exchange the expended medium for a defined buffer to minimize variation in the subsequent chromatographic capture step. With the Cogent, parameters such as flows and pressures are logged in order to maintain control and allow for easy scale-up of processes.
Pre-Clinical Research
The Recopharma leads based on purified mucin-type fusion proteins with tailored O-glycan substitution are structurally and functionally validated using different analytical techniques as well as various cell-based in vitro assays and in vivo disease models.