Abzena 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.