The demand for new biopharma products is pushing biotechs to explore approaches that can speed production of promising candidates. But in many cases these methods may arrive with attendant baggage which limits their utility.
Celltheon is a contract manufacturing organization (CMO) that takes on especially recalcitrant protein molecules. Its CEO, Amita Goel, discussed the company’s strategy for dealing with these hard to express proteins.
“We have spent four years building our expression platform, using artificial intelligence software to optimize each facet of the biosynthetic process,” she explained. “We screen a large number of clones, making sure we confront the scalability issue early on.”
This strategy ensures that the researchers won’t waste time pursuing a clone that will not perform properly on an industrial scale, she added, and eliminates proteins that are prone to aggregation, one of the most serious defects found in many therapeutic candidates.
Celltheon scientists designed their own vectors and modified a number of standard cell lines to fit their protocols. These constructs are the subject of a number of recently filed patent applications.
“Using our technologies, we have built a portfolio of 12 different biosimilar molecules as candidates for treating various infectious diseases,” continued Goel. “These constitute seven families of patents covering cell lines, expression constructs, and unique expression elements covering applications from cell line development, cell therapy, bioproduction, and gene therapy.”
However, much of the firm’s activities are fee for service, tailoring monoclonal antibodies, growth factors, and other biologically active molecules to behave obediently, while at the same time retaining their selected function. Goel stressed that the company is not involved in the manufacturing phase of production.
“We engage clients who have encountered difficulty getting their molecule to express appropriately, and then we hand them the finished product for further manufacturing options,” she said.
From the inception of a project the staff zeroes in on the cellular and molecular level, defining what is working and what is not, to bridge the gap between upstream and downstream processing. There is always a focus on alternatives to cut redundancy and speed the project along, said Goel. In this way it is possible to collapse the timeline—whereas initially five to six months were required to produce high quality clones, it is now feasible to cut the time required to completion down to two months, she explained.
In summarizing the company’s direction and focus, Goel described the company’s mission as a technology stack that builds on the previous one.
“We are seeking to integrate our philosophy, in which we apply proteomics and genomics to designing therapeutic molecules through the use of automation and high throughput technologies,” she explained. “So we are striving to move to the level of Bioprocessing 5.0.”