Andelyn Biosciences provides contract development and manufacturing organization (CDMO) services specializing in viral vector and plasmid manufacturing for gene therapies. The company addresses the need for reliable production of clinical-grade materials to accelerate the development of treatments for rare diseases with unmet medical needs.
Funding
$5M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
The gene therapy field faces challenges in the reliable and scalable production of viral vectors and plasmids, which are critical components for delivering therapeutic genes to patients, especially those with rare diseases and unmet medical needs. Inconsistent manufacturing processes and lack of specialized expertise can delay clinical trials and limit the availability of life-altering treatments.
Solution
Andelyn Biosciences is a contract development and manufacturing organization (CDMO) specializing in the production of viral vectors and plasmids for gene therapies, offering a comprehensive suite of services from concept to commercialization. Leveraging decades of pioneering research and experience, Andelyn provides process and analytical development, GMP drug substance manufacturing, and advanced quality systems to accelerate gene therapy programs. The company's expertise in both adherent and suspension-based manufacturing, combined with its AAV Curator® Platform, enables efficient tech transfer, streamlined process optimization, and scalable production of high-quality gene therapy products. Andelyn's facilities are designed to support various stages of gene therapy development, ensuring a seamless path from preclinical studies to commercial manufacturing.
Target Audience
Andelyn Biosciences serves biotechnology and pharmaceutical companies developing gene therapies, particularly those focused on rare diseases, as well as research institutions and organizations requiring viral vector and plasmid manufacturing services.
Features
- Viral vector manufacturing using both adherent and suspension-based systems
- Plasmid manufacturing for research, toxicology studies, and GMP production
- Process development services to optimize manufacturing processes
- Analytical development and quality control testing to ensure product quality and compliance
- Technology transfer services for seamless integration of client processes
- AAV Curator™ Platform for streamlined AAV construct design and optimization
- The DIGITAL CDMO® Platform for data-driven process management and optimization
- GMP manufacturing for clinical trials and commercial production
- Advanced quality systems and regulatory support
- Semi-automated to automated fill stations