Teknova, which produces life science reagents, opened its newest GMP-certified production facility which, the company claims, will enable bioprocessing and gene therapy companies to get into the clinic faster.
Located in Hollister, CA, the modular manufacturing facility recently received ISO 13485:2016 certification for the production of GMP-grade products. Previously operational for research-grade production, the new facility adds more than 10,000 ft2 of GMP-certified ISO cleanrooms and provides a three-fold increase in overall manufacturing capacity.
“We kept hearing from our customers that they wanted a partner who could support them with custom reagent manufacturing as they scale from research, through process development, and into clinical trials, particularly in batch volumes of less than 2,000 liters,” said Stephen Gunstream, president and CEO. “We built this facility to do just that, and we look forward to leveraging our facility’s modular manufacturing capabilities to continue supporting our customers throughout various stages of their lifecycle.”
With expanded formulation, dispensing, cleanroom, and warehouse space—including increased automation to support single-use needs and animal-free and endotoxin-controlled environments, the “new GMP-certified facility exemplifies Teknova’s modular manufacturing platform, further enabling the flexible, scalable, and consistent production of high-quality reagents,” added Gunstream.
