Designing Flexibility & Compliance: Our Approach to a Complex Mabs, ADC & CAR-T Facility

Excited to share a milestone project from our team at AUSTAR! We’ve successfully delivered the Front-End Engineering & Consulting for a cutting-edge, multi-product biopharmaceutical facility. This project perfectly encapsulates our mission: transforming innovative science into manufacturable reality.

Project Background：

Our client is a forward-thinking biotech dedicated to developing next-generation immuno-oncology therapies. Their ambitious pipeline includes Monoclonal Antibodies (Mabs), Antibody-Drug Conjugates (ADC), and CAR-T cell therapies – a true representation of modern, targeted cancer treatment modalities.

The Challenge? To design a single, cohesive facility that could safely and flexibly manufacture these diverse and potent products, each with its own stringent GMP and biosafety requirements, all within a 24,000 m² greenfield shell building.

We provided the foundational GMP design for the entire facility, including:

• Mabs & ADC Production Areas

• CAR-T Cell Processing Suites

• Plasmid & Viral Vector Production (critical for cell therapy)

• QC Laboratories, Warehouse, & Central Utilities

Key Challenges & Our Strategic Solutions:

•  Biosafety & Containment: CAR-T and viral vector operations required strict BSL-2 compliance. Our design incorporated differential pressure cascades, dedicated air handling with HEPA filtration, and safe effluent management to protect both product and personnel.

•  Multi-Product Flexibility: Designing for shared use between antibody and CAR-T lines demanded a risk-based approach to facility layout. We implemented strict unidirectional personnel and material flows, segregated airlocks, and cleanroom zoning to prevent cross-contamination and ensure operational agility.

•  Potent Compound Safety (ADC): The ADC line required specific containment strategies for cytotoxic handling. We integrated closed processing, isolator technology, and detailed procedures for safe manufacturing.

•  Regulatory Foundation: The design was built from the ground up to meet FDA, EMA, and WHO standards, creating a robust framework for our client's future regulatory submissions.

Why This Matters:

This project is more than just drawings and specifications. It's the engineering backbone that will accelerate our client's path from clinical trials to commercial supply, ultimately helping bring vital new treatments to patients faster.

Here are our core capabilities:
•  End-to-End Expertise: From conceptual GMP strategy to detailed engineering.
•  Standards-Based Execution: Proven experience with global regulatory benchmarks.
•  Complex Problem-Solving: Tailoring technical solutions for the most advanced therapeutic modalities.

Proud of our team for delivering a design that balances innovation with pragmatism and safety with speed. We are committed to being the engineering partner of choice for biotech aiming to scale and succeed.