Baculovirus expression technology, or BEVS, gained its first broad industry exposure in the early 1980s, primarily through the many papers published by students and post-doctoral fellows in Dr. Max Summers’ laboratory at Texas A&M University (College Station, Texas). This technology fostered popular appeal because of its simplicity and high protein expression capabilities. As more work was done, it became even more evident that this was a very rapid, and relatively inexpensive method for producing proteins. It was also postulated that BEVS would offer a valuable means of producing recombinant proteins for use in human therapy, especially since baculovirus was considered non-infectious to human cells. It was thought that any problems with post-translational modifications of the manufactured proteins could be worked out, and fully functional glycoproteins could be manufactured…
BioProcessing Journal Posts
We have developed a procedure for large-scale enrichment, growth and harvesting of T cells suitable for adoptive immunotherapy. In two recently completed clinical trials, we investigated the feasibility of immune reconstitution in patients with HIV infection, or with relapsed/refractory Non-Hodgkin’s Lymphoma (NHL) following infusions of autologous activated CD4+ T cells or CD4+/CD8+ T cells. Autologous T cells were activated via CD3/CD28 stimulation, ex vivo, and were then reinfused…
As you stand on the brink of finalizing your first Investigational New Drug (IND) application for a cellular therapy product, there is always the question looming in the back of your mind. “What did we forget?” Hopefully, the answer is “Nothing.” However, it is always good to undergo a review of the standard systems needed in order to transition from research to clinical manufacturing. This article describes an overview of the basic regulatory guidelines and quality systems necessary to begin clinical trials under the regulations of the Food and Drug Administration. However, this should only be considered a guideline, as it does not necessarily address the standards of other regulatory agencies. The investigational product, the clinical indication, and the manufacturing materials used in the investigational product can also change the regulatory requirements needed to proceed with the initiation of clinical trials…