spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

Northway Biotechpharma and Hansa Biopharma initiate a new Contract Development and Manufacturing project in immunological diseases

Northway Biotechpharma


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.

Under the terms of this agreement, Northway Biotechpharma will transfer the process developed by Hansa Biopharma to its state-of-the-art R&D and cGMP manufacturing facility to perform further process optimization work. Subsequently, the process will be scaled-up for cGMP manufacturing of the Drug Substance including the production of the Drug Product for Hansa Biopharma´s clinical studies.

Dr. Vladas Bumelis, Executive Chairman of the Board of Northway Biotechpharma, said, “We have developed a strong and successful partnership with Hansa Biopharma over the years and we are happy to extend this cooperation by supporting the development of their new drug candidate”.

“This second project which we will run for Hansa Biopharma will certainly benefit from the manufacturing process and the analytical panel synergies resulting from the previous project. Additionally, our capability as a true one-stop-shop CDMO will add to the smooth execution of all CMC-activities,” added Dr. André Markmann, VP Business Development of Northway Biotechpharma.

Søren Tulstrup, President and Chief Executive Officer of Hansa Biopharma, commented: “We greatly value our professional relationship with Northway Biotechpharma and this project is a cornerstone in developing the next generation of IgG cleaving enzymes to potentially enable repeat dosing in relapsing autoimmune diseases and oncology”.

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 translate 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.

About Hansa Biopharma - https://hansabiopharma.com

Hansa Biopharma leverages its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection, and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Hansa’s research and development program is advancing with the next generation technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and the US.

For Further Information Contact

email bd@northwaybiotech.com
web https://www.northwaybiotech.com/
email Northway Biotechpharma Mokslininku str. 4 LT-08412 Vilnius, Lithuania
 
Print this page
Send to a friend
   
spacer
News and Press Releases

Pharmapack Europe 2020 Award Winners Announced

Exhibitor Innovations 1. Best Innovation in Drug Delivery Device (injectable): The Connect Auto-Sensing Injection System by Credence MedSystems 2. Best Innovation in Drug Delivery Device (respiratory): Safe'n'Spray by NEMERA 3. Best Innovation in Primary Packaging (solid dosage): Push Tab loop by Huhtamaki Flexible Packaging 4. Best Innovation in Primary Packaging (liquid dosage): Pourer Lotus by PACKSYS GmbH 5. Best Innovation in Secondary Packaging: Patient Support App by Rondo 6. Best Innovation in Machinery: Quantifeel Quality Assurance Platform by Smart Skin Technologies
More info >>


White Papers

New Temperature Profiles from a Global Study

Laminar Medica

Recently there has been an influx of temperature mapping studies to collect sufficient ambient data to develop temperature profiles.  Solid temperature profiles on specific shipping routes are required to ensure streamlined packaging and robust lane qualification. The most reliable method to develop temperature profiles is to capture the actual reading from shipments, as well as using the historical and meteorological data to increase the confidence level.
More info >>

Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement