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Biotechnology / Immune system / Pharmacology / Monoclonal antibodies / Biologic / Cell culture / Hybridoma technology / Center for Biologics Evaluation and Research / Humanized antibody / Biology / Immunology / Medicine


PTC in Manufacture and Testing of Monoclonal Antibody Products for Human Use
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City

Rockville / /

Company

Recombinant DNA Technology / mAb / /

Continent

North America / /

/

Event

FDA Phase / /

Facility

Laboratory Animals / Rockville Pike / /

IndustryTerm

cell bank / vector banking procedures / individual products / manufacturing changes / ancillary products / cellular products / biologics license applications / controlled food sources / animal supplier / cell culture systems / to human products / biotechnology-derived drugs / downstream product / culture media / expression systems / manufacturing / hybridoma and heterohybridoma generated products / transient expression systems / monoclonal antibody products / food / /

MedicalCondition

tumor / lymphoma / strain / zoonoses / infectious diseases / infectious pathogens / infection / infectious agents / /

MedicalTreatment

immunization / /

Organization

U. S. Department of Health and Human Services / National Institute of Health / Food and Drug Administration Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration Subject / Food and Drug Administration / office of Establishment Licensing and Product Surveillance / WCB / D. ADMINISTRATION OF RADIOLABELED ANTIBODIES / office of Therapeutics Research / office of Communication / Training / and Manufacturers Assistance / /

Person

Kathryn C. Zoon / Sharon Carayiannis / /

/

Position

Director / PRODUCT MANUFACTURE AND TESTING A. GENERAL / /

Product

Biologicals / New Drug / /

ProvinceOrState

Maryland / Indiana / /

PublishedMedium

the NIH Guide / /

Technology

Pharmacokinetics / phage display / ANTIBODIES / biotechnology / cloning / pharmacodynamics / stem cells / drug development / /

URL

http /

SocialTag