From first clone to commercial lot, our platform unites every discipline required to turn a microbe-based concept into a regulated product. High-density fermentation scales seamlessly from benchtop reactors to 40 k L stainless systems, while parallel cell-line engineering, data-driven process development, and real-time analytics accelerate optimisation and de-risk scale-up.

Downstream, automated purification trains, advanced formulation options, and aseptic fill-finish deliver material that meets global quality standards. Integrated tech-transfer programs, digital QMS, and regulatory authorship ensure each batch moves forward with cGMP rigour and audit-ready data—so one contract carries your asset from proof-of-concept to market with speed, consistency, and confidence.

Microbial Fermentation

High-density bioprocessing from shake flask to pilot and commercial scale:

• Batch, fed-batch, and continuous modes in stainless-steel bioreactors (1 L → 2,000 L pilot; up to 40,000 L commercial).
• DoE-optimized media and multi-sensor control for real-time feed strategies.
• Endotoxin ≤ 0.1 EU/mg and tight batch-to-batch titer consistency.

Cell Line Development

Strains and clones engineered for maximum yield and genomic stability:

• CRISPR/Cas9, Cas12a, and Golden-Gate libraries in E. coli, Pichia, and other microbes.
• AI-guided high-throughput screening (96 → 1,536 clones per run).
• Genomic stability and copy-number QC completed in ≤ 1 month.

Process Development

From proof-of-concept to pilot data packages:

• Scale-down models (1–5 L) matched to critical process parameters (CPPs) and CQAs.
• Advanced DoE and multivariate analytics to map design space.
• Integrated PAT (Raman, capacitance, FTIR) for rapid iteration.

Analytical Development

Data integrity from first assay to post-market:

• UHPLC, LC-MS/MS, glycan mapping, qPCR, NGS, endotoxin testing.
• Method validation/verification per ICH Q2(R2) draft & USP <1220>.
• 24/7 LIMS with ALCOA++ audit trails and live deviation alerts.

Downstream Purification

Purity, potency, and throughput—without compromise:

• Clarification, depth filtration, and TFF up to 1,000 L/h.
• Automated multicolumn capture/polish (Protein A, IEX, HIC, SEC).
• Spray-drying, freeze-drying, or aseptic bulk fill to 0.22 µm.

Formulation & Fill-Finish

Bulk drug substance to patient-ready product:

• Liquid vials, frozen bags (–80 °C), lyophilized cakes, spray-dried powders.
• Isolator-based aseptic fill with ± 1 % in-line mass-flow accuracy.
• Cold-chain validation to IATA/WHO standards with GPS lane mapping.

Tech Transfer & Scale-Up

Bench flask to 40 kL—seamless transition:

• Gap assessment, digital-twin modeling, and 2–5 L scale-down mimic.
• ≤ 8 weeks average lab-to-GMP onboarding for Phase I assets.
• < 5 % process-yield delta post-transfer (historic mean).

Quality & Regulatory Support

Audit-ready from day one:

• ISO 9001 & 13485 QMS; 100 % electronic batch records (21 CFR Part 11).
• IND/IMPD, GRAS, Novel Food, and BLA dossier authoring plus agency liaison.
• Mock PAIs, data-integrity drills, and CAPA closure in < 3 days (median).

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One contract. Gene-to-market certainty.
Reach us at info@aquaterrabiotech.com to schedule a capabilities walkthrough.