Ȩ > Manufacturing > м

  • Ȯ, е, ŷڼ ȭ
  • USP ICH Guideline Ȯ, е, /, ѵ ѵ

  • Bulk product(Ǵ drug substance)

Ǿǰ ȿⰣ, Ȯ

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  • ؤõ

  • HVAC(Air) Monitoring
  • Water(PW, WFI) Monitoring
  • Gases(Compressed Air, N2, CO2, O2) Monitoring

԰Ǵ 翡 ռ

Ȯν
Western Blot Host Cell Protein Amino acid content
Iso Electric Focusing Host DNA SEC-HPLC assay
SDS-PAGE Endotoxin Test RP-HPLC assay
(յ)BBL Crystal ̻ ѵ() GC assay
(յ)MIS ̻ ѵ(Ư)  
Amino Acid Mycoplasma Test  
Capillary Electrophoresis Sterility Test  
Peptide Mapping SEC-HPLC Assay  
N-terminal sequencing RP-HPLC Assay  
C-terminal sequencing HPLC Assay  
HPLC assay GC Assay  
GC assay SDS-PAG  
  Enzyme Immuno Assay  
  Cell-based Bioassay  
Ϲݽ
Appearance Test pH Test Particulate Matter ҿ뼺̸ڽ
UV SIT FT-IR Identification Test Optical Rotation
Water Content
ܹ н ߱ݼӽ() ߱ݼӽ(AA)
߽ ϼ( ϼ(HPLC) ǿ뷮
* Ϲݽ迡 ؼ Method Validation .

ܹ Ư м

÷ м õ м/Ͽ츦 , ִ Ǿǰ ߿ ʼ One-stop м ܹ Ưм񽺸
з ׸
Ȯ Molecular mass, Peptide mass fingerprinting, Charge variant, Disulfide bond, N & C-term sequencing
м N-Glycan, O-Glycan, PEGylation, Oxidation, Deamination
Aggregation, Fragmentation
Ҽ Host cell protein