Commercial API manufacturing with scale flexibility.
Dual cGMP Manufacturing Suites
Two independent cGMP suites (~4,000 sq. ft. each) with containment booths. 24 support tanks across suites enable complex multi-step synthesis with staging flexibility and process segregation.
Hybrid process execution: batch, flow, or combined architectures. Up to 100 L synthesis scale with process-dependent flexibility to match your molecule’s optimal manufacturing strategy.
0.3–3 kg/day throughput depending on process complexity. Up to ~250 kg API annual capacity (process dependent). Right-sized for Phase I/II clinical supply or niche commercial programs.
Integrated non-GMP lab for flow and batch process optimization. Seamless transition from development to GMP production under one roof—no external tech transfer required.
Right-sized manufacturing for complex molecules.
Phlow’s Kilo facility bridges the gap between lab-scale development and large-volume commercial manufacturing. For programs that require:
- Clinical trial material (Phase I/II) and low-volume API manufacturing
- Initial commercial launch volumes for specialty or orphan drug products
- Complex, multi-step syntheses where smaller batch sizes reduce risk
- Lifecycle management for mature products with modest demand
…the Kilo facility provides cGMP-compliant manufacturing without the capital intensity or minimum order quantities of large-scale production.
Each suite spans approximately 4,000 square feet and includes:
- Two containment booths per suite for high-potency API handling
- Independent HVAC and environmental controls for process segregation
- Six support tanks per containment hood (24 total across facility)
- Designed for batch synthesis up to 100 L, process-dependent
24 support tanks enable:
- Multi-step synthetic sequences with intermediate staging
- Solvent and reagent feeds for continuous or semi-continuous operations
- Process flexibility for complex reaction cascades
Dedicated suite for:
- Process optimization and troubleshooting during scale-up
- Flow chemistry development and hybrid process design
- Scale-down studies to support deviation investigations or process improvements
- Direct line of sight between development and manufacturing teams
Scale & Throughput Specifications
Up to 100 L synthesis capacity, process-dependent. Actual batch size determined by:
- Reaction energetics and heat transfer requirements
- Solvent volumes and concentration limits
- Containment needs for high-potency compounds
0.3–3 kg/day, depending on:
- Number of synthetic steps
- Cycle time per step (reaction time + workup/isolation)
- Analytical release testing requirements
- Campaign scheduling and changeover time
Up to ~250 kg API (process dependent). Suitable for:
- Multi-year clinical trial supply for Phase I/II programs
- Commercial launch quantities for specialty therapeutics
- Orphan drug or limited-market products
- Lifecycle management for established APIs with stable, modest demand
Process Flexibility: Batch, Flow & Hybrid Manufacturing
The Kilo facility is purpose-built for programs where:
The facility supports:
This flexibility allows process design to follow chemistry—not infrastructure constraints.
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:
- IND submissions (Investigational New Drug applications)
- Clinical trial material (Phase I, II, III)
- NDA/ANDA filings for U.S. commercial products
- International regulatory submissions (EMA, Health Canada, Japan PMDA, etc.)
Ready to advance your API program?
Start the Conversation
Partner with Phlow for US-based small molecule API development and manufacturing.
Start the Conversation