CALIGOS
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Contact
28 rue des harengs
44230 Saint Sébastien Sur Loire
France
Gérante - Consultante Expert
About us
Making Quality your company's DNA Our know-how is based on strong expertise in Quality and project management, and our ability to listen to our customers' needs and propose solutions tailored to their context in terms of deadlines, quality and costs.
Business offer
CALIGOS currently supports biomanufacturers in:
- Setting up, managing or improving their quality management system: training/accreditation, documentation management, deviation management, etc.
- Pre- or post-audit/inspection support
- Support in digitalising their business: LIMS, EDMS, tracking systems, ERP, CRM, etc.
- Monitoring standards, comparing requirements, creating action plans, etc. - Carrying out risk analyses
- Carrying out annual product reviews, management reviews, etc.
- Carrying out internal or external audits (suppliers, subcontractors)
- Qualifying their systems in accordance with quality requirements (production and control equipment, automated/computerised systems, utilities)
- Validating their processes
Activities
- Service
- Other
- CMC
- GLP compliance
- GLP compliance
- Bioproduction
- GLP compliance
- GMP compliance
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Batch release
- Storage matter
- Instruction
- Logistic
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- Shear/shaking
- Viscosity
- Photostability
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Host cell proteins
- Viral clearance
- Contaminants detection
- Biosafety & Bioanalysis
- Toxicology
- PK/PD features
- Impurities detection
- Bioproduction analytical test
- Monitoring
- Characterization
- Batch consistency
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
- CMC/analytical quality assessment, quality control
- Cleaning
- Cross contamination
- Sterility
- Deviations
- Contaminants detection
- Safety for gene-edited cells
- translocation
- anti-nuclease response
- cytokine-independent growth
- Bioproduction engineering
- CGMP
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Automated high throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells
- Translocation
- anti-nuclease response
- cytokine-independent growth
- CMC
- GLP compliance
- for preclinical NCS (non-clinical safety) studies
- viral safety testing
- GMP compliance
- Quality control & analytical process monitoring
- Stability Assessment
- Biosafety & Bioanalysis
- Toxicology
- Immune response characterization
- Viral safety
- Bioproduction analytical monitoring
- Key and critical process parameters (KCP, CPP)
- Identification
- Monitoring
- Batch release test
- Chemical, physical, biological testing
- Potency assay
- Challenge animal models
- Impurities detection
- Quality control test support
