Metric Ton-Scale cGMP Facility
Commercial API manufacturing at scale.
Purpose-built for large-volume production, Phlow’s Metric Ton facility delivers 50–100 metric tons annually using advanced batch and continuous manufacturing modes—with production redundancies and multi-product campaign flexibility.
Dual Independent Process Trains
Two independent reactor and isolation trains within a single building. Production redundancies enable multi-product campaign scheduling and continuity without cross-contamination risk.
Multi-Ton Annual Capacity
Up to 50–100 metric tons API per year, process dependent. Right-sized for commercial launch volumes, established products, and sustained market supply.
Up to 50–100 metric tons API per year, process dependent. Right-sized for commercial launch volumes, established products, and sustained market supply.
Large-Scale Reactor Infrastructure
Four reactors per train: 1,000 gal (3,785 L) and 2,000 gal (7,570 L) vessels in Hastelloy and glass-lined steel. Custom 2,000 gal Hastelloy filter reactor for integrated reaction and filtration.
Four reactors per train: 1,000 gal (3,785 L) and 2,000 gal (7,570 L) vessels in Hastelloy and glass-lined steel. Custom 2,000 gal Hastelloy filter reactor for integrated reaction and filtration.
Advanced Batch & Continuous Manufacturing
Process flexibility across batch, continuous flow, and hybrid architectures. Multiple high-throughput production lines enable campaign-based scheduling for diverse product portfolios.
Process flexibility across batch, continuous flow, and hybrid architectures. Multiple high-throughput production lines enable campaign-based scheduling for diverse product portfolios.
Right-sized manufacturing for complex molecules.
The Metric Ton facility is designed for sponsors that need:
- Commercial launch volumes for new molecular entities entering the market
- Sustained supply for established products with steady demand
- Multi-product manufacturing under a single cGMP facility with segregated process trains
- Production continuity through redundant equipment and campaign-based scheduling
Isolation and drying equipment are sized to meet full annual production capacity, ensuring no downstream bottlenecks limit throughput.
Dual Independent Process Trains
The facility operates two independent reactor and isolation trains within a single building:
The facility operates two independent reactor and isolation trains within a single building:
- Complete process segregation from raw material dispensing through final isolation and drying
- Campaign-based scheduling allows multiple API programs without equipment reconfiguration
- Production redundancy: if one train requires maintenance or cleaning validation, the second remains operational
Each train includes:
- Dedicated solids and liquids dispensing booths
- Four-reactor synthetic sequence capability
- Independent filtration and solids handling systems
Reactor Configuration
Four reactors per train:
Four reactors per train:
- 1,000 gallon (3,785 L) reactors
- 2,000 gallon (7,570 L) reactors
- Materials of construction: Hastelloy (corrosion-resistant) and glass-lined steel
Custom 2,000 gallon Hastelloy filter reactor:
- Integrated reaction and filtration in a single vessel
- Eliminates transfer steps and reduces cycle time for filtration-intensive processes
- Purpose-designed for high-throughput commercial campaigns
Isolation & Drying Systems
Sized to meet full annual production capacity with no downstream bottlenecks:
Sized to meet full annual production capacity with no downstream bottlenecks:
- Filter dryer: Continuous filtration and drying for heat-sensitive APIs
- Conical dryer: Efficient solvent removal with gentle agitation
- Inverting basket centrifuge: High-throughput solid-liquid separation for crystalline products
Scale & Throughput Specifications
Annual Capacity
Up to 50–100 metric tons API, process dependent. Actual capacity determined by:
Up to 50–100 metric tons API, process dependent. Actual capacity determined by:
- Number of synthetic steps and cycle time per step
- Isolation and drying requirements
- Campaign frequency and changeover time
- Analytical release testing schedules
Production Model
Multipurpose, campaign-based manufacturing:
Multipurpose, campaign-based manufacturing:
- Single-product campaigns with full equipment dedication during the campaign
- Validated cleaning procedures between product changeovers
- Multi-product scheduling enabled by dual independent trains
Process Modes
- Advanced batch synthesis: Traditional stirred-tank reactors for well-characterized, scalable processes
- Continuous manufacturing: Integration of flow reactors for hazardous or high-throughput steps
- Hybrid architectures: Batch synthesis with continuous flow-enabled steps inserted where safety, selectivity, or throughput demands continuous processing
Multi-Product Campaign Flexibility
Production Continuity Through Redundancy
The dual-train configuration provides:
The dual-train configuration provides:
Uninterrupted supply: One train can remain operational during scheduled maintenance or cleaning validation of the other
Multi-product capability: Different API programs can be scheduled in sequence without facility downtime
Risk mitigation: Equipment failures or deviations in one train do not halt all production
When Metric Ton-Scale is Optimal
The Metric Ton facility is purpose-built for programs where:
The Metric Ton facility is purpose-built for programs where:
Commercial volumes are required: Phase III clinical trials through full market supply
Market demand is established: Products with predictable, sustained annual demand
Lifecycle stability matters: Long-term supply agreements require production continuity and redundancy
Economies of scale apply: Cost-per-kilogram benefits from large batch sizes and efficient throughput
Petersburg Campus Integration
The Petersburg campus houses two distinct cGMP manufacturing facilities—the Kilo-Scale Facility for clinical and early commercial programs, and the Metric Ton-Scale Facility for large commercial API production—both operating under a single, site-wide quality management system aligned with U.S. FDA cGMP requirements. Programs developed in Phlow’s Richmond laboratories scale up at Petersburg under uniform quality standards and a shared regulatory framework, with continuous technical team involvement from process development through commercial production. This integrated model eliminates the friction, delays, and tech transfer risk typically associated with multi-site CDMO handoffs.
Quality & Regulatory Framework
Phlow operates under a comprehensive quality management system aligned with U.S. FDA cGMP requirements for API manufacturing. Quality oversight spans development, scale-up, and commercial production, ensuring:
- Consistent documentation and data integrity across the product lifecycle
- Process validation packages suitable for regulatory submission
- Change control and deviation management aligned with ICH guidelines
- Ongoing lifecycle management and post-approval change support
Regulatory Support for Sponsor Submissions
Phlow supports sponsor regulatory submissions through:
- Robust CMC documentation packages (Module 3 content for CTD submissions)
- Process validation reports and analytical method validation
- DMF (Drug Master File) filings for commercial programs
- Regulatory continuity from IND through NDA/ANDA and post-approval lifecycle management
API manufactured at the Petersburg campus is suitable for:
- Phase III clinical trial material
- NDA/ANDA filings for U.S. commercial products
- International regulatory submissions (EMA, Health Canada, Japan PMDA, etc.)
- Post-approval commercial supply with ongoing regulatory support
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