Prestige Biopharma Limited

Prestige Biopharma Limited

PL
Company Profile

Prestige Biopharma Limited

Singapore, Singapore

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About

Prestige Biopharma (PBP) is a Singapore-based biopharmaceutical company focusing on discovery, research, development and registration of biosimilars, first-in-class antibody drugs and vaccines, with the aim of finding cures and preventive medicines for devastating diseases, and to provide through our partners access to affordable quality biologics to the patients of the world. Prestige Biopharma strives to become a global innovator through the development of first-in-class antibody therapeutics including PBP1510 anti-PAUF mAb for pancreatic cancer (INN-ulenistamab) that obtained orphan designation from FDA, EMA and MFDS. Another 10 bispecific antibody projects based on PBP’s proprietary oncology therapeutic targets, PAUF and CTHRC1, are currently in development. Prestige Biopharma’s rich portfolio of biosimilars in various stages consist of the lead program, HD201, a trastuzumab biosimilar, currently under review by Health Canada and Korean MFDS, HD204, a bevacizumab biosimilarin Phase 3 of clinical development and planned to be filed in Q4/2023, PBP1502 an adalimumab biosimilar currently in phase I. Other biosimilars in the pipeline include aflibercept, eculizumab, ipilimumab, nivolumab, pembrolizumab, pertuzumab, and others. Prestige Biopharma’s area of capabilities also includes full value chain technological platform for drug discovery leading to expedited development, from drug discovery, non-clinical and clinical development, to regulatory registration and global commercialization together with our partners. Prestige Biopharma, together with Prestige Biologics, also expanded its business into development and manufacturing of vaccines at global scale vaccine center, starting with partnered commercial production of COVID-19 vaccines, and collaboration in developing next generation vaccines for potential future pandemics. Prestige Biopharma’s dedicated manufacturing facility, Prestige Biologics, is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercialization. With its fully established antibody drug and vaccine manufacturing capabilities, Prestige Biologics offers CDEMO services in which customized engineering solutions are provided for manufacturing process in a customized manufacturing suite speed-built with its proprietary technology, ALITA Smart BioFactory™. Currently, a total production capacity of 154,000L with Full Single-Use System and ALITA Smart BioFactory™ is available for global clients. About Prestige Biopharma Limited PRESTIGE BIOPHARMA LTD (PBP) is a rapidly-expanding, biopharmaceutical company, with an Innovative Drug Development Platform from Discovery to CMC analysis to GMP Product Manufacturing. We are pioneers in pancreatic cancer, with novel antibody drugs and diagnostics targeting PAUF (biomarker for pancreatic cancer) under development. We also specialize in development and manufacturing of biosimilars. Located in Busan, Korea’s second largest city, the Innovative Discovery Center (IDC) stands as Prestige Biopharma's global-scale R&D center, serving as the nucleus for pioneering novel drug development initiatives. Equipped with cutting-edge scientific infrastructure, IDC is dedicated to developing novel therapeutic antibodies to overcome unmet medical needs. Leveraging expertise and resources, we focus on first-in-class antibody drugs addressing life-threatening diseases and fostering innovation. To fulfill these roles, our scope covers from the initial stages of target identification, through the critical steps of the mechanism of action (MoA) studies, lead finding and optimization, to comprehensive preclinical studies, culminating in the IND (Investigational New Drug) filing. Additionally, we are dedicated to the in-house development of cell line development (CLD) technologies, focusing on engineering cell lines that can produce therapeutic proteins at high yields. Moreover, we develop bioanalytical analysis methods to ensure the integrity and performance of our biologics. This integrated approach ensures that the IDC contributes significantly to successful drug development. IDC aims to establish an open innovation platform by fostering synergy between science and technology, implementing a comprehensive innovative drug platform (‘Plug and Play’) and offering shared lab opportunities, allowing global academic institutions, enterprises, or entrepreneurs to assemble and collaborate for the development of pharmaceutical solutions. Prestige Biologics, our dedicated CDEMO, provides One-Stop Solutions for biomanufacturing from drug development to commercial manufacturing. We provide comprehensive support throughout the drug development lifecycle, including technical research, manufacturing process development, engineering, clinical production, commercial manufacturing, clinical support, and IND and BLA filings. Through this integrated approach, we deliver the most effective services to our customers in the rapidly evolving biopharmaceutical market. About Prestige Biopharma Limited PRESTIGE BIOPHARMA LTD (PBP) is a rapidly-expanding, biopharmaceutical company, with an Innovative Drug Development Platform from Discovery to CMC analysis to GMP Product Manufacturing. We are pioneers in pancreatic cancer, with novel antibody drugs and diagnostics targeting PAUF (biomarker for pancreatic cancer) under development. We also specialize in development and manufacturing of biosimilars. Located in Busan, Korea’s second largest city, the Innovative Discovery Center (IDC) stands as Prestige Biopharma's global-scale R&D center, serving as the nucleus for pioneering novel drug development initiatives. Equipped with cutting-edge scientific infrastructure, IDC is dedicated to developing novel therapeutic antibodies to overcome unmet medical needs. Leveraging expertise and resources, we focus on first-in-class antibody drugs addressing life-threatening diseases and fostering innovation. To fulfill these roles, our scope covers from the initial stages of target identification, through the critical steps of the mechanism of action (MoA) studies, lead finding and optimization, to comprehensive preclinical studies, culminating in the IND (Investigational New Drug) filing. Additionally, we are dedicated to the in-house development of cell line development (CLD) technologies, focusing on engineering cell lines that can produce therapeutic proteins at high yields. Moreover, we develop bioanalytical analysis methods to ensure the integrity and performance of our biologics. This integrated approach ensures that the IDC contributes significantly to successful drug development. IDC aims to establish an open innovation platform by fostering synergy between science and technology, implementing a comprehensive innovative drug platform (‘Plug and Play’) and offering shared lab opportunities, allowing global academic institutions, enterprises, or entrepreneurs to assemble and collaborate for the development of pharmaceutical solutions. Prestige Biologics, our dedicated CDEMO, provides One-Stop Solutions for biomanufacturing from drug development to commercial manufacturing. We provide comprehensive support throughout the drug development lifecycle, including technical research, manufacturing process development, engineering, clinical production, commercial manufacturing, clinical support, and IND and BLA filings. Through this integrated approach, we deliver the most effective services to our customers in the rapidly evolving biopharmaceutical market. Prestige Group has a comprehensive value chain platform, encompassing the entire drug discovery cycle, from R&D to manufacturing, clinical development, regulatory registration and commercialization, bringing innovative therapeutics to the market seamlessly and efficiently to address unmet medical needs. Prestige Biopharma Limited (PBP) is a Singapore-based biopharmaceutical company dedicated to the discovery, research, development and registration of biosimilars and first-in-class antibody drugs with a strong focus on oncology and immunology. Located in Busan, Korea, the Innovative Discovery Center (IDC) stands as PBP's global-scale R&D center, fostering innovation, and driving the development of biologics including first-in-class antibody drugs and platform technologies aimed at addressing life-threatening diseases. Our scope spans the full range of activities, from early discovery and target identification to comprehensive preclinical studies, culminating in the Investigational New Drug (IND) filing for clinical trial initiation. Additionally, IDC has established a robust cell line development (CLD) system to engineer high-yield therapeutic protein-producing cell lines. PBP’s dedicated manufacturing facility, Prestige Biologics, is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercial supply. Currently, a total production capacity of 154,000L with Full Single-Use System is available for clients worldwide.

Address
21 Biopolis Road, #04-24 Nucleos South Building, Singapore 138567, Singapore