Viability engineered. Efficacy delivered. Manufacturing you can trust.

Aquaterra Biotech is an independent, science-driven CDMO in Québec, Canada. We build probiotic programs that survive the real world—fermentors, fill lines, warehouses, trucks, kitchens, stomachs—without compromising on quality, documentation, or cost discipline. If you’re scaling Lactobacillus, Bifidobacterium, spore-formers like Bacillus, next-gen anaerobes, or designer synbiotics and postbiotics, our platform turns fragile biology into reliable product. One contract. One digital thread. From strain selection to shelf-life claims and global logistics.

Why Aquaterra for Probiotics

We treat “live” like a critical quality attribute, not a hope.
Probiotic success isn’t just CFU at harvest; it’s verified viability at the end of shelf life, after shipping, in real consumer conditions. Aquaterra builds that certainty into each unit operation and proves it with analytics, stability, and documentation that stand up to retailers and regulators.

Our edge, in brief:

• End-to-end integration: Upstream → downstream → stabilization → formulation → packaging → distribution. No hand-offs, no data gaps.
• Anaerobe expertise: True low-O₂ handling with engineered lines, deoxygenated media, and oxygen-scavenging packaging.
• Stabilization by design: Cryoprotectant and microencapsulation platforms tailored to strain physiology and target use-case.
• Regulatory fluency: GRAS/Novel Food dossiers, structure/function substantiation, and international labeling/compliance.
• Cost intelligence: Real COGS drivers surfaced early—media, utilities, excipients, packaging, cold chain—to make phase-appropriate decisions.

Scope of Services

1) Strain Onboarding & Manufacturability Assessment

We start with the truth: not every strain is manufacturable at scale without modification. Our manufacturability review quantifies:

• Growth kinetics (µmax), acid and bile tolerance, osmotic stress response
• Oxygen sensitivity profile and redox requirements
• Cell morphology and aggregation behavior impacting clarification/concentration
• Intrinsic freeze/heat tolerance and protective solute repertoire
• Genetic stability across passages, plasmid maintenance (if relevant), and prophage risk

Deliverable: A go/no-go and optimization plan covering media design, bioreactor mode (batch/fed-batch/continuous), unit ops, and stabilization hypotheses—mapped to timelines, costs, and risk.

2) Media & Process Development (UP)

We use DOE and response-surface modeling to tune carbon/nitrogen sources, buffers, micronutrients, and growth promoters while managing acid load and redox. For strict anaerobes, we implement:

• Pre-reduced media with controlled redox potentials
• Gas overlays (N₂/CO₂) with inline dissolved oxygen < 1 ppm
• Low-shear agitation and impeller geometry that preserves cell integrity
• Automated pH/DO/ORP control; off-gas analysis for respiratory monitoring

We scale from 1–5 L screens to 30–50 L development runs and pilot-GMP stainless (300–2,000 L), modeling kLa, mixing time, and heat removal so you don’t learn expensive lessons at volume.

3) Harvest, Clarification & Concentration (DSP)

We stabilize viability during the most dangerous minutes of a probiotic’s life: coming off the fermentor.

• Temperature discipline: Rapid cool-down with jacket/ HX to arrest metabolic damage.
• Clarification: Gentle centrifugation or depth filtration, tuned to morphology and EPS content.
• Concentration/Diafiltration: Low-shear TFF with pore size and TMP optimized to CFU recovery; conductive diafiltration to exchange into cryoprotectant buffers without osmotic shock.

4) Stabilization Platforms

Freeze-drying (lyophilization):

• Cryoprotectant screens (trehalose, sucrose, skim-milk matrices, amino acids, polymers) using micro-lyo plates and DTA to define collapse temperature (Tc) and glass transition (Tg’).
• Cycle design that limits ice crystal injury and reconstitution lag.
• Post-lyo residual moisture targeting 1.5–3.5% depending on strain/package.

Spray-drying / Fluid-bed:

• For heat-tolerant strains or spores, we deploy inlet/outlet temperature corridors and protective shells (proteins/polysaccharides) to preserve viability with excellent flow properties and scalability.

Microencapsulation:

• Alginate, pectin, chitosan, lipid systems; mono- and multi-layer coatings for acid and bile resistance; bead size tailored to format (capsule, sachet, beverage).
• Encapsulation improves gastric survival without overdosing CFU at fill—efficacy and cost meet.

