Eden Biologics has developed its own proprietary CHO-K1 cell line and uses this cell line for its own products and those of contract partners. Eden has established process development expertise that allows fine control of protein characteristics. Our robust development platform and scale-up strategies reliably translate from 3L models to GMP manufacturing at 2,000L, reducing the need for time consuming and costly iterations at full scale. Eden has a comprehensive, state-of-the art analytical portfolio applying orthogonal methods and is capable of developing liquid and lyophilized formulations. Eden’s facility utilizes identical single-use manufacturing technologies provided by GE, Millipore, and other leading vendors. Our unified technical platform simplifies process development, manufacturing, and technical transfer. We have experience manufacturing batches for regulatory submission at, 50L, 200L, 500L, and 2,000L scales and have successfully designed and conducted clinical trials of biologics.
Our state-of-the-art facility is designed and built to meet highest FDA and EMA GMP requirements globally. Eden’s primary focus is on safety, compliance and flexibility. We strive to combine development with clinical and commercial demands for many products and to meet the needs of customers both today and for many years to come.
Our operations are fully integrated, with drug substance, drug products and quality control testing and release within the same location, to support a lean and efficient flow. We are using single use technology to minimize cleaning validation and product changes over time.