Process Development

Aquaterra’s Process Development group turns bench protocols into reproducible GMP processes. We begin by building a living digital twin of your system—a kinetic model that mirrors oxygen transfer, shear, and residence time at every scale. With that in place, dozens of media and feed hypotheses are tested in silico before any raw material is touched. Top candidates then undergo 1 L confirmation runs in our closed, single-use bioreactors, streaming pH, DO, substrate concentration, and metabolite flux into a Part 11 historian at one-second resolution—creating a searchable audit trail from day one.

Classical one-factor-at-a-time approaches can take months; our DoE-driven engine compresses multi-variable optimization into weeks. We run 18–24 experiments in parallel micro-bioreactor blocks and feed results into multivariate algorithms that pinpoint true drivers of yield and quality. Once parameters converge, 5 L scale-down mimics—tuned for k<sub>La</sub> and shear within ± 5 %—validate scale-up equations. By the time your process reaches GMP-line engineering, every critical variable has been stress-tested, logged, and locked.

Quick Facts

  • Scale-Down Accuracy: 1–5 L reactors replicate production k<sub>La</sub> & shear within ± 5 %
  • Shake flask to 5 liter capacity
  • Rapid Design-Space Mapping: DoE + multivariate analytics cover CPP/CQA space in < 3 weeks
  • Robustness Challenges: 40-run stress sets completed in a single sprint; variance < 3 %
  • Inline PAT: Raman, FTIR (Live Model Prediction Control).

Integrated Workflow

  1. Feasibility & Baseline Mapping
    1 L runs fingerprint critical process parameters (CPPs) and quality attributes (CQAs).
  2. DoE Screening
    Orthogonal designs probe media, feed, pH, and DO; Bayesian optimizers propose confirmatory runs.
  3. Scale-Down Mimic
    5 L reactors tuned to production k<sub>La</sub>, shear, and residence time; results validate scale-up.
  4. Data Analytics & Control Strategy
    Multivariate models feed predictive PID loops; soft sensors hold substrates within ± 2 %.
  5. Tech-Transfer Dossier
    Process maps, control strategies, and validated ranges exported as CTD-ready documentation.

Why Aquaterra?

  • Iteration at Speed – DoE + AI analytics cut optimization cycles by 30 %.
  • PAT-First Philosophy – Real-time sensors shrink deviation risk long before GMP.
  • Proven Robustness – 40-run stress sets confirm process capability (C<sub>pk</sub> ≥ 1.33).
  • Regulator Ready – Every study generates Module 3 data you can drop straight into an IND or IMPD.

Next Step
Need a process that survives the jump to GMP scale without surprises?
Email info@aquaterrabiotech.com to book a scoping call or reserve development slots this quarter.