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.
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.
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.