tiakis Biotech AG (tiakis), in collaboration with its CDMO partner Northway Biotech, is pleased to announce the successful completion of a technology transfer and ramp-up of manufacturing capabilities for Tiprelestat, a pioneering anti-inflammatory and tissue-protective drug being developed for the prevention of postoperative inflammatory complications following major surgery, treatment of COVID-19 and pulmonary arterial hypertension. For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L.
“The marked increase in manufacturing capabilities lays the foundation for the next stage of tiakis’ development programs, with the recent start of our COMCOVID phase Ib/II clinical trial being a prime example,” said Martin Voss, tiakis Biotech AG co-CEO.
The enhanced production capabilities is a result of the successful completion of a technology transfer and subsequent ramp-up program, achieved in a short time through close collaboration with end-to-end biologics CDMO Northway Biotech, based in Vilnius, Lithuania.
Reflecting on this milestone, Vladas Algirdas Bumelis, CEO of Northway Biotech, stated: “The confidence our partners have placed in our two-decade-long expertise has enabled us to collaboratively scale up the process and meet tiakis’ deadlines. Our state-of-the-art 3,000 L stainless-steel fermenter train was utilized to carry out the implementation successfully. We extend our sincere well-wishes to our partners as they move forward with their innovative drug through clinical trials, and we look forward to future collaborations.”
Andre Markmann, VP Business Development of Northway Biotech, added: “This partnership exemplifies our commitment to assist our partners in achieving their objectives by leveraging our technical expertise and operational capabilities. We are immensely proud to be part of this groundbreaking project, which addresses a significant unmet medical need.”
By attaining this pharmaceutical and technological milestone, tiakis and Northway Biotech have demonstrated their capabilities to pave the way towards groundbreaking achievements as pioneers in their respective fields. The success of this fast-paced project is characterized by strong collaborative interaction, mutual trust, and flexibility between the two companies.
tiakis biopharmaceutical drug candidate Tiprelestat promises an excellent therapeutic benefit-risk profile for use as an anti-inflammatory and tissue-protective drug. Tiprelestat is identical to the human protein elafin with high specificity for tissue-destroying and inflammation-promoting proteases. The development program of Tiprelestat is focused on the late-stage development of Tiprelestat in major surgery and early-stage development in pulmonary arterial hypertension (PAH) and COVID-19.
About tiakis Biotech AG
tiakis focuses on the discovery and development of therapeutic solutions based on its innovative biopharmaceutical Tiprelestat for life-threatening surgeries and life-threatening diseases such as PAH and COVID-19. tiakis seeks partners and investors for the development, commercial-scale manufacturing, marketing and distribution of the product. The company tiakis Biotech AG is located in Kiel, Germany (www.tiakis.bio).
About Northway Biotech
Northway Biotech 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 translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US. Further information can be found on Northway’s website www.northwaybiotech.com.
CEO and Chairman of the Board