Alvotech and Prestige Biopharma, today announced a new contract manufacturing partnership for one of Prestige Biopharma´s biosimilar candidates.
Alvotech’s Contract Services have been selected from a wide range of well recognized contract development and manufacturing organizations.
Under this partnership, Alvotech Contract Services will be responsible for commercial production using its new state-of-the-art biosimilar facility in Reykjavik, Iceland, where the manufacturing process will be scaled up and process validation performed. Alvotech and Prestige Biopharma will immediately commence technology transfer, followed by commercial manufacturing of the compound.
Mark Levick, Alvotech’s Chief Executive Officer said:
“The partnership with Prestige BioPharma marks an important milestone for our company as we work towards expanding our contract manufacturing business. We are pleased to be trusted with the responsibility of delivering high quality manufacturing services to Prestige Biopharma and look forward to further collaboration in the future. We pride ourselves on delivering highest quality commercial production from one of the best biopharma facilities in the world.”
Alvotech’s contract manufacturing services include:
- Cell line, process, analytics development or transfer
- Scale-up and GMP manufacturing (multiple 2000L)
- Aseptic DP filling: vials and PFS
- Process characterization, validation and commercial supply
- Regulatory support
Alvotech adds value to client’s biopharma programs by bringing experience, professional teams and state-of-the-art facility together with high quality, regulatory and IP consulting to ensure successful market entry.
Alvotech is a biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world.
Alvotech’s contract manufacturing unit (Alvotech Contract Services) is embedded within the organization. The unit offers extensive expertise and capabilities for biosimilar and innovative large molecules development as well as commercial supply from a new GMP certified state-of-the-art facility based in Reykjavik, Iceland. The manufacturing facility is well equipped with a number of 2000L bioreactors, aseptic filling lines for vials and pre-filled syringes, state-of-the-art development laboratories, all required facilities and equipment, in addition to world-class regulatory and clinical teams that support projects covering the entire value chain.
About Prestige Biopharma
Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed with EMA and will also be filed with USFDA in 2019. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea.