Seamless migration from bench flask to 40 kL—and every step in between. Aquaterra’s structured playbook, digital-twin modeling, and on-site process experts de-risk tech transfer while compressing your path to clinic and market.
Quick Facts
- Proven Expertise: Personnel who’ve executed multiple successful microbial and platform transfers
- Validated Volume Envelope: 5 mL → 40 kL across stainless-steel systems
- Rapid Onboarding: ≤ 8 weeks average lab-to-GMP for Phase I assets
- Yield Consistency: < 5 % process-yield delta post-transfer (historic mean)
- Quality System: ISO 9001 & 13485–certified tech-transfer QMS
- Data Integration: 24/7 historian & e-Batch-Record with real-time deviation alerts
- Predictive Modeling: DoE-driven scale-down models deliver ± 5 % accuracy on titer, purity, and CQAs
- Operation Library: Digital-twin simulator covering 10+ unit operations
Integrated Workflow
- Gap Assessment & Data Harvest
- Joint review of process descriptions, raw batch records, and analytical packages
- Establish CPPs, CQAs, and acceptable operating ranges
- Scale-Down & Digital Modeling
- 2–5 L bench mimics plus hybrid CFD/mass-transfer simulations to predict shear, k<sub>La</sub>, and nutrient gradients
- DoE screens in < 96 h to identify robustness windows before physical runs
- Lab-Pilot Bridging
- 50–200 L reactors mirror pilot downstream skid
- Inline Raman and capacitance probes feed historian; automated dashboards flag drift in real time
- cGMP Engineering Runs
- Two engineering batches at target commercial scale (200 L–2,000 L microbial)
- Full QC panel: host-cell protein, DNA, endotoxin, and glycan profiling to benchmark CQAs
- Process Performance Qualification (PPQ)
- Three consecutive PPQ batches with acceptance criteria per ICH Q11 and FDA Process Validation guidance
- Continuous improvement loop mines PAT data with AI to tighten control limits
- Regulatory & Knowledge Transfer
- IND/IMPD/BLA support: eCTD-ready Modules 3.2.S and 3.2.P
- Comprehensive tech-transfer dossier delivered into client QMS
- Lifecycle Scale-Up & Tech Refresh
- Capacity expansion planning for upstream/downstream systems with parallel train road-mapping
- Periodic tech reviews to align process with evolving pharmacopeia and platform upgrades
Why Aquaterra?
- Blueprint-Driven Consistency – Our “Transfer-Twelve” SOP library drives reproducibility across sites and campaigns
- Digital Twin Advantage – Proprietary hybrid models cut wet-run iterations by 40 %, saving weeks and material costs
- Cross-Functional SWAT Team – Upstream, DSP, formulation, QA, and regulatory experts work as one pod—no silos or delays
- Transparent Economics – Stage-gated pricing with clear deliverables keeps budgets predictable from feasibility to PPQ
- Regulatory Support – Dedicated guidance for global filings and agency interactions
One contract. Seamless scale-up. Gene-to-market certainty.
Email info@aquaterrabiotech.com to schedule your tech-transfer kickoff.