Analytical Development

From first titer reading to post-market surveillance—every assay validated, every data point audit-traced.

Reliable biomanufacturing lives or dies on analytics, yet too many programs bolt on “final” methods only after a process is locked. Aquaterra reverses that workflow. Our Analytical Development team engages at the clone-screening stage, building orthogonal assays in parallel with upstream and downstream optimization so every critical quality attribute (CQA) is measured—and controlled—long before engineering runs begin.

Each new method is born inside a digital-first lab: instruments stream time-stamped, Part 11-compliant data to a central historian where raw chromatograms, mass spectra, and qPCR traces link directly to batch, lot, and operator metadata. A built-in ALCOA++ framework means no manual re-entry, no shadow spreadsheets, and no “lost” data when regulators call.

The lab itself is platform-agnostic:

  • UHPLC systems equipped with MS, FLD, ELSD, and DAD detectors sit beside MALDI-TOF and LC-MS/MS for intact-mass confirmation.
  • Our molecular biology suite handles qPCR, ddPCR, and next-generation sequencing.
  • For biologics we round out the toolkit with CE-SDS, icIEF, and surface-plasmon resonance.
  • For food and alt-protein clients we offer rheology, texture, and sensory profiling tied to biochemical readouts.

Every assay advances through a gated lifecycle—design, qualification, validation, transfer—anchored to ICH Q14 and the draft Q2(R2) guidelines, ensuring the data you generate today slots cleanly into tomorrow’s BLA, MAA, or Novel Food dossier.

Quick Facts

  • 40+ platform methods (UHPLC, LC-MS/MS, qPCR, ddPCR, CE-SDS, icIEF, SPR)
  • ICH Q2(R2) & USP <1220> validation packages in ≤ 6 weeks
  • 24/7 LIMS with ALCOA++ audit trails and live deviation alerts
  • ≤ 5 % RSD across 120-sample precision runs (historic mean)
  • Integrated rheology & sensory suites for alt-protein texture mapping

Integrated Workflow

  1. Assay Design & Feasibility
    Select detection mode, dynamic range, and QC checkpoints; draft system-suitability parameters.
  2. Qualification & Range Setting
    Evaluate accuracy, precision, LoD/LoQ; establish preliminary acceptance criteria.
  3. Full Validation (ICH Q2/Q14)
    Robustness, specificity, linearity, and forced-degradation studies locked in ≤ 6 weeks.
  4. Method Transfer & Training
    Comparative runs between dev and GMP labs; pass/fail criteria ≤ 2 % bias.
  5. Lifecycle Management
    Continued-process verification trending, change-control assessments, and periodic re-validation.

Why Aquaterra?

  • Data Integrity by Design – Automated raw-data capture eliminates transcription errors and regulator headaches.
  • Orthogonal Depth – Multiple detection modes cross-verify CQAs, boosting confidence in out-of-spec decisions.
  • Speed to Validation – Draft Q2(R2) alignment compresses validation timelines to six weeks or less.
  • Regulatory Fluency – Each method dossier drops straight into CTD Module 3.2.S/P or Novel Food filings.

Next Step
Need assays that keep pace with your process and satisfy every agency?
Email info@aquaterrabiotech.com to discuss.