The new modular manufacturing facility will help bioprocessing and gene therapy companies scale from research to clinical production. Credit: Natali _ Mis/Shutterstock.com.

Alpha Teknova has opened a new modular manufacturing facility in Hollister, California, US, for custom high-quality life sciences reagents.

The facility will help bioprocessing and gene therapy companies scale from research to clinical production.

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The new facility was previously operational for research-grade production. Following the ISO 13485: 2016 certification, it will now produce GMP-grade high-quality reagents.

A number of 10,000ft² GMP-certified ISO cleanrooms will provide a three-fold increase in overall manufacturing capacity. Expanded formulation, dispensing, warehouse and cleanrooms with increased automation support single-use needs and provide animal-free and endotoxin-controlled environments.

Teknova president and CEO Stephen Gunstream stated: “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.

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“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.

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“We built this facility to do just that – in the city that 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 company also offers customisable solutions to support companies involved in molecular diagnostics, synthetic biology, and cell and gene therapy.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.