Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider.
Featuring: Greg Bleck, Vice President of Research and Development, Catalent.
In July 2021, Catalent released its GPEx Lightning expression construct for Chinese hamster ovary (CHO) cell-line development (CLD). Bleck characterized it as a novel combination of the companyâ€™s original GPEx retrovector gene-insertion technology, a glutamine synthetase (GS) knockout sequence, and a recombinase gene-insertion system. A key advantage of the platform, Bleck explained, is that it can reduce CLD timelines by three months. Generated cell lines show high stability and express antibodies in concentrations of 5â€“12 g/L, even without optimization. GPEx Lightning cell lines also offer predictable scalability, enabling users to take CLD and optimization off the critical path. Bleck noted that such features could be particularly advantageous for small biotechnology companies that must meet clinical milestones quickly to secure funding for subsequent activities.
Catalent has developed comprehensive capabilities to support CLD from receipt of a gene of interest to clinical- and commercial-scale manufacturing. Early CLD activities occur primarily at Catalentâ€™s site in Madison, WI. Good manufacturing practice (GMP) production processes can take place at that site or at Catalentâ€™s facility in Bloomington, IN. A site under construction in Oxford, UK, will support process development, including scale-up to manufacturing for toxicology studies, clinical studies, and ultimately, commercialization.
Bleck explained that biopharmaceuticals now account for 51% of the companyâ€™s business. Thus, expansions in CLD and associated services are meant to bolster other capabilities, including those for drug-substance and drug-product manufacturing. The goal is to provide end-to-end services that can address the needs of any drug-development program.
Fill out the form below to view the full BPI Theater webcast.