Empowering Biopharma Innovation with State-of-the-Art Expansion
AGC Biologics recently completed a significant expansion of our Heidelberg site, greatly enhancing our capacity to deliver high-quality biopharmaceutical products. This expansion incorporates several state-of-the-art facilities, ensuring efficient and safe production, storage, and analysis.
Warehouse
The newly expanded 258m² warehouse, maintained at 15°C - 25°C, supports 170 pallets and 850 small parts locations, complemented by an external GMP warehouse with an additional 150 pallet spaces. Real-time temperature and humidity monitoring systems with alarm capabilities ensure optimal storage conditions, and the validated warehouse management system guarantees compliance with industry standards. Additionally, 28 GMP-qualified cold storage freezers at -80°C (125m²) are available for API storage in various primary packaging formats, such as bags, bottles, and containers.
Sampling & Weighing
In the dedicated sampling and weighing rooms (cleanroom class C), AGC Biologics has implemented advanced digitization, with weighing software interfaced with the warehouse management database to promote accuracy and efficiency.
Upstream & Downstream
The upstream process development now features cutting-edge tools like the CELL-tainer® single-use machine and Cedex® Bio Analyzer in the microbial upstream fermentation lab, which also includes 1 L DASGIP® fermentation systems and a small-scale pDNA and mRNA lab. The lab utilizes a static mixer for continuous cell lysis for pDNA release, ensuring high-quality results.The downstream purification lab, equipped with the ÄKTA avant™ and BIO-RAD Gel Doc, ensures high-quality purification processes. Moreover, the new analytical development lab, housing UPLC Systems and CE, enables precise analytical development. The expanded upstream manufacturing now includes a GMP production fermenter (1,500 L with 1,000 L working volume), stainless steel tanks for protein refolding (up to 500 L volume), and a 5,000 L refolding tank. This significantly boosts manufacturing capacity, supporting the production of insoluble proteins via inclusion bodies, secreted proteins, and intracellular soluble proteins.
This expansion reaffirms AGC Biologics' commitment to innovation and excellence in biopharmaceutical manufacturing, ensuring they remain at the forefront of the industry.
