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. Andelyn Biosciences supports you at every step.
GMP Viral Vector Manufacturing
Featuring Andelyn platforms or tech transfer, semi-automated fill and finish, experienced MSAT team, quality control, quality assurance and regulatory support.
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 construction and clean room technologies and GMP compliance enabling design and operations, the ACC is currently producing GMP and commercial-grade, high-quality viral vectors. Discover how our facility reliably advances the path to market for life-saving therapies.
Late-Stage Capabilities for
Your Vector Program
Our GMP facility can accommodate programs from Phase 1 to late-stage and commercial, 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