Naobios

Activities

Categories

• Service

Therapeutic applications

• Genetic Diseases
• Oncology
• Infectiology
• Immunology

Expertises

Gene and CAR-T cell therapy Directory

• 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
Prophylactic Vaccines Directory

• Bioproduction GMP
• Vaccine platform type
• Recombinant protein expression
• Synthetic Peptides or oligomers
• Virus-like particles (VLP) and nanoparticle-based carriers
• killed/inactivated virus
• Live attenuated virus
• Viral vector encoding target antigen
• DNA plasmid vaccine
• mRNA vaccine
• Lipid delivery vehicle
• Outer-membrane vesicles (OMV)
• Polysaccharides/ conjugated vaccines
• Other
• Pilot Batches scale
• Process development & optimization
• Scale-Up & Validation
• Comparability characterization protocol
• Manufacturing Volume
• Small volume (< 100 L) adjusted to phase I/II needs: specify volume
• Large volume (100 – 1000 L) adapted for phase III needs
• Final scale up volume (> 1000 L) and validation for manufacturing
• Commercial supply during life cycle management
• USP (Scale-Up)
• DSP (Recovery)
• 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