Page 3 - Pharmaceutical M5 Biopharma
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 ANALYTICAL WORKFLOW    Critical Quality
 Attributes (CQAs)


 Functional
 Discovery  Assays

 Intact Protein         Intact proteins: robust and reliable
 Analysis                 separation and measurement
 Cell Line  Cell   Protein A                                         4
  Screenin   Line  Purification  Glycan  Analysis  Glycans: addressin  both fast screenin    7
 Glycan
                                and full profilin
 DEVELOPMENTAL WORKFLOW  Optimization  Intermediates  Enzymatic  Mappin   Culture media: comprehensive analysis   10
 Prep
                      Peptides: in-depth characterization of
 Peptide
 Process
 Culture
                                primary structure
 Di estion
 Scale-up
                                                                     9
 Purification
 Media
                              made fast and easy



 Evaluation  Final  Analysis
 Formulation

 PK-PD
 Pre-Clinical /   Plasma   Bioanalysis: acceleratin  the
 nSMOL™
 Clincal Phase  Samples  Proteolysis  Bioanalysis  pre-clinical/clinical phase
                                                                    13


 Final               Impurities: investi ation of a  re ation
 Manufacture  Product  Controllin  Various  and more                16
  Impurities
 QA/QC
 Data Mana ement /   Total solution for re ulatory compliance       18
                                 and reportin
 Data Inte rity

                         Global Shimadzu Location List              19



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