When Thermo Fisher Scientific were looking to accelerate their biologics operations, they began to think about some of the challenges that happen during biologics development and manufacturing. The company is well known as a provider of chemicals, bioreactors, and analytical instrumentation, but they also provide contractual manufacturing and CRO services.
Elena Gonrtarz is the Head of Scientific & Technical Affairs at Thermo Fisher Scientific. She comes from the CDMO side of the company and outlined the work that the company did to improve their cell line development. There are a few challenges that they came across in this regard. For example, including insufficient titer production for toxicology and clinical studies, and the need for larger-scale bioreactor.
Discussing these challenges internally, Thermo Fisher decided that they needed to partner with an external partner to improve their in-house cell line with new technologies. The partner that they chose were able to incorporate AI/ML vector construction optimisation, transposase technology and an enhanced CHO-K1 cell line, which they could use with their Beacon Optofluidic System.
Gonrtarz explained the transposase technology in further detail. The tool allows the team to move large genes of interest into host cells without DNA fragmentation, resulting in higher titers and better product quality.
Clients often come to Thermo Fisher with multiple candidates for selection to take further. This is to identify potential issues like aggregation and oxidation that could affect drug efficacy and shelf life. Gonrtarz said that therefore, they wanted to tackle these issues early in the process for a greater chance of success.
Gonrtarz then outlined the nine-month timeline that Thermo Fisher works from for bringing a product from transfection to the patient. She stressed the importance of efficient process documentation and technology integration. The role of analytical development was also highlighted, including the use of high-throughput screening systems to understand the behaviour of candidates under various conditions.
The presentation concludes with a focus on the seamless transition from drug substance development to clinical trials and the importance of maintaining high-quality standards throughout the process.
