Glycostem moves into new lab, production and HQ facility
Glycostem relocated to its new facilities at Pivot Park, Oss, Netherlands. Collectively comprising nearly 500 square meters, the premises include the company’s stateof-the-art laboratory, production facility and administrative HQ.
The facilities were completely refurbished and customised for Glycostem’s particularly specialised applications. In preparation for future expansion, Glycostem also retains an option on an additional space of about the same size.
Troels Jordansen, Glycostem CEO, said “It’s not unusual for an advanced biotech company to have access to high-tech R&D facilities. It is, however, a luxury that we were able to design our own state-of-the art production facility.” He further explains, “When we surveyed the CMO market, it was clear that the large players invested in very expensive Class A and Class B cleanrooms. These became, more or less, redundant after the new EMA regulation was put in place in May of 2018. At the same time, there is no CMO experience with closed system technology.”
Jordansen adds, “Glycostem will be one of the first cellular immunotherapy companies to enter clinical trials with a Class-C cleanroom. The benefits include minimal set-up investment and minimal maintenance costs.”
Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company focused on developing off-the shelf allogeneic cellular immunotherapy using Natural Killer (NK) cells to treat several types of cancer. NK-cells are the body’s first line of defence because of the innate ability of NK-cells to rapidly and accurately identify and destroy cells under stress, such as cancer or virally-infected cells. Glycostem’s lead product, oNKord® , is produced in a closed system in Glycostem’s state-of-theart production facility in The Netherlands, from which the product can be distributed globally. The platform technology includes ex vivo expansion of a high number of pure and highly activated NK-cells for clinical applications. oNKord® successfully concluded phase I clinical trial (elderly and fragile AML patients), providing solid safety data and strong indication of clinical activity, including response on MRD. Glycostem expects to obtain GMP certification by the end of 2018 and is planning to enter pivotal clinical trial in Q1 2019. Thanks to the six patent families, longstanding technical expertise and resources, as well as ‘Orphan Drug Designation’, Glycostem has secured a leadership position in the global NK-cell market.