High-Potency API Production: AUSTAR's API Modular in CDMO Partnership

In today's competitive pharmaceutical landscape, CDMOs face dual challenges: delivering flexible, scalable production while ensuring uncompromising compliance with EHS and cGMP standards. Recently, AUSTAR partnered with a leading pharmaceutical enterprise to deploy our modular API manufacturing system for high-potency APIs (HPAPIs) requiring OEB5 containment. This project exemplifies how modular innovation bridges cutting-edge engineering with real-world operational excellence.

The Challenge: Process Requirement and Occupational Safety

The client needed a turnkey solution to produce high-value oncology APIs under stringent conditions:
? Handling highly toxic API with occupational exposure risks

? Meeting global cGMP standards across 50L–400L scales

? Accelerating time-to-market for CDMO contracts

Traditional facilities posed risks of cross-contamination, lengthy validation, and inflexible upgrades.

AUSTAR's API Modular

We delivered an integrated system combining GMP-compliant hardware with full-cycle validation services, featuring:

1. Containment-Centric Design
     ? Closed charging isolation systems and laminar flow hoods ensured operator safety during OEB5 processes.

     ? Material-specific reactor modules (glass-lined, Hastelloy) accommodated diverse synthesis pathways.

2. Plug-and-Play Efficiency
     ? Pre-commissioned dissolution, triple-layer filtration (0.45μm + 0.22μm x2), and crystallization units reduced onsite installation by 40%.

     ? CIP/SIP systems enabled rapid batch changeovers—critical for CDMO multi-product flexibility.

3. Intelligent Process Control
     ? Real-time pressure monitoring and VFD-driven pumps optimized crystallization kinetics.

     ? Self-contained carbon adsorption eliminated impurities without external exchangers.

Results: Rapid Response to Process Requirement & Project

? 10% Faster commissioning duration: Modular offsite validation cut commissioning time versus traditional builds.

? Zero Regulatory Observations: Closed-system design and non-PUPSIT filter testing streamlined FDA/EU audits.

? Scalability Built-In: The "Lego" style layout allows continuous capacity expansion as CDMO demand grows.

Why Global Leaders Choose AUSTAR
? Risk Mitigation: 20+ years of modular deployments across 20 countries.

? Cost Transparency: 30% lower lifecycle costs via reduced footprint and maintenance.

? Future-Proof Flexibility: Adaptable designs for emerging modalities like ADCs and peptides.