Postbiotics:
If your program is moving toward inactivated cells (paraprobiotics) or cell-free metabolites, we design thermal/pressure/UV inactivation validated by residual DNA/protein assays and retain bioactivity through targeted fractionation.

5) Formulation & Formats

We formulate to the life your product will live:

• Capsules & tablets: Flow agents, disintegrants, and moisture buffers that protect CFU without compromising dissolution.
• Sachets & sticks: Particle engineering for uniformity; flavors/sweeteners that don’t kill cells over time.
• Beverages & dairy analogs: pH, dissolved oxygen, preservative systems, and shear exposure co-designed with your co-packer’s line.
• Synbiotics: Prebiotic selection (FOS, inulin, GOS, resistant starch) compatible with strain metabolism and sensory targets.
• Topicals & pet health: Osmolality and preservative strategy aligned to viability and label claims.

6) Packaging & Oxygen/Moisture Control

We build packaging into stability, not after it:

• High-barrier films/bottles (foil laminates, HDPE with barrier liners)
• Desiccants and O₂ absorbers sized by headspace and ingress models
• Nitrogen flushing and low-O₂ capping; torque validation for seal integrity
• Unit cartons engineered to shipping/stacking realities; ISTA-compliant testing

7) Analytics, Stability, and Release

We measure what matters:

• Viable counts: ISO-aligned plating, flow cytometry with viability dyes, rapid qPCR for ID with PMA/EMA to distinguish live/dead signal when needed.
• Impurities & safety: Residual solvents, heavy metals, allergens, mycotoxins, and microbial limits (pathogen absence).
• Function: Acid/bile tolerance, adhesion surrogates, antimicrobial activity, metabolite fingerprints (SCFAs, postbiotic profiles).
• Stability: Real-time and accelerated (25 °C/60% RH; 30 °C/65% RH; 40 °C/75% RH), open-and-close studies, shipping simulation.
• Label claim validation: Modeled CFU over shelf life with confidence intervals; we design your overage scientifically, not by guesswork.

Release package includes: Methods/SOPs, CoA, batch genealogy in LIMS, deviation reports, change control, and data summaries fit for retailer audits and international submissions.

8) Regulatory & Claims Support

• GRAS/Novel Food dossiers: Safety narrative, manufacturing description, specifications, allergen, and toxicology assessment.
• Structure/function claims: Evidence hierarchies, literature synthesis, and post-market surveillance plans.
• International labeling: CFU declaration conventions, strain naming, allergen labeling, and health-claim boundaries across regions.
• Quality frameworks: HACCP plans, ISO 22000/13485 alignment paths; pharma-adjacent GMP where programs need it.

9) Manufacturing & Tech Transfer

Pilot → commercial without reinvention:

• Stainless-steel pilot GMP (300–2,000 L), with validated clean-in-place and segregation for food- vs. pharma-grade areas.
• Single-use trains where risk and speed justify it.
• Tech-transfer binders with full BOMs, MBRs, CCPs, hold-time studies, and stability windows for every intermediate.
• Scale-out to partner facilities in NA, EU, APAC when you’re ready—same package, same outcome.

Specialty Domains

Strict Anaerobes & Next-Gen Consortia

We run true anaerobe lines with deoxygenated media, inert gas headspace control, and oxygen-scrubbing packaging—plus real-time ORP monitoring and dissolved oxygen analytics that actually stay near zero. For multi-strain products, we balance growth kinetics and competitive interactions with staggered fermentation and proportional blending to hit CFU ratios lot-to-lot.

Spore-Formers for Resilience

Bacillus programs leverage high-density sporulation, heat-resistant stabilization, and aggressive moisture control for ambient storage and rugged shipping. We verify spore counts, germination profiles, and safety (enterotoxin absence) in release.

Microencapsulation for Targeted Delivery

We build bi-layer and tri-layer systems (e.g., alginate core with chitosan or lipid shell) optimized for gastric resistance and small-intestine release, modeled against dissolution and diffusion tests. It’s how we raise on-target CFU without ballooning dose size or cost.

Postbiotics & Paraprobiotics

When consistency, safety, or IP strategy favors non-viable approaches, we extract, fractionate, and stabilize metabolite-rich supernatants or inactivated cells—backed by functional assays (cytokine modulation, barrier integrity) and clean specifications.

Digital Twin, QA, and Cost Intelligence

Open-architecture collaboration:
A secure digital twin exposes live process data—fermentor trends, TFF parameters, in-process CFU—so sponsors and auditors can see what we see. IP is protected in a SOC-2–certified environment; your models train on your data, not anyone else’s.

Quality without drama:
Right-first-time documentation, deviation dashboards, and change control keep lots moving and inspections calm. We build audit-ready trails by default—because probiotic claims get scrutinized.

COGS transparency:
Our project dashboards decompose media costs, utilities (steam, chillers, compressed gas), lyophilization/spray-drying energy, excipients, packaging, labor, and depreciation. You can decide, with numbers, whether microencapsulation beats overage, or whether ambient distribution offsets higher unit-cost packaging. Clarity is a competitive advantage.

Sustainability by design:
Life-cycle accounting (ISO 14064) baked in; renewable-power PPAs offset ~90% of site electricity. We quantify the footprint benefits of ambient vs. cold-chain strategies and help you tell an honest ESG story.

Representative Pathways

A. Women’s health synbiotic

• Lactobacillus + prebiotic blend; microencapsulated core, enteric protection, desiccant-optimized HDPE bottle.
• Stability: 24 months at 25 °C with <0.2 log/month decline; claims maintained with modest overage.
• Retailer audit: pass on first review with full method validation and open-and-close data.

B. Spore-based shelf-stable gut support

• High-titer Bacillus sporulation; spray-dry; sachet format with high-barrier laminate and oxygen absorber.
• Ambient distribution globally; label claim maintained at 30 °C/65% RH.

C. Next-gen anaerobe for metabolic health

• Strict anaerobe with engineered media; nitrogen-blanketed processing and O₂-scrubbing packaging.
• Freeze-dry with trehalose/amino acid matrix; 12-month stability at 4–8 °C; controlled international roll-out.

D. Postbiotic for skin barrier

• Cell-free fraction enriched for target metabolites; thermal inactivation, microfiltration, and fractionation.
• Cosmetic-grade specs; stability in formula; claims strategy built on in-vitro and clinical-adjacent evidence.

Probiotics FAQ

How do you size overage responsibly?
By modeling decay from real-time/accelerated stability and using confidence bounds. We combine Arrhenius-type extrapolations with packaging ingress models to hit label claims without waste.

Can we ship ambient?
For spores and some robust lactics—yes, with the right barrier and desiccant. We generate data under 25–30–40 °C profiles and recommend worst-case packaging that clears your distribution map.

What about oxygen-sensitive strains?
We take a systems view: low-O₂ processing, scavenging packaging, and matrix chemistry that shields cells. If your marketing requires clear bottles and daily opening, we’ll show you what that costs in overage.

How do you ensure multi-strain ratios hold?
Staggered fermentations, proportional blending, and stability-driven ratio adjustments. We reject lots that drift outside spec—process control, not hope, keeps ratios true.

Program Onboarding (30 Days)

Week 0–1: Strain dossier intake, manufacturability assessment, draft CQA/CMP list
Week 2: DOE design for media/protectants; packaging path hypotheses
Week 3: Bench runs + mini-lyo/spray-dry screens; preliminary stability start
Week 4: Go/no-go + Phase Plan (UP/DSP, stabilization, format, packaging, analytics), with budget and Gantt

From there, we move through pilot campaigns with pre-set gate criteria. You’ll always know where your batch—and your budget—stands.

The Aquaterra Difference

• Live is a CQA. We instrument it, design for it, and defend it with data.
• Manufacturability first. If it scales on paper but dies in the warehouse, it isn’t “done.”
• Open by default. Your digital twin mirrors our floor; surprises die in daylight.
• Sustainability that counts. Real energy/carbon numbers, not slogans.
• Regulatory calm. Dossiers that move through review because they read like they were written by the reviewer.

Let’s Build a Probiotic That Deserves the Label

Whether you’re launching a retail synbiotic, scaling a spore-based ambient product, developing strict anaerobes for next-gen indications, or pivoting to postbiotics, Aquaterra Biotech turns complexity into certainty. From strain to ship-to-door, we make viability predictable—and audit-ready.

Visit us in Montréal to tour our facility and review live stability dashboards.

Email our team: info@aquaterrabiotech.com