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Science &
Technology
Regulatory
Advancement
Emerging
Threats
Strategic
Management
Obaid Ali, Ph.D.
Lead Strategic Office of Science & Technology
DRAP, Islamabad, Karachi, 05 Mar 2024
Antithymocyte Globulin
From Human Antigen to Rabbit Antibody
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.
Human WBCs – T Lymphocyte
(Cell line)
Rabbit
Inoculation for Antibodies
Extraction & Purification
Antibodies (ATG) from Rabbit
Administration of ATG
to the Patient
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
Challenges
• Clean environment to avoid microbial
contamination in animal handling
• Aseptic extraction, purification &
filling process
• Protein characterization & testing
Thanks
Obaid Ali, Ph.D.
Lead Strategic Office of Science & Technology
DRAP, Islamabad, Karachi, 05 Mar 2024

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