Fabian Gerlinghaus
CEO and Co-Founder, Cellares
Fabian Gerlinghaus is driven by a strong sense of purpose and is passionate about building the future of cell therapy manufacturing. Prior to Cellares, he was chief innovation officer at Synthego and co-invented the company’s RNA synthesizer technology. His aim and vision for the future of the company is to be the de facto standard for cell therapy manufacturing.
We asked…
What is your most controversial opinion about the field?
Though I acknowledge the necessity for standardization in our industry, the US Congress has directed the FDA to standardize processes, and the FDA has responded by introducing the Advanced Manufacturing Technologies (AMT) Designation. This initiative aims to standardize cell types and manufacturing technologies, a goal that perfectly aligns with Cellares’ mission. Presently, the FDA is grappling with overwhelming challenges due to the 2,800 cell therapies in development, each with its own CMC package in regulatory filings that require the regulators’ review. This results in redundant work across different bioprocessing and process development labs of various biotech companies. This repetition, such as repeatedly redoing process development for white blood cell enrichment, lacks value and underscores the need for standardization. I intend to establish the industry standard for cell therapy manufacturing.
