This discussion is fairly long and detailed. It starts on Page 76 if anyone wants to read the whole thing.
----------------------------------------------------------
Dr. Beigel described recent NIAID involvement with IV immunoglobulin (IVIG); the timeline from concept to product (GLP IVIG) was 4.5 years (SARS study).
Plasma collection and development of IVIG are not as rapid as people think. Some steps could be optimized. The use of source plasma as the therapeutic could improve the timeline by 6–12 months, but you sacrifice some scientific benefits.
The timeline for developing monoclonal antibodies can reach 3–4 years. Dr. Beigel noted recent studies suggesting antibody isolation may be decreased from 6–12 months to 28 days, though this study was specifically looking at vaccines and not convalescent subjects. He said the time for monoclonal antibody engineering could be reduced from the current 6–12 months.
Investigators are working to reduce the time to develop master cell lines from 12 months to 6 months. The time for manufacturing and release would stay the same. So while the timeline can be improved, it is still unlikely that monoclonal antibodies could be developed rapidly enough (with current technologies and approval processes) for emerging infectious diseases.
Dr. Beigel concluded that passive antibody is an option for emerging infectious diseases, but it is labor-intensive. Plasma collection and IVIG development is not as rapid as assumed, but it’s still faster than de novo drug development. In the best-case-scenario, plasma could be available in 3 months, and IVIG in 7–12 months. Monoclonal antibodies are promising for emerging infectious diseases but would require some leaps in timeframes.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf
----------------------------------------------------------
Dr. Beigel described recent NIAID involvement with IV immunoglobulin (IVIG); the timeline from concept to product (GLP IVIG) was 4.5 years (SARS study).
Plasma collection and development of IVIG are not as rapid as people think. Some steps could be optimized. The use of source plasma as the therapeutic could improve the timeline by 6–12 months, but you sacrifice some scientific benefits.
The timeline for developing monoclonal antibodies can reach 3–4 years. Dr. Beigel noted recent studies suggesting antibody isolation may be decreased from 6–12 months to 28 days, though this study was specifically looking at vaccines and not convalescent subjects. He said the time for monoclonal antibody engineering could be reduced from the current 6–12 months.
Investigators are working to reduce the time to develop master cell lines from 12 months to 6 months. The time for manufacturing and release would stay the same. So while the timeline can be improved, it is still unlikely that monoclonal antibodies could be developed rapidly enough (with current technologies and approval processes) for emerging infectious diseases.
Dr. Beigel concluded that passive antibody is an option for emerging infectious diseases, but it is labor-intensive. Plasma collection and IVIG development is not as rapid as assumed, but it’s still faster than de novo drug development. In the best-case-scenario, plasma could be available in 3 months, and IVIG in 7–12 months. Monoclonal antibodies are promising for emerging infectious diseases but would require some leaps in timeframes.
http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf