My last post gave a short introduction to the manufacture of in vitro transcribed (IVT) messenger RNA (mRNA) for vaccines and therapies, outlining the steps from preclinical to clinical stages of production. In this post, I’ll touch on manufacturing considerations, beginning with the upstream process for IVT mRNA.
Witnessing firsthand the growth of cell and gene therapy to progress more programs to the bedside is an exciting time in the biotechnology industry, particularly with new partnership approaches being developed. I was able to get an overview of one particular partnership during a podcast featuring Tom Foti, VP of Protein Business unit at Aldevron, and Kris Saha, Ph.D., Associate Professor of Biomedical Engineering, Medical History and Bioethics at the University of Wisconsin.
Every year, October marks the change in the season, the dropping of temperatures, and the height of conference season for biotech. This year’s ESGCT meeting in Edinburgh, Scotland, was the event’s first in-person occurrence since 2019, and it was exciting to be back – Edinburgh didn’t disappoint! There was rich dialogue amongst industry experts, healthy attendance with over 2,000 delegates, exceptional networking events, and the city of Edinburgh was a joy with several unseasonably sunny days.
As one of the most significant discoveries in gene and cell therapy, CRISPR/Cas9 genome editing systems continue to evolve. In this webinar, “Genome Editing Tools: Beyond Discovery,” Aldevron experts Dr. Jim Williams and Max Sellman detail innovative tools to support gene editing clinical programs, highlighting Nanoplasmids as an HDR template paired with Cas9 nucleases in CAR-T applications.
In cell and gene therapies, delivery is a critical factor. Regardless of your modality, optimizing payload, impact, and duration are common challenges. Countless programs, globally, are working on the delivery mechanism. However, many have overlooked a key component in improving therapeutic or manufacturing performance: the plasmid.
Cell and gene therapies (C>s) comprise a rapidly expanding segment of the life science industry. Due to this growth, companies can encounter significant challenges when scaling their therapeutics from research through clinical trials to commercialization.
The C> industry is working to standardize manufacturing processes and practices, and here at Aldevron we have joined forces with multiple industry consortia to help address these challenges.
Justin Byers, Client Relations Senior Manager, GMP Custom Protein Services at Aldevron discusses important considerations for achieving GMP quality protein manufacturing for advanced therapeutics and vaccines.
He was interviewed by Michael Dunnet for TIDES TV.
This article was originally published in the October 26, 2018, edition of The Forum of Fargo-Moorhead and is republished here in its entirety.
