3. Human antigen triggered antibodies in rabbit
Used for acute organ rejection
Polyclonal antibodies kill array of lymphocytes
1980 – ATG – Anti - Thymo Globulin
Contraindicated in patients with history of allergy to rabbit
proteins or in case of having chronic infection etc. etc.
4. Human WBCs – T Lymphocyte
(Cell line)
Rabbit
Inoculation for Antibodies
Extraction & Purification
Antibodies (ATG) from Rabbit
Administration of ATG
to the Patient
5. Process Criticality
• Cell line ….
• Inoculation
• Extraction
• Purification
• Storage
• Dilution
• Filling
• Testing
Development and knowledge transfer to characterize process
protein and target globulin will be the first stone
6. Challenges
• Clean environment to avoid microbial
contamination in animal handling
• Aseptic extraction, purification &
filling process
• Protein characterization & testing