A decade ago, BioPlan Associates prepared the findings of its 2008 directory of expression system technologies that were being promoted or considered likely to be suitable for commercial licensing for biopharmaceutical manufacturing (1). Due in part to the relatively slow advances in this critical area of bioprocessing, this study remains perhaps the only directory of biopharmaceutical-relevant expression systems available for licensing. Here I discuss aspects of related bioprocessing technologies that have and have not changed in the past decade.
Expression systems refers to the interrelated technologies, including cell lines, genetic constructs, reagents, procedures, and know-how that together are used to develop genetically modified cells for recombinant proteins and antibody manufacturing, including:
- Host cell lines to be genetically modified
- Plasmids or other vectors to transfer or modify gene sequences
- Activation and promoter sequences
- Transfection and clone amplification/selection methods
- Sequence termination technologies
- Other aspects of genetic engineering used to modify host cell lines and select for desired genetically transformed cells.
In many cases, fully integrated “systems” with all needed components have been developed and are available. But some innovators assemble full systems on their own by selecting and combining different component technologies. The technologies involved might be proprietary (whether patented or trade secrets) and thus would need to be licensed from their owners.
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