Viral Vector Manufacturing
Andelyn Biosciences collaborates closely with you throughout the development and commercialization of your cell and gene therapies, from initial research and development to establishing a reliable clinical and commercial supply. As a trusted AAV manufacturing CDMO and cell and gene therapy CDMO, we support you at every step, ensuring seamless development and manufacturing through expert viral vector process development and rigorous, GMP-compliant viral vector manufacturing.
GMP Viral Vector Manufacturing CDMO
With Andelyn’s AAV Curator® Platform, cell culture and purification expertise, formulation, automated fill-and-finish, an experienced MSAT team, and the highest standards for quality control, quality assurance, and regulatory support, we deliver cost-effective solutions tailored to your needs. As a cell and gene therapy CDMO and an AAV manufacturing CDMO, we pair viral vector process development with phase-appropriate GMP viral vector manufacturing to accelerate your path from research to commercialization.
GMP Scales
Andelyn Corporate Center
Step inside the Andelyn Corporate Center (ACC), our built-for-purpose facility designed to meet the demands of cell and gene therapy manufacturing. With the latest advances in GMP compliance, the ACC is currently producing high-quality viral vectors, including adeno-associated virus (AAV) and Lentivirus (LVV), optimized for clinical trials and large-scale production. Discover how our facility advances life-saving gene therapy products to market through optimized, industrialized processes, backed by GMP viral vector manufacturing discipline and robust viral vector process development.
Late-Stage Capabilities for
Your Vector Program
Our GMP facility supports programs from Phase 1 through late-stage and commercial production, avoiding facility changes and tech transfers throughout your program's regulatory journey. As an AAV manufacturing CDMO, we align viral vector process development with GMP viral vector manufacturing to support comparability, PPQ, and BLA readiness.
Process Characterization (PC)
Based on client’s requirements and Filing Strategy
Modular & Bespoke PC Programs for flexibility and Speed
High-Throughput Technologies including Ambr® system
Supported by robust analytics
CQA (Critical Quality Attributes) Identification
FMEA (Failure Modes & Effects Analyses)
Analytical method qualification
Scale Down Models
DoE (Design of Experiment) Studies
Intermediate & Media Stability Studies
Support to definition of Program’s Validation Strategy
Process Performance Qualification (PPQ) Runs
Analytical assays Validation
Commercial-ready facility
Andelyn Partners with Ultragenyx on AAV Commercial Manufacturing
Following FDA approval for MPS IIIA, Andelyn Biosciences is manufacturing Ultragenyx’s Fayuvi™ for commercial supply in Columbus, Ohio. This marks the first FDA-approved gene therapy produced using the Andelyn AAV Curator® Platform.
Frequently Asked Questions
Dive into the story of Andelyn, where our journey from humble beginnings to a leader in cell and gene therapy development unfolds. Our history is not just a record of our past, but a testament to our enduring commitment to pioneering solutions for the most challenging medical needs. Learn about our legacy and how we are advancing discoveries today.
What does GMP mean in viral vector manufacturing?
GMP (Good Manufacturing Practice) defines the quality system and controls required to produce safe, pure, and potent viral vectors consistently. In GMP viral vector manufacturing, this includes qualified facilities, trained personnel, validated equipment and computerized systems, documented viral vector process development, and controlled operations from raw materials through release and distribution.
Why is GMP important for viral vector production?
GMP protects patient safety and product integrity by minimizing contamination, mix-ups, and variability. For a cell and gene therapy CDMO and an AAV manufacturing CDMO, adhering to GMP viral vector manufacturing standards ensures reproducibility across clinical and commercial batches, supports regulatory submissions, and enables reliable supply for trials and market.
What are the key regulatory requirements for GMP viral vector manufacturing?
Key requirements include quality management systems, change control, deviation/CAPA, data integrity, validated processes and analytical methods, environmental monitoring, raw material qualification, batch records, and release testing aligned to ICH, FDA, and EU guidelines. As a cell and gene therapy CDMO, we implement these controls from viral vector process development through PPQ.
How is viral vector quality controlled under GMP?
Under GMP viral vector manufacturing, quality control uses phase-appropriate, validated assays to measure identity, potency, purity, and safety (e.g., titer, full-to-empty ratio, residuals, sterility, mycoplasma, endotoxin, and adventitious agents). Trending, reference standards, and stability programs link viral vector process development to ongoing commercial control at an AAV manufacturing CDMO.
What are common manufacturing platforms for GMP viral vectors?
Common platforms include suspension bioreactors (e.g., STR50–STR2000) using HEK293 or Sf9 systems and adherent systems using HYPERStack vessels. Both platforms support GMP viral vector manufacturing, with platform selection driven by yield, scalability, and product CQAs, and supported by data-driven viral vector process development at a specialized AAV manufacturing CDMO.