[Case Study on Culture Media] Establishing a Liquid Culture Media Supply System for a Major Biopharmaceutical Company
Supply system for sterile liquid media for antibody pharmaceuticals.
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)
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【Features】 - Manufacturing environment compliant with GMP - Production line capable of handling small quantities and a variety of products - Extensive use of single-use equipment - Strict raw material management - Containers compatible with bottles and single-use bags 【Our Strengths】 We are a joint venture between Ajinomoto Co., Inc. and Koji Bio Co., Ltd. By combining Ajinomoto's high-quality amino acid-based culture media raw materials and formulation development technology with Koji Bio's advanced liquid culture media production technology, we provide high-quality liquid culture media.
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In June 2018, we established Ajinomoto Koji Bio Co., Inc. as a joint venture between Ajinomoto Co., Inc. and Koji Bio Co., Inc. We combined Ajinomoto Co., Inc.'s high-quality amino acids as the foundation for culture media raw materials and their formulation development technology with Koji Bio Co., Inc.'s advanced liquid culture media production technology to launch a contract manufacturing company for clinical culture media necessary for regenerative medicine. Currently, we are engaged in contract manufacturing of liquid media and buffers for customers in cell therapy and biopharmaceuticals, enhancing our significance in the industry.