Viral Vector Services
Andelyn Biosciences collaborates closely with you throughout the entire development and commercialization process of your cell and gene therapies, from initial research and development to establishing a dependable clinical and commercial supply. With expertise in viral vector production, process optimization, and GMP manufacturing, we support you at every step, ensuring seamless development and manufacturing for your therapy.
GMP Viral Vector Manufacturing
Featuring 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.
GMP Scales
Andelyn Corporate Center
Step inside the Andelyn Corporate Center (ACC), our clinical and commercial production facility built for the rigors 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 other viral vectors, optimized for clinical trials and large-scale production. Discover how our facility reliably advances the path to market for life-saving gene therapy products through optimized and industrialized processes.
Late-Stage Capabilities for
Your Vector Program
Our GMP facility accommodates programs from Phase 1 to late-stage and commercial production, avoiding facility changes and tech transfers throughout the regulatory stages of your program journey.
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