Hi all,
In the field of antibody, I hear a lot about orphan antibody. Are these orphan antibodies simply antibodies that exist but without purpose (e.g., no evident clinical benefits associated with them yet)?
Thanks
Can you specify your field more closely, or link to some examples?
I work in antibody engineering, but am not familiar with the term being consistently used.
I have seen it used for antibodies that have achieved "orphan drug" status, that is, therapeutic antibodies against diseases that are so rare that new therapeutic approaches get facilitated conditions for clinical trials (see https://journals.library.columbia.edu/index.php/stlr/article/view/3629/1455 )
It can also be used for antibodies generated by the company "Open Orphan" https://www.openorphan.com.
In analogy to orphan receptors, it could also be used for antibodies whose antigen is not known.
Can you specify your field more closely, or link to some examples?
I work in antibody engineering, but am not familiar with the term being consistently used.
I have seen it used for antibodies that have achieved "orphan drug" status, that is, therapeutic antibodies against diseases that are so rare that new therapeutic approaches get facilitated conditions for clinical trials (see https://journals.library.columbia.edu/index.php/stlr/article/view/3629/1455 )
It can also be used for antibodies generated by the company "Open Orphan" https://www.openorphan.com.
In analogy to orphan receptors, it could also be used for antibodies whose antigen is not known.
Guidance for Industry
Interpreting Sameness of
Monoclonal Antibody Products
Under the Orphan Drug
Regulations
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
or
Office of Orphan Products Development
Office of Special Medical Programs
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Phone: 301-796-8660; Fax:301-847-8621
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
So I guess you are most likely to encounter the first definition.
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