Vilnius, Lithuania, and Copenhagen, Denmark – December 18th 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Synklino, a company active in developing a therapeutic protein‑based therapy as treatment for cytomegalovirus (CMV) infection, announced today that they entered into a Development and Manufacturing Agreement for the recombinant fusion protein SYNx, which Synklino aims to bring into clinical trials.
Under the scope of the agreement, Northway Biotechpharma will develop the USP- and DSP-process in its state-of-the-art R&D and cGMP manufacturing facility, before scaling up to final manufacturing scale for cGMP manufacturing of the Drug Substance and Drug Product for Synklino's clinical studies.
Prof. Vladas Bumelis, Executive Chairman of the Board of Northway Biotechpharma, stated, “We are happy and proud to start a cooperation with Synklino on this interesting compound. Our capabilities are a perfect fit for the technical requirements of this project”.
“Our broad experience as a CDMO will help to provide Synklino with GMP material in time for their ambitious development timelines.” commented further Dr. André Markmann, VP Business Development of Northway Biotechpharma.
“We are pleased to work with such a professional, experienced and agile European manufacturer who demonstrates a clear understanding of our specific development and manufacturing needs”, said Thomas N. Kledal, CEO and Founder, from Synklino. Dr. Mads G. Jeppesen, CMC Project Director added further “It is of immense value for a small company like us to be met with a flexible attitude regarding development.”
About Northway Biotechpharma - https://www.northwaybiotech.com
Northway Biotechpharma is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translates to the ability to rapidly execute multiple projects from its state-of-the-art GMP facility while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotechpharma is a privately owned company founded in 2004 and located in Vilnius, Lithuania.
For Further Information Contact: bd@northwaybiotech.com
About Synklino - https://synklino.com
Synklino is developing a drug candidate, SYNx, aiming to eradicate cytomegalovirus (CMV) infection. SYNx is being developed for patients undergoing a solid organ or stem cell transplantation, preventing late-onset CMV disease. Late-onset CMV currently causes suboptimal transplantation outcome, leading to increased morbidity, prolonged hospitalization, and raised mortality rates. SYNx is a highly effective, potent, and fast-acting CMV-specific immunotoxin with the unique ability to kill lytic and latently infected cells. The technology allows for the highly efficient treatment of CMV infected transplant recipients and can also treat organs and cells ex vivo before organ or stem cell transplantation.
For Further Information Contact: tnk@synklino.com
Press release PDF
Please find our press release offered for download in a PDF form below:
Press release: NBPTH and Synklino enter CDMO agreement