고마바이오텍(주)

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제품 상세

Antibody

6.5 - 270 kDa 범위를 커버하는 3가지 컬러 밴드를 포함하며,
최대 100%까지의 transfer 효과를 개런티하는 Prestained protein ladder를 소개합니다.

프린트 제품 문의

특징

  

  • Ready-to-use cell을 이용한 bioassay kit는 시판되는 바이오 치료제 또는 reference standard로 검증되어, 바이올로직스 치료제 개발에서 QC/Lot 출시에 이르기까지 모든 과정의 실험에서 쉽게 이용할 수 있습니다. 
  • Bioassay kit은 치료제의 임상에서의 작용 메커니즘 (MOA)을 반영하여 효능과 안정성을 입증하는데 효과적입니다.
  • 세포배양이 필요없는 ready-to-use cell을 제공하여 작업 오류를 줄이고 시간을 단축합니다. 
  • 또한 분석개발 및 검증시간을 단축하고 정확한 데이터를 제공하며 비용을 절감하고 단순화된 global method transfer가 가능하며, 궁극적으로 역가 테스트 및 QC lot 출시를 가속화합니다. 
  • 30개 이상의 바이오시밀러 표적에 대한 mechanism of action (MOA)-based assays 를 제공함으로써, assay 개발 시간을 최소 6개월 절약할 수 있습니다.
  • 손쉬운 분석 프토토콜은 24시간 이내에 신속한 결과를 제시하며, 중간에 washing 과정이 필요없습니다. 
  • 전세계 제약 및 CRO사에서 이용되고 있으며, APAC 및 EMA에서 시판되는 의약품의 Lot 출시에 사용됩니다. 



분석 종류

  • ADCP (Antibody- Dependent Cellular-Phagocytosis)
  • ADCC (Direct Target Cell Death)
  • cAMP Accumulation
  • β-Arrestin Recruitment
  • Receptor Dimerization
  • SH2 Recruitment
  • SHP Recruitment 등







적용

  • in vitro comparability testing
  • Characterization studies
  • Potency assay development
  • Quality control testing for lot release
  • Drug stability testing
  • Neutralizing antibody assays for immunogenicity screening



Bioassay Kit의 구성 

모든 bioassay kit은 최소 1,000 data points를 구할 수 있는 분량의 시약이 제공됩니다. 
  • 10 vials of frozen ready-to-assay cells
  • Detection Reagents
  • Cell Plating Reagent
  • Dilution Buffer
  • Control Ligand
  • 10 x 96-well Tissue Culture Treated Plates 


eurofins discoverx-bioassay kit



실험 과정

bioassay-kit-procedure



Bioassay Kit 종류


Qualified Bioassay

  • Biosimilar/ Biobetters Development Programs에 적합
  • 알려져 있는 특정 drug으로 테스트를 하여 성능을 입증하고 최적화한 bioassay kit 
  • Assay development timeline 최소 6개월 단축
  • HS (High Sensitivity) 버전은 variation을 낮추어 재현성을 향상

INN Drug Name Qualified With Molecular Mechanism
of Action		 Assay Measures Bioassay Kits Size
Rituximab - Cytotoxicity Direct Target Cell Death (ADCC) 97-1012Y026-00169 2-plate
97-1012Y026-00170 10-plate
Semaglutide Ozempic® GLP1R agonist cAMP Accumulation 95-0062Y2-00175 2-plate
95-0062Y2-00176 10-plate
Aflibercept Eylea® VEGF-Trap VEGFR2 (KDR) Dimerization 93-0996Y1-00153 2-plate
93-0996Y1-00154 10-plate
93-0996Y1-00005 2-plate
93-0996Y1-00006 10-plate
Bevacizumab Lucentