Alpha Teknova, a producer of critical reagents for the research, development, and commercialisation of novel therapies, vaccines, and molecular diagnostics, has announced the opening of their newest GMP-certified production facility. This facility has been built to enable bioprocessing and gene therapy companies to get into the clinic faster.
Based in California, the company’s state-of-the-art 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 square feet of GMP-certified ISO cleanrooms and provides a three-fold increase in overall manufacturing capacity.
“Our team has worked tirelessly over the past two years to build our new GMP-certified production facility here in Hollister and its opening represents a momentous milestone in our company’s evolution,” said Stephen Gunstream, Teknova’s President and CEO.
The company’s state-of-the-art modular manufacturing facility recently received ISO 13485:2016 certification for the production of GMP-grade products
“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 litres," Gunstream added. "We built this facility to do just that – in the city we’ve called home for almost 20 years – and we look forward to leveraging our facility's modular manufacturing capabilities to continue supporting our customers throughout various stages of their lifecycle.”
“The San Benito County Chamber of Commerce is thrilled to congratulate Teknova on the opening of their latest manufacturing facility in Hollister, California,” said Michelle Leonard, CEO of the San Benito County Chamber of Commerce. “As a leading employer and long-time partner in the County, we’re incredibly appreciative of the investment they continue to make in Hollister, providing essential jobs to the area, and increasing our visibility as a key location for the biotech and pharmaceutical industry.”
Cleanroom automation and monitoring
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 that the company is known for.
Bioprocessing and gene therapy companies are now able to work with one trusted partner across the entire clinical pipeline, accelerating their breakthroughs as they transition from RUO to GMP.
