How to Scale Lab Cell Therapy Process to cGMP Manufacturing
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development approach. Advanced therapy medicinal products are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit, based on a patient-specific target. This new manufacturing approach is in contrast with current biomanufacturing processes for compounds that are synthetically derived (i.e. small molecule) or proteins expressed by cellular systems (i.e. large molecule biopharmaceuticals); our traditional fed-batch approach to product manufacturing. The challenge of how to develop process and facility solutions will be the focus of an exciting interactive workshop at the Biomanufacturing Conference, sponsored by the Biotechnology Community of Practice.