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.
Avirmax CMC Inc. Successfully Delivers GMP
Lots of AAV Vector Products for Client's Phase I/IIa Clinical Trial
in the US
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