Prestige Biopharma Enters Strategic MOU With Charles River, A Global Contract Research Organization

• Collaborating to Accelerate Development and Commercialization of Biosimilars and Novel Antibody Therapeutics
• Integrating a Full-Coverage Value Chain: From Discovery, Preclinical, and Safety Testing to Process Development and GMP Manufacturing
• Driving Global Business Expansion and CDMO Pipeline Growth through Strategic Networking and Joint Marketing

Prestige Biopharma Limited, a global biopharmaceutical company, announced today that it has signed a strategic Memorandum of Understanding (MOU) with Charles River Laboratories International, Inc., a premier global life sciences company headquartered in Massachusetts, U.S., to collaborate on the development, testing, analysis, and manufacturing of biopharmaceuticals.

The collaboration leverages the unique strengths of both organizations: Charles River’s world-class expertise in preclinical and analytical services and Prestige Biopharma Group’s robust capabilities in antibody therapeutic development and Contract Development and Manufacturing Organization (CDMO) services.

Together, the companies aim to streamline and accelerate the path to commercialization for biosimilars and novel biologics.

The collaboration integrates specialized services across the entire drug development lifecycle, ranging from discovery and preclinical safety assessments to analytical testing, process development, and GMP manufacturing. Key areas of cooperation include:

• Analytical method development and validation
• Quality control (QC) and batch release testing
• Biosafety, viral safety, and cell line characterization
• GLP-compliant toxicology studies
• Pharmacokinetic (PK) and pharmacodynamic (PD) research

Charles River, having supported the development of over 80% of all drugs approved by the U.S. Food and Drug Administration (FDA) over the past five years, brings unparalleled expertise to this collaboration. By utilizing Charles River’s comprehensive testing and analytical solutions with Prestige Biopharma Group’s antibody manufacturing expertise, the companies intend to offer enhanced support for clients seeking entry into major regulated markets, including the U.S. and Europe.

The collaboration also initiates a joint business development strategy utilizing the companies' respective global networks. Charles River will refer clients requiring biopharmaceutical process development and GMP manufacturing to Prestige Biopharma Group, while Prestige Biopharma Group will connect clients in need of early-stage discovery, preclinical toxicology, and bioanalytical services to Charles River.

With Charles River’s core focus on preclinical drug development and analytical testing services, this collaboration creates a highly synergistic model that optimizes both companies’ capabilities to expand their respective project pipelines and capitalize on new business opportunities.

Furthermore, the companies plan to increase their global presence through joint marketing initiatives, including participation in major industry conferences, joint seminars, and the collaborative development of white papers and technical marketing materials detailing scientific breakthroughs.

"This collaboration with Charles River, a global leader in preclinical and testing services, marks a pivotal milestone in directly connecting our antibody development and manufacturing expertise with a broader global client network," said a spokesperson for Prestige Biopharma. "By combining our specialized skill sets, we will significantly enhance the efficiency of biopharmaceutical development while aggressively expanding our global CDMO order pipeline and long-term business development opportunities."

Prestige Biopharma Group continues to solidify its global footprint by focusing on its core businesses: biosimilars, novel drug development, and CDMO services. Building on recent successful collaborations with global pharmaceutical leaders, the group remains committed to strengthening its foundation for sustained growth in the biopharmaceutical development and manufacturing sector.