San Diego, USA, 3 June 2019 – Abzena, the leading biotherapeutics target to GMP partner research organization (PRO) announced an accelerated program to IND. This reduces timeline from stable pool to GMP down to 14 months. The timeline is achieved by use of single project team with experienced leadership, overlapping of operational activities, internal technology transfer within Abzena, proprietary technologies and scalable single use bioreactors.
Abzena builds on a track record of 10 biotherapeutics currently in integrated IND phase of development or early clinical development. The service uses a license and royalty free proprietary CHO cell line and efficient ambr® 15 development, followed by ambr® 250 process development, scaling to Sartorius single use bioreactors of 2 L to 500 L scale, and next year in 2020 to 2000 L scale. The use of clone selection and ambr® technology during cell line development (CLD) reduces project timelines and allows for introduction of at-risk development steps. Risk can be further reduced by addition of Abzena’s proprietary developability assessment service.
Abzena also announced the appointment of Shahram Katousian, as Senior Director and Head of Manufacturing and MSAT in our Biologics GMP facility. He joins Abzena following positions of increasing seniority at Genentech, Amgen, Baxter and Nektar Therapeutics. He brings deep CMC and Regulatory knowledge of clinical and commercial phase manufacturing including late stage BLA enabling activities for commercialization. He received his BS from University of British Columbia and MBA from University of Phoenix.
Jonathan Goldman MD Abzena CEO added: “Patient focused drug development is critical for me personally and for Abzena as an organization. I am delighted to announce this innovation for patients and Shahram’s appointment. His leadership will ensure successful execution on complex programs”.
Shahram Katousian also stated: “I am glad to have joined a talented team at Abzena to bring my experience and help our clients advance their products to the clinic, and ultimately help patients with new therapies”.
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Abzena provides the most complete set of solutions in integrated discovery to clinical phase biopharmaceutical and antibody drug conjugation manufacturing services in the biopharma industry. The company has a global presence to provide support to around the world, with facilities in the US and UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity organizations, headquartered in New York City. For more information, please see www.abzena.com.