Polyclonal
Immunogen
Designing the Immunogen
Consideration for, Specifications
High dose activity & background
Adjuvent
Standard and proprietary adjuvant
Consideration for low background
Immunization protocol
Adjustment for high dose activity
Low background
Herd management
Development, selection &
maintenance of animals
Production
Methods:
Plasmapheresis
Classical bag bleed
Mg/Kg Scale Production
Demand/Supply Analysis
Stock management
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Monoclonal
Immunogen
Designing of the Immunogen
Consideration for Affinity, Avidity
Sensitivity and Cross reactivity
Development and production
Hybridoma development (in-house)
Production from in-house cell lines
Production from client’s cell lines
Pre-production verification
Cell banking:
Master, Working & Research
Cryopreservation
Production
Methods:
In-vitro
In-vivo
Mg/Kg Scale Production
Demand/Supply Analysis
Stock management
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Standards and controls
Sourcing of human serum/plasma
sourcing of analyte
Production of standards (as per customer specification)
Production of standards with multi analytes
Verification of analyte concentration
Packaging and labeling
Production
Methods:
Spiking
Mg/Kg Scale Production
Demand/Supply Analysis
Stock management
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