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Abzena Bolsters Development Timeline Capabilities

Unveils 14-month cell line to phase 1 GMP service; appoints Shahram Katousian as head of biologics manufacturing

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Abzena has introduced an accelerated cell line development program to IND, which it says reduces the 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.
 
In addition, Abzena has appointed Shahram Katousian as senior director and head of manufacturing and MSAT in its 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.

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