Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services is a global contract development and manufacturing organization (CDMO) dedicated to improving the health of humankind through adaptive solutions and responsive service. The company offers a comprehensive portfolio of manufacturing and development services across small molecule, large molecule, gene therapy, and specialty pharmaceutical categories.

Service Capabilities:

• Small Molecule Manufacturing
• Large Molecule Manufacturing
• Gene Therapy Manufacturing
• Oligo & Peptide Synthesis
• Highly Potent & ADC Services
• Product Quality & Analytical Services
• Development Services

Operational Philosophy: The organization emphasizes customer focus, innovation, accountability, and compliance. Quality management teams maintain continuous improvement practices and ensure inspection readiness for regulatory agencies and customers. The company maintains Drug Master Files and Biologics Master Files with CDER and CBER, respectively, and provides Site Master Files for regulatory review.

Global Infrastructure: With locations in Belgium, United States, Japan, and India, Ajinomoto Bio-Pharma leverages global infrastructure to support biotechnology and pharmaceutical companies worldwide. The regulatory support team has contributed to numerous clinical and marketing application submissions and supports regulatory filings and commercial launches.