Upstream & Downstream Purifcation
End-to-end unit operations—from high-density fermentation through final polishing—delivered in cGMP suites that scale with you from IND through commercial launch.
Quick Facts
- Max Bioreactor Volume: 40 kL
- Controlled Harvest Chill: 10 → 15 °C
- Endotoxin Spec: ≤ 0.1 EU/mg
- Purity: ≥ 99.9 % by SDS-PAGE
- Real-Time Control: 24/7 PAT data streaming
- Cleanrooms: ISO 14644-5 Grade C
Integrated Workflow
- High-Density Fermentation
Batch, fed-batch, or continuous runs in stainless-steel systems up to 40 kL; Raman soft sensors drive closed-loop DO, pH, and feed control. - Primary Recovery
Disc-stack centrifugation, depth filtration, and continuous floc clarification remove > 95 % biomass while preserving shear-sensitive proteins. - Chromatography Platform
Automated multi-column capture (Protein A, IEX, MMC) and polishing (HIC, SEC) skids deliver reproducible, scalable purity. - Ultrafiltration/Diafiltration
TFF cassettes (1–100 kDa) concentrate product with inline buffer exchange—rapid, PAT-driven formulation in a single step. - Fill-Finish or Bulk Storage
Aseptic filling (vials, pre-filled syringes) or –80 °C bulk storage, supported by ICH-guided stability programs.
Why Aquaterra?
Regulatory-First Mindset – IND- and BLA-ready documentation with on-site QA yields fewer agency questions and faster approvals.fication
Single Partner, Full Stack – One PO covers fermentation, purification, and fill-finish, compressing timelines by 30 %.
PAT-Driven Efficiency – Real-time analytics reduce batch-to-batch variability below 5 % and de-risk tech transfer.