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Deamidation / Proteins / Liquid chromatography–mass spectrometry / Lysergic acid diethylamide / Peptide / Amino acid / Monoclonal antibodies / Asparagine / Posttranslational modification / Chemistry / Biology / Chromatography


ICH GCG ASEAN Training Workshop - ICH Q5C[removed]May[removed]Case studies Case study 1 Stability issues: “Catastrophin”
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Document Date: 2012-06-21 12:42:48


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Company

IgG / Case / /

Currency

EUR / /

Event

Product Issues / Product Recall / /

Facility

terminal Asp / N terminal / /

IndustryTerm

grey bromobutyl rubber stopper/ / manufacturing site / rubber / drug product / treatment of cancer / biological medicinal product / clear and colourless isotonic solution / stability protocol / bromobutyl rubber tip cap / /

MedicalCondition

leukaemia / cancer / flu / Sterility / MS / influenza / /

MusicGroup

pI / /

Person

CDC ADCC / Stability Test Interval (Months) / ELISA ADCC / /

Position

Major / representative / /

Product

dose / schedule / /

ProgrammingLanguage

C / /

Technology

stability protocol / antibodies / recombinant DNA technology / /

SocialTag