Only companies that have strong platforms will be able to meet specific timelines, says Bristol-Myers Squibbs’ Jim Xu.
As COVID-19 transitions into an endemic, delegates at Biotech Week Boston discussed the challenges concerning the upstream process development process. Jianlin (Jim) Xu, scientific director, biologics development at BMS, explained told a packed room that monoclonal antibodies (mAbs) are difficult to produce with complex glycosylation profile, process related impurities, and amino acid oxidation.
Xu also outlined other challenges, which included bioreactor operation scalability, upstream processes lasting over a month for one run from vial thaw to harvest, competitive development of similar mAb products in the industry, and the length of time it takes to create stable monoclonal CHO lines with desirable characteristics.
To solve said challenges, Xu maintained that a strong platform “is the number one solution,” and that a robust platform can help a firm meet particular timelines. He said that a platform approach has numerous benefits, from decreasing costs, shortening development timelines, and making it possible to have a robust production process from clinical supply through to commercial use.
Xu claimed that in order to develop upstream platform technology, the individual and/or company must be able to “demonstrate the benefit and proof-of-concept of an upstream technology” in the first instance. Additionally, he told delegates that the technology should be successfully applied to various mAb products, and this will provide a “good starting point” for future mAb manufacture process development.
In other platform related news at Biotech Week Boston, PerkinElmer launched its Cellaca PLX system, saying that it is the cell analysis solution to streamline cell and gene therapy research and production.