Viral Vector Manufacturing
Andelyn Biosciences collaborates closely with you throughout the entire
development 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.
GMP Viral Vector Manufacturing
Featuring Andelyn platforms for tech transfer, semi-automated fill and finish, cell
culture capabilities, experienced MSAT team, 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 lentiviral vectors, optimized for clinical trials and commercial scale. Discover how our facility reliably advances the path to market for life-saving gene therapy products through optimized 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 during clinical stages.
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