Avirmax CMC Successfully Delivers First GMP Lot of AAV Vector Product for Clinical Trial Use
HAYWARD, Calif., July 17, 2024 /PRNewswire/ — Avirmax CMC, a leader in the innovation and manufacture of adeno-associated virus (AAV) vector-mediated biotherapeutics, announces the successful delivery to its first client with Good Manufacturing Practice (GMP) lots of AAV vector product trial use.
This milestone marks a significant achievement in Avirmax CMC’s mission to provide high-quality gene therapy solutions. The GMP-compliant AAV vectors were produced using Avirmax’s state-of-the-art VSaf™ rBV-Sf9 technology platform, which ensures high titers at extremely low empty capsid ratio, and enhanced expression of the gene of interest (GOI). The delivered vector product will play a crucial role in the upcoming clinical trial, aimed at treating ocular diseases.
“Our team at Avirmax CMC is thrilled to have reached this pivotal point in our journey. Delivering to our first customer with GMP lot of AAV vector product underscores our commitment to excellence and our capability to meet stringent regulatory standards and customer’s satisfaction,” said Dr. Shengjiang Shawn Liu, CEO & CSO of Avirmax CMC Inc. “We are dedicated to advancing gene therapy development for partners and making these innovative treatments accessible to patients in need.”
The GMP AAV product lots were produced, tested and packaged at Avirmax CMC’s cutting-edge facility in the City of Hayward, the heart of San Francisco Bay Area, which is equipped with single use technologies for scalable and robust manufacturing processes. The production process ensures that the vector products meet the highest standards of quality and safety required for clinical use.
The successful delivery of this GMP lot demonstrates Avirmax CMC’s readiness to support clinical trials and contribute to the development of effective gene therapies. The company’s focus on innovation and quality positions it as a key player in the biopharmaceutical industry.
About Avirmax CMC Inc.
Avirmax CMC is dedicated to the innovation, development, and manufacture of AAV vector-mediated biotherapeutics. Based in the San Francisco Bay Area, the company leverages its proprietary technologies to deliver safe, effective, and affordable gene therapy solutions. Avirmax CMC’s mission is to advance gene therapy and improve the lives of patients with ocular and CNS diseases. For more information about Avirmax CMC and its services, please visit Avirmax CMC’s website (https://www.avirmaxcmc.com/).
Contact
June Song, Associate Director for Operations
Email: business@avirmax.com
Tel: +1-510-641-0201
Address
25503 Whitesell Street
Hayward, CA 94545
USA
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SOURCE Avirmax
