TUSTIN FACILITY Manufacturing, Built to Deliver
Clinical and commercial biologics manufacturing with scalable infrastructure, validated processes, and a proven path to long-term supply.
manufacturing
Where Development Becomes Delivery
Avid’s Tustin facility is designed for the transition from development into reliable, large-scale manufacturing.
Supporting clinical and commercial production, this site provides the infrastructure, quality systems, and operational expertise
required to consistently deliver biologic therapies.
EXPLORE THE FACILITY
Interactive Walkthrough
Explore Tustin’s manufacturing suites, equipment, and process environments.
Each area is designed to support a specific stage of CGMP manufacturing, from
upstream production through downstream purification and final drug substance release.
TUSTIN MANUFACTURING
Infrastructure, Quality and Operational Expertise
Upstream Manufacturing
Scalable biologics production: Single-use bioreactor systems support clinical and commercial manufacturing at scale, with infrastructure designed for consistent, reproducible performance. Processes developed upstream are executed here under controlled, validated conditions.
Downstream Manufacturing
Purification aligned with product quality: Chromatography and filtration systems support robust purification processes, ensuring product purity and consistency across manufacturing campaigns.
Process Validation (PPQ)
Built for regulatory approval: Process performance qualification (PPQ) campaigns demonstrate consistent manufacturing performance, supporting BLA submission and regulatory approval.
CGMP Manufacturing Suites
Controlled environments, consistent execution: Manufacturing suites are designed to meet CGMP standards, supporting clinical and commercial production with full documentation, traceability, and control.
Analytical & Quality Labs
Testing that supports every batch: On-site analytical labs support in-process testing, release testing, and stability studies, ensuring every batch meets defined specifications.
Drug Substance Processing
End-to-end manufacturing: From cell culture through purification and bulk drug substance production, Tustin supports complete manufacturing campaigns within one facility.
Support Systems & Utilities
Infrastructure behind the process: Dedicated utilities, controlled systems, and facility engineering support reliable, uninterrupted manufacturing operations.
BUILT FOR CLINICAL AND COMMERCIAL SCALE
From First Batch to
Long-Term Supply
Tustin supports manufacturing across all stages:
- Phase I–III clinical production
- Process validation (PPQ)
- Commercial manufacturing campaigns
- Ongoing supply and lifecycle management
Infrastructure is designed to scale with your program, supporting consistent execution as demand grows.
Development
Connected to Development
Development work from Costa Mesa transitions directly into Tustin manufacturing, maintaining continuity of process, analytical methods, and team knowledge.
This connection supports efficient scale-up and consistent execution from early development through commercial production.
CAPABILITIES
Explore Related Capabilities
Manufacturing you can rely on
Explore the facility or connect with our team to plan your clinical or commercial
manufacturing strategy.
Learn More
Facility FAQs
Process validation, or process performance qualification (PPQ), demonstrates that a manufacturing process consistently produces product meeting predefined quality specifications.
A biologics manufacturing facility produces drug substances using living cells under controlled, CGMP conditions for clinical and commercial use.
Current Good Manufacturing Practice (CGMP) ensures products are consistently produced and controlled according to quality standards required by regulatory agencies.
Yes. The facility supports Phase I–III production, process validation, and commercial supply.
Processes developed at Avid transition directly into Tustin manufacturing, maintaining continuity and supporting efficient scale-up.
