Sartorius will equip Abzena’s Pennsylvania and California facilities with disposable and scale-up technologies.
Biopharmaceutical contract development and manufacturing organization (CDMO) Abzena is expanding operations at its Bristol, PA, and San Diego, CA facilities, and it has chosen Sartorius Stedim Biotech as its preferred equipment supplier in the US.
Abzena is consolidating its West Coast biomanufacturing operations (monoclonal antibodies and other recombinant proteins) into a single state-of-the-art, 50,000-sq.ft facility at Lusk Boulevard in San Diego and remodeling the facility to include biomanufacturing cleanrooms that accommodate 500 and 2000-liter bioreactors. At its Bristol, PA facility, which specialized in the development and GMP manufacture of antibody drug conjugates, the company is constructing a GMP conjugation suite that should be operational near the end of the first quarter of 2018.
Both facilities offer integrated services, and Sartorius Stedim will provide end-to-end single-use solutions designed for each. In a first phase, the process development laboratory at Abzena’s San Diego biopharmaceutical facility will be equipped with Ambr250 mini-bioreactors for high-throughput development work, enabling fast scale-up to 500 L. Later on it will be providing a 2000-L single-use bioreactor for clinical manufacturing.
“We are pleased to have been selected by Abzena, a prominent global CDMO with a comprehensive industry portfolio across a wide range of modalities to supply single-use solutions that enable process development, tech transfer and GMP manufacturing. We look forward to working together to best serve the US and international markets,” said Sartorius Executive Vice President Reinhard Vogt.
Added John Burt, CEO of Abzena: “In addition to having selected Sartorius’ industry leading single-use technologies for antibody and ADC production, the Abzena facilities will feature Umetrics process analytics software throughout the process, ensuring that all the data captured throughout our clients’ molecule development is transformed into process knowledge. [This ensures] that we can rapidly develop a robust and reliable process that can be easily scaled up to ensure a smooth technology transfer,” said Abzena’s CEO, in a company press release.