OEM / Introduction & Process

Introduction

BioEngine has the leading capability to produce high-performance and high-quality serum-free culture media. With its strong production capacity, BioEngine can provide a more competitive price to customers, where our production capacity is 500,000 liters/year for liquid media and 1,300 tons/year for powder media, with the largest batch of powder media being 2.6 tons (100,000 liters). We completed the process validation for scaling up our automatic, low-temperature cone mixing/pin milling (CMPM) processes at the 1,000L, 10,000L, 100,000L scales, ensuring the stability and reliable quality of our culture media. Our manufacturing site implements information management to guarantee the accuracy and reliability of our data to meet relevant requirements of the quality management systems across the world. We also established a comprehensive quality inspection and management system for the supply of raw materials in accordance with GMP audit requirements. We follow the “2 local +1 imported” raw material supplier model, achieving the domestic substitution for more than 80% of raw materials required for serum-free media production, ensuring stable and rapid production and supply, minimizing the impact of import and export trade.