味の素コージンバイオ Product Lineup

We provide contract manufacturing of buffers used in the manufacturing processes for biopharmaceuticals, vaccines, and cell therapies. We offer aseptic filling in containers tailored to our customers' requirements. 【Features】 ● GMP-compliant manufacturing environment Equipped with a video monitoring system in the manufacturing room Air conditioning and water facilities are monitored by an environmental monitoring system ● Strict raw material management Operated with a Manufacturing Execution System (MES) ● Adaptable to small quantities and a variety of products Introduction of single-use processes Stable and short delivery times ● Thorough quality control Analysis items are tailored to customer requests ● Stable procurement of materials Achieved stable procurement of materials through cooperation with domestic single-use manufacturers *Consultation available regarding implementation audits.

Ajinomoto Co., Inc. is working with domestic single-use product manufacturers to ensure stable procurement and achieve short delivery times. 【Requested Specifications】 ● 2D Single Use bag: 500mL, 1L, 2L, 10L, 20L ● 3D Single Use bag: 50L, 100L, 200L Customization is possible to match customer specifications, including tube length and connectors. We kindly ask you to consult with us. *If you wish to purchase single-use bags only, we will introduce you to a domestic single-use manufacturer contact.

In the pharmaceutical industry, particularly in the quality control department, the quality of the liquid media used for cell culture is a crucial factor that influences the safety and efficacy of products. Media manufactured in a GMP-compliant environment is essential to minimize the risk of contamination and ensure the reliability of test results. Our services provide sterile filling into containers tailored to customer requirements in a GMP-compliant manufacturing environment, supporting solutions to challenges in quality control. 【Usage Scenarios】 - Procurement of media in the cell culture process - Stabilization of media quality in the quality control department - Transition from research and development to clinical trials 【Benefits of Implementation】 - Quality assurance through GMP compliance - Increased efficiency in research and development due to stable supply - Cost reduction and shortened delivery times

1. Overview of Provided Content We provide broad support for custom media based on unique recipes, from research to commercial production. ◆ Types of Media: Original base media, Original feed media ◆ Process: Support from subculture to main culture ◆ Supply Formats: Bottles, various single-use bags (2D/3D) 2. Steps to Implementation We ensure a reliable implementation in 4 steps. (1) Prototype (Trial production at Engiran) (2) Culture Evaluation (Performance evaluation with actual cells) (3) Operational Design (Identifying issues and discussions) (4) Start of Main Supply (GMP-compliant system) 3. Supply and Logistics Scheme We have established a seamless network from raw material supply to product movement by coordinating our manufacturing base with external warehouses. We maintain thorough temperature control from room temperature to refrigerated and frozen conditions. 4. Benefits of Implementation ◆ Reduction of Labor Hours: Decrease in man-hours by outsourcing media preparation tasks ◆ Production Efficiency: Reduction of preparation errors and equipment maintenance risks ◆ Focus on Core Operations: Concentration of resources on core activities (drug discovery and process development)

In the vaccine manufacturing industry, there is a demand for streamlining the manufacturing process to ensure a stable supply of high-quality products. In particular, the quality of the culture media used for cell culture is a crucial factor that influences the efficacy and safety of vaccines. Mistakes in media preparation or variations in quality can lead to decreased manufacturing efficiency and quality issues with the products. Our liquid media is produced in a GMP-compliant manufacturing environment, providing stable quality to support the resolution of challenges in vaccine production. 【Usage Scenarios】 - Cell culture processes in vaccine manufacturing - Preparation processes for cell culture media - Stabilization of media quality 【Benefits of Implementation】 - Reduction of labor hours through outsourcing media preparation tasks - Decreased risk of preparation errors and equipment maintenance - Concentration of resources on core business (vaccine manufacturing)

In the field of regenerative medicine, the quality and safety of cells are the most important issues. The culture media used for cell culture must promote cell proliferation and provide a stable supply of high-quality cells. Our products are manufactured in compliance with GMP standards and strongly support cell culture in regenerative medicine. 【Application Scenarios】 - Cell therapy - Biopharmaceutical development - Research and development 【Benefits of Implementation】 - Stabilization of cell culture - Supply of high-quality cells - Increased efficiency in research and development