Transforming Peptide API Manufacturing
Introducing FLOWSMART™ by SP2TX
FLOWSMART™ redefines peptide synthesis by solving what current methods can't — scale, automation, and ESG readiness in one platform. This revolutionary system represents a paradigm shift in pharmaceutical manufacturing, combining unprecedented efficiency with environmental responsibility.
Designed specifically for large-scale production of therapeutic peptides, FLOWSMART™ addresses the critical bottlenecks that have historically limited peptide API manufacturing, offering pharmaceutical companies a clear path to commercial-scale production.
Where the Industry Stands Today
SPPS in Batch Reactors
Traditional solid-phase peptide synthesis using batch reactors. While established and widely understood, this method struggles with heat/mass transfer issues and scaling limitations.
Hybrid
Combines batch processing with liquid-phase peptide synthesis (LPPS). Offers improvements over pure SPPS but introduces complex integration challenges when scaling up.
Flow Chemistry
Employs microfluidic systems for continuous processing. While promising for small-scale operations, fundamental constraints in backpressure limit commercial viability.
These established methods each present unique advantages that BI is thoroughly familiar with. However, they all encounter significant bottlenecks when attempting to scale beyond pilot production, limiting their commercial viability for long-acting peptides.
Technology Bottlenecks at Scale
Each platform encounters a fundamental limitation when transitioning from laboratory to commercial production. These aren't merely engineering challenges but represent physical, operational, or economic barriers that cannot be overcome through simple optimization.
The constraints are particularly pronounced when synthesizing longer peptides (30+ amino acids), where reaction kinetics and purification complexity increase exponentially with peptide length. This creates a technological ceiling that has historically limited the commercial viability of many therapeutic peptide candidates.
Operational Pain Points
Facility Throughput Bottlenecks
Current systems create production chokepoints that significantly limit overall facility capacity and flexibility.
Complex Cleaning Validation
Multi-component systems require extensive, time-consuming cleaning validation protocols between production runs.
Low Purification Yields
Batch-to-batch variability results in inconsistent purification outcomes and suboptimal overall yields.
Site-Specific Tech Transfer
Moving production between facilities requires extensive revalidation and often results in unpredictable outcomes.
Beyond technological limitations, traditional peptide synthesis systems introduce significant operational friction that impacts production timelines, resource allocation, and global manufacturing strategies. These pain points frequently result in 18–24 month scale-up delays, creating substantial opportunity costs and market timing challenges.
FLOWSMART™: Engineered for Commercial Scale
Commercial Production
1,000+ kg/year capacity
Process Integration
Automated synthesis and inline QC
Sustainability
85% solvent recovery, DMF-free
FLOWSMART™ represents the first peptide synthesis platform specifically architected for large-scale GMP production of therapeutic peptides. Unlike systems that were adapted from laboratory techniques, FLOWSMART™'s fundamental design principles address commercial manufacturing requirements from inception.
By reimagining the synthesis process through the lens of commercial viability, FLOWSMART™ eliminates the compromises inherent in traditional approaches. The platform delivers unprecedented scalability while maintaining synthesis integrity, even for challenging long-acting peptides that have historically been difficult to manufacture efficiently.
What FLOWSMART™ Solves That Others Can't
Superior Yields
Achieves 40–45% crude yield even for complex peptides exceeding 30 amino acids in length, approximately doubling the efficiency of traditional methods.
Full Automation
End-to-end automation from synthesis through inline quality control minimizes human intervention and dramatically reduces variability between production runs.
Modular Scaling
Proprietary column architecture enables simple capacity expansion beyond 1,000 kg/year while maintaining consistent process parameters.
Low Pressure Operation
Revolutionary <2 bar operating pressure eliminates the flow constraints that have traditionally limited continuous flow chemistry approaches to peptide synthesis.
Environmental Leadership
85% solvent recovery and complete elimination of DMF significantly reduce environmental impact while improving operator safety.
Global Deployment
Standardized, modular design ensures consistent performance across manufacturing sites with minimal site-specific adaptation.
Legacy Problems → FLOWSMART™ Solutions
Weeks of synthesis
Traditional peptide synthesis requires weeks of processing time, creating production bottlenecks and limiting responsive manufacturing.
< 24h full cycle
FLOWSMART™ completes entire synthesis cycles in less than 24 hours, dramatically improving throughput and manufacturing responsiveness.
High solvent use
Conventional methods consume massive solvent volumes with poor recovery, creating environmental concerns and disposal challenges.
Green solvents + 85% recovery
FLOWSMART™ employs environmentally responsible solvents with industry-leading 85% recovery rates, dramatically reducing waste.
FLOWSMART™ transforms the peptide manufacturing landscape by directly addressing the fundamental limitations of legacy systems. Its revolutionary approach doesn't just incrementally improve existing processes – it reimagines them from first principles to deliver breakthrough performance.
The Engineering That Makes It Possible
Low-Pressure Resin Technology
FLOWSMART™'s proprietary resin formulation enables high-efficiency coupling reactions while maintaining minimal backpressure, even at commercial flow rates. This revolutionary material science breakthrough eliminates the fundamental scaling limitation of traditional flow chemistry.
Multi-Zone Heating Innovation
Precise temperature control across multiple reaction zones ensures optimal reaction kinetics throughout the synthesis process. This advanced thermal management system maintains ideal conditions even as scale increases, preserving yield and purity.
