Abzena plc, the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has selected Sartorius Stedim Biotech as its preferred equipment supplier in the U.S.
Abzena has selected Sartorius Stedim to equip its integrated CDMO facilities in Bristol, PA (development and GMP manufacture of antibody drug conjugates) and San Diego, CA (development and GMP manufacture of monoclonal antibodies and other recombinant proteins).
Sartorius Stedim will provide both facilities with end-to-end process solutions in single-use (SU) format. It will equip Abzena’s San Diego process development lab with leading industry technologies such as Ambr250, enabling fast scale up to 500L initially and later to the 2000L scale single-use bioreactor for its centre of excellence in clinical manufacturing.
John Burt, Abzena CEO, commented: “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 ensuring that we can rapidly develop a robust and reliable process that can be easily scaled up to ensure a smooth technology transfer.”
Reinhard Vogt, Sartorius Executive VP commented: “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.”
About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1,052 million euros.
Abzena (AIM: ABZA) provides proprietary technologies and complementary services to enable the development and manufacture of biopharmaceutical products. The term ‘ABZENA Inside’ is used by Abzena to describe products that have been created using its proprietary technologies and are being developed by its partners, and include Composite Human Antibodies™ and ThioBridge™ Antibody Drug Conjugates (ADCs). Abzena has the potential to earn future licence fees, milestone payments and/or royalties on ‘ABZENA Inside’ products. Abzena offers the following services and technologies across its principal sites in Cambridge (UK), San Diego, California (USA) and Bristol, Pennsylvania (USA):
- Immunology research studies, including immunogenicity assessment of candidate biopharmaceutical products;
- Protein engineering to create humanized antibodies and deimmunised therapeutic proteins;
- Cell line development for the manufacture of recombinant proteins and antibodies;
- Contract process development and GMP manufacture of biopharmaceuticals, including monoclonal antibodies and recombinant proteins for preclinical and clinical studies;
- Contract synthetic chemistry and bioconjugation research services, focused on antibody-drug conjugates (ADCs);
- Proprietary site-specific conjugation technologies and novel payloads for ADC development; and
- GMP manufacturer of ADC linkers, payloads & combined linker-payloads.
Sartorius Stedim Biotech
Vice President of Corporate Communications