Completion of Largest Capacity GMP Run Marks New Standard in Biologics Manufacturing

News provided by

Boston Institute of Biotechnology, LLC

Apr 25, 2024, 10:02 ET

BOSTON, April 25, 2024 /PRNewswire/ -- Boston Institute of Biotechnology, LLC (BIB) in collaboration with BIBo-Biopharma, proudly announces the successful completion of a groundbreaking 30,000L fermentation run, marking a significant milestone in biotechnology history.

The endeavor required tremendous effort and expertise, but BIB and BIBo excelled at every stage, from the initial seed stages to the critical N-1 stage. Utilizing a production fermenter with a capacity of 30,000L, we navigated through the process, including homogenization and IB washes, with exceptional proficiency.

Despite the scale of the operation, our team-maintained control and performance standards equivalent to those of smaller runs, such as our 2,000L fermentations. As we await the final yield and titer results, we anticipate surpassing expectations yet again.

This achievement positions BIB as the first in biotech to undertake such a large-scale operation for upstream primary recovery. Not only is this the largest capacity GMP run to date, but it also sets a new standard for biologics manufacturing.

In an internal release, BIB's senior executive remarked, "We have successfully completed the first ultra-large 30KL fermentation for biologics. This accomplishment underscores our dedication to pushing the boundaries of what is possible, and we are excited to continue driving innovation in the field."

The P03 facility is a marvel of biopharmaceutical engineering, boasting the world's largest single-tank and the first ultra-large-scale production line. Its 24-meter-high building spans 65,000 square meters, housing over 120 kilometers of pipelines, 20 kilometers of clean room air ducts, and nearly 500 kilometers of cables. With 11 million parts and hundreds of core equipment sets, each line comprises over 5,000 key procedures. Remarkably, BIBo and BIB accomplished this complex project in just 18 months, setting a new standard in biopharmaceutical engineering.

The ultra-large bioreactor is a cornerstone of BIB's commitment to innovation and efficiency in bioprocessing. Developed as part of a new generation of systems, it is designed to significantly reduce costs and accelerate time-to-market, empowering the transformation of molecules into impactful medicines that benefit patients worldwide.

For more information, please contact [email protected].

Boston Institute of Biotechnology, LLC:

A leading contract development and manufacturing organization dedicated to advancing healthcare through cutting-edge research, development, and manufacturing. With a focus on innovation and excellence, BIB strives to address unmet medical needs and improve patient outcomes worldwide.

Website: https://bostonbib.com/

SOURCE Boston Institute of Biotechnology, LLC