Scale-Invariant Design
FLOWSMART™'s fundamental architecture maintains a stable surface-to-volume ratio regardless of production scale. This engineering breakthrough ensures that laboratory-optimized processes translate directly to commercial production without requiring extensive reparameterization.
Unlike traditional Vapourtec systems that encounter limiting backpressure at scale or batch processes with poor heat and mass transfer, FLOWSMART™'s innovative engineering maintains optimal reaction conditions throughout the synthesis process, regardless of scale.
FLOWSMART™ vs. Hybrid: Efficiency & Cost
Crude Yield
40-45% vs Hybrid's 20-25%
Synthesis Time
<24 hours vs Hybrid's 2-4 weeks
CapEx (100kg/yr)
$30-40M vs Hybrid's $90-120M
FTEs per batch
2-3 vs Hybrid's 6-8
When directly compared to Hybrid systems like those employed by Lilly, FLOWSMART™ demonstrates transformative advantages across every key performance metric. The dramatic improvements in yield, synthesis time, and capital requirements combine to create a compelling economic case for FLOWSMART™ adoption.
The operational efficiencies extend beyond direct costs, with FLOWSMART™ requiring significantly fewer full-time employees per production batch due to its comprehensive automation capabilities. This staffing efficiency translates to lower operating costs and reduced training requirements.
Faster Global Tech Transfers
Standardized Modules
Identical process modules ensure consistent performance across all global manufacturing sites.
Minimal Revalidation
Standardized systems dramatically reduce site-specific validation requirements and documentation effort.
Rapid Deployment
3-6 month rollout versus traditional 18-30 month technology transfer timeline.
Flexible Production Network
Easy activation of backup production sites ensures manufacturing continuity and risk mitigation.
FLOWSMART™'s modular architecture fundamentally transforms the technology transfer process for BI's global manufacturing network. By standardizing the core production technology across all sites, FLOWSMART™ eliminates the variability that has historically complicated multi-site peptide production.
This standardization enables BI to rapidly deploy production capabilities to Ingelheim, Ridgefield, Shanghai, or other facilities with minimal site-specific adaptation. The resulting manufacturing flexibility provides strategic advantages in supply chain resilience, regional market access, and production risk management.
ESG & Sustainability Leadership
FLOWSMART™ establishes new industry benchmarks for environmental sustainability in peptide API manufacturing. Its revolutionary solvent recovery system captures and purifies 85% of process solvents, dramatically reducing the Process Mass Intensity (PMI) compared to both traditional batch and hybrid approaches.
Beyond solvent recovery, FLOWSMART™ eliminates hazardous DMF/NMP solvents in favor of more environmentally responsible DMSO and ethyl acetate. The system's energy consumption is 30-50% lower than conventional methods, while its compact design reduces facility footprint by approximately 50%, further enhancing sustainability credentials and reducing construction costs.
Co-Building the Future with BI
CIP-Ready Modules
Designed for seamless integration with BI's Clean-in-Place systems and manufacturing infrastructure.
Peptide Flexibility
Compatible with unoptimized peptides like BI 3034701 without requiring extensive sequence adaptation.
ESG Alignment
Sustainability metrics and validation documentation aligned with BI's environmental and regulatory systems.
Global Deployment
Ideal for standardized implementation across BI's international manufacturing network.
FLOWSMART™ has been specifically engineered to align with BI's strategic manufacturing objectives and infrastructure. Rather than requiring BI to adapt to a rigid technology platform, FLOWSMART™ offers a tailored solution that complements existing systems while delivering transformative capabilities.
This alignment extends to peptide compatibility, with FLOWSMART™ demonstrating exceptional performance even with challenging sequences like BI 3034701. The platform's flexible architecture accommodates the full range of BI's peptide pipeline without requiring extensive sequence optimization or manufacturing compromises.
Collaboration Proposal
Pilot-Scale Synthesis (0-3 months)
Demonstration of FLOWSMART™ capabilities using BI-selected peptide sequences. Validation of yield, purity, and process parameters under observation by BI technical team.
Deliverables: Analytical data package, crude product samples, preliminary process parameters
Joint Feasibility Study (3-5 months)
Collaborative evaluation of integration requirements, scale-up parameters, and validation approach. Economic modeling and ROI analysis specific to BI's manufacturing network and peptide pipeline.
Deliverables: Technical integration plan, economic analysis, regulatory strategy
Deployment Planning (6-12 months)
Detailed implementation roadmap including site selection, technology transfer timelines, and production validation strategy. Establishment of joint teams for seamless knowledge transfer and system optimization.
Deliverables: Master implementation plan, training protocols, performance metrics
Our proposed collaboration follows a structured, phased approach that minimizes risk while establishing clear value milestones. Each stage builds on validated results from previous phases, ensuring alignment between technical capabilities and BI's specific manufacturing requirements.
Let's Build Together
FLOWSMART™ isn't just a synthesis tool. It's a strategic capability that lets BI lead in peptide innovation — fast, globally, and sustainably. By transforming the fundamental economics and timelines of peptide manufacturing, FLOWSMART™ enables BI to pursue therapeutic opportunities that would be impractical with conventional technology.
Let's explore how to bring this to your pipeline — starting with the next molecule. Together, we can establish a new paradigm in peptide API manufacturing that combines unprecedented efficiency with environmental leadership and global scalability.
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