Biologics have great potential for the treatment of many diseases, especially regarding unmet medical needs, due to their target specificity. Moreover, even for diseases where small molecule therapies already exist, there is potential for biologics to provide a more effective solution. However, developing a biologic can often be more challenging compared to their small molecule counterparts. They are more likely to become unstable, have more complex structures, and therefore require more specialized development and manufacturing processes, next to the fact that living organisms are involved in the process which leads to further volatility. It is important to work with a contract development and manufacturing organization (CDMO) that can match these requirements, accommodate challenges in a flexible way and keep the development process moving towards commercialization.
At the solemn meeting of the Klaipėda University (KU) Senate, the regalia of Honorary Doctor was bestowed upon academician and CEO and Chairman of the Board of Northway Biotech Prof. Habil. Dr. Vladas Algirdas Bumelis.
In Vilnius, Lithuania, a pivotal moment was marked with the first topping-out ceremony at the BIO CITY complex, a project developed by the Northway Healthcare Group. This event signifies substantial progress in constructing what is set to be Europe's largest biotechnology city. The Gene Therapy Center, a cornerstone of this complex, is steadily advancing towards its completion.
Northway Group is embarking on a project to establish Europe’s largest biotechnology hub, BIO CITY, in Vilnius, the capital of Lithuania. It includes 6 large biotechnological complexes – 4 state-of-the-art GMP manufacturing plants and 2 advanced scientific research centres – that will be built in an area equivalent to 10 football fields.The total investment for this biotech campus is projected to reach approximately 7 billion euros over the next decade.
MIAMI, FL and VILNIUS, Lithuania – August 1, 2023 – iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, and Northway Biotech, an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), today announced they have entered into a partnership agreement for the manufacturing of iTolerance's Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the proprietary iTOL-100 platform technology. The SA-FasL fusion protein has shown great potential in pre-clinical studies, establishing durable, localized immune tolerance and enabling implanted tissue, organoid, or cell therapy to function as a viable replacement for damaged native cells.
Waltham, MA, US - June 8, 2023 – Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art cGMP manufacturing site in Vilnius, Lithuania, has marked a significant achievement with the completion of its cGMP manufacturing facilities expansion project in Waltham, Massachusetts. This growth extends the firm's existing track record in delivering state-of-the-art biopharmaceutical solutions to partners worldwide.
Waltham, MA, US - May 24, 2023 – Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art cGMP manufacturing site in Vilnius, Lithuania, announced the completion of its expansion project for cGMP manufacturing facilities in Waltham, Massachusetts. This significant accomplishment further solidifies Northway Biotech's standing as an influential player in the global biopharmaceutical landscape.
Kiel, Germany, May 16, 2023 – 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.
SYDNEY, AUSTRALIA – 06 December 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, announced today that a GMP compliant manufacturing process has been established for IMP761, its proprietary preclinical candidate for autoimmune diseases. The 200L scale attained by Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), will ensure supply of IMP761 for IND-enabling studies and ensuing clinical trials.
SYDNEY, AUSTRALIA – 16 December 2021 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has signed a Manufacturing Service Agreement (MSA) with Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of clinical testing.
WALTHAM, Mass and VILNIUS, Lithuania, and NEW ORLEANS and LONDON – June 9, 2021 – Northway Biotech, a global end-to-end biopharmaceutical contract development and manufacturing organization (CDMO), announced today that it has entered into a partnership with Revolo Biotherapeutics ("Revolo Bio" or the "Company"), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, to manufacture Revolo Biotherapeutics' binding immuno-regulatory protein, ‘1805.
In 2019, companies, working in the Lithuanian biotechnology sector, have shown a growth of 24% in revenue, exceeding 1 billion Eur. The sector is expected to maintain the same rapid pace in 2020 as well. However, entrepreneurs and scientists, working in the industry believe that the future growth should be even faster, while the pandemic, the green deal of the European Union and the funding from the EU Recovery and Resilience Facility could become an incentive for a rapid leap of the Lithuanian biotechnology sector.
Waltham, MA, US – January 20, 2021 – Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art, cGMP manufacturing site in Europe, announced at the virtual grand opening ceremony today, the opening of its new 30,000 square-foot process development and cGMP manufacturing site in Waltham, Massachusetts.
Vilnius, Lithuania, and Waltham, MA, US - December 9, 2020 - Northway Biotechpharma, providing end-to-end contract drug development and manufacturing (CDMO) services, announces brand name change to Northway Biotech. Along with the tradename change, Dr. Vladas Algirdas Bumelis also returns to the helm as Chief Executive Officer at the company he founded.
Vilnius, Lithuania, and Schlieren, Switzerland – August 11, 2020 – Northway Biotechpharma (Northway), a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Swiss biotech company Memo Therapeutics AG (MTx), announce a new partnership to manufacture MTx’s therapeutic COVID-19 antibody candidate in a 4-month fast-track process approved by regulatory authorities.
Vilnius, Lithuania, and Zurich, Switzerland – June 25, 2020 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Swiss biotech company Memo Therapeutics AG have signed a Development and Manufacturing Agreement for a therapeutic antibody.
Vilnius, Lithuania, and Solna, Sweden – February 06, 2020 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Swedish biotech company Affibody, announced today that they signed a Manufacturing & Supply Agreement.
Vilnius, Lithuania, and Lund, Sweden - December 20th, 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced a new service agreement to develop the next generation of IgG cleaving enzymes.
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.
Northway Biotechpharma, a leading biopharmaceutical contract development and manufacturing organization (CDMO), celebrates its 15th anniversary today. As a midsized CDMO, Northway Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. The company focuses on understanding its customers and meeting their specific needs without binding them to one single approach. It is able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet its customers’ evolving needs. On average, Northway Biotechpharma has 25–30 development projects underway each year, ranging from gene cloning to final drug product manufacturing.
