" class="no-js "lang="en-US"> Capsida Biotherapeutics Unveils Next-Generation Gene Therapy Manufacturing - Medtech Alert
Friday, March 01, 2024

Capsida Biotherapeutics Unveils Next-Generation Gene Therapy Manufacturing

Capsida Biotherapeutics Inc., a fully integrated biotechnology company creating a new class of targeted adeno-associated virus (AAV) gene therapies for patients with debilitating and life-threatening genetic disorders, today announced the opening of its state-of-the-art manufacturing facility in Thousand Oaks.

As a fully integrated gene therapy company, Capsida is unique in its end-to-end expertise – which includes AAV engineering, cargo development and optimization, translational biology, early capsid manufacturability, clinical development, and state-of-the-art manufacturing.

“One of our key strategic priorities at Capsida is to create therapies that can be manufactured consistently and rapidly while maintaining the highest quality,” said Rayne Waller, chief manufacturing officer of Capsida Biotherapeutics. “Our new manufacturing facility eliminates the dependence on contract manufacturing which will allow us to bring products seamlessly from discovery into clinical studies faster. In addition, our robust process development and analytical capabilities are cornerstones of our ability to reliably produce high quality gene therapies to meet worldwide regulatory expectations.”

“After many months of work, we’re thrilled to open our new GMP manufacturing facility, which will be a critical component in bringing our AAV gene therapies to patients,” Waller continued. “With our new manufacturing operations and industry-leading talent, working with state-of-the-art equipment and processes, we can respond to changes immediately and pivot rapidly to make improvements.”

The 15,000 square-foot good manufacturing practice (GMP) manufacturing facility includes two ballroom production suites, a fill suite, and an in-house quality-control laboratory. Capsida’s proprietary manufacturing processes will take advantage of single-use equipment to aid in quick and effective product changeovers and equipment cleaning. The facility will employ between 40 and 50 people and is designed to include unidirectional flow for both staff and raw materials to increase environmental control.

“The fact that we were able to go from detailed design to mechanical completion in less than a year is incredible,” said Rob Murphy, vice president of manufacturing, Capsida Biotherapeutics. “The faster we are able to produce clinical supplies, the faster we’ll be able to get our innovative gene therapies to the patients who need them. This was all made possible by our fantastic team and our terrific partners.”

“The opening of Capsida’s manufacturing facility is a milestone not only for the company, but also for all of us in the Thousand Oaks region,” said Thousand Oaks mayor Claudia Bill-de la Peña. “Thousand Oaks is quickly becoming an integral part of the Greater Los Angeles Biotech hub and Capsida’s leading-edge gene therapy capability will attract a breadth of high-quality talent to the City of Thousand Oaks.”

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