Services

Monitoring Microbial Contaminants

• Detection of aerobic/anaerobic bacteria, yeasts, molds
• Endotoxin level quantification (LAL assays)
• Batch-to-batch microbial purity validation

Microbial Isolation and Screening

• Isolation from fecal, soil, or fermented samples
• Functional screening: adhesion, immunomodulation, pathogen inhibition
• Exclusion of pathogenic or non-compliant strains

Microbial Identification

• 16S rRNA or ITS sequencing
• MALDI-TOF MS microbial fingerprinting
• Whole genome sequencing for novel strain registration

Microbial Stabilization

• Freeze-drying or cryopreservation
• Protective excipient screening (e.g., trehalose, skim milk)
• Viability tracking during accelerated stability testing

QC Analytical Testing

• CFU enumeration
• Morphology and gram-staining
• Growth kinetics and metabolite profiling

Specific Primers and Probes Design

• Strain-specific qPCR assay development
• Digital PCR quantification
• Fluorescent probes for in situ hybridization

Dissolution Testing and Drug Release Profiling

• In vitro digestion simulation (pH 1.5–8.0)
• USP apparatus I/II compatibility
• Kinetic modeling of probiotic release

Pre-formulation Capabilities Analysis

• Particle size and moisture content
• Surface charge (zeta potential)
• Compatibility with excipients

Final Product Assays

• Potency (CFU/g or CFU/capsule)
• Capsule integrity (disintegration time)
• Residual solvents or contaminants

Stability Test

• Accelerated and real-time studies
• Monitors viability and potency over time
• Required for IND and product approval

Microbial Formulation

• Lyophilization process design and optimization
• Stability strategy and shelf-life testing
• Biomass isolation and purification

Delivery Vehicle Development

• Alginate beads and pectin coatings
• Enteric capsules
• Colon-targeted release systems

Functional Screening and Mechanism of Action

Using advanced immunological and epithelial models, we assess anti-inflammatory potential, pathogen inhibition, and metabolic modulation to elucidate therapeutic mechanisms.

Host-Microbe Interaction Tests

Co-culture systems, 3D organoids, and transwell assays reveal the bidirectional interactions between LBPs and host cells, including barrier reinforcement and cytokine signaling.

Monocyte Activation Test

We measure CD14, CD80, IL-6, and TNF-α secretion to assess the immune activation potential of LBPs in primary human monocytes or THP-1 cells.

In Vitro Tests of Immune System Modulation

We evaluate the effects of LBPs on dendritic cells, macrophages, and T cells by quantifying surface marker expression, cytokine release, and cell polarization profiles.

Stress Response Profiling

By subjecting strains to bile salts, low pH, and oxidative agents, we determine their resilience and survival capacity in gastrointestinal environments or manufacturing stress.

Carbohydrate Fermentative Profiles

Phenotypic microarray and HPLC-based assays determine the strain's ability to utilize various prebiotic substrates and produce SCFAs, supporting synbiotic design.

Bioburden Testing

We measure the total viable count of aerobic and anaerobic bacteria, yeasts, and molds to ensure compliance with USP, EP, and JP standards during production and packaging.

Lab-scale Production

Using controlled fermenters (1–10 L), we produce research-grade material with defined growth parameters to optimize yield, viability, and metabolite output.

Microbial Fermentation

Strain-specific fermentation process development includes medium optimization, oxygenation control, and biomass harvesting strategies to achieve high-density cultures.

Downstream Process Development

We optimize downstream workflows such as centrifugation, filtration, concentration, cryoprotectant addition, and lyophilization for scalable and consistent LBP production.

In-process Assay

Real-time testing during manufacturing monitors CFU, pH, residual nutrients, and metabolite levels to ensure process control and batch reproducibility.

Biological Safety Test

• Cytotoxicity (MTT, LDH) assays
• Genotoxicity (Ames, comet) evaluations
• Regulatory-compliant biosafety package

Antifungal Activity Testing

• Agar diffusion and broth dilution methods
• Evaluates antifungal potential or safety
• MIC testing for formulation impact

Antimicrobial Susceptibility Testing

• MIC or disk diffusion per CLSI
• Profiles antibiotic resistance risk
• Supports strain safety documentation

Potency Test

• Functional readouts (e.g., cytokine modulation)
• Quantitative response curves
• Confirms biological activity retention

One-stop Solutions for Escherichia coli Nissle 1917

From genomic verification and safety assessment to formulation and in vivo validation, we offer an end-to-end development service for this FDA GRAS-certified probiotic strain.

Gene Integration Stability Test

We use qPCR, Southern blotting, and whole-genome sequencing to verify long-term gene expression stability in recombinant LBPs over multiple generations.

Zebrafish Models

Zebrafish larvae enable real-time assessment of LBP-induced toxicity, gut colonization, and immune responses using transparent, cost-effective, and genetically tractable in vivo models.