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.

75+ INDs
Approved
Multiple Decades
of Gene therapy Manufacturing
450+ cGMP
Clinical Batches
PPQs
Material Generated Supporting BLA
250k
Combined Square Feet of Facility Space

GMP Scales

Suspension cGMP Manufacturing equipment
Adherent cGMP Manufacturing equipment

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.

Explore the Facility

High-Throughput Approach for Research and Toxicology Grade Vector Production

Suspension Processes

Standard Suspension Scales

RG and TOX Grade Productions

  • STR50 Bioreactor
  • STR200 Bioreactor
  • Enhanced Documentation (TOX)
  • Enhanced Testing (TOX)
Adherent Processes

Standard Adherent Preps

  • HYPERStack® Cell Culture Vessels
  • 5HS to 30HS (GMP sublot scale)
  • Enhanced Documentation (TOX)
  • GMP Grade Materials (TOX)
  • Enhanced Testing (TOX)

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)

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Andelyn’s Approach

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

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Key Activities

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

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Validation

Support to definition of Program’s Validation Strategy

Process Performance Qualification (PPQ) Runs

Analytical assays Validation

Commercial ready facility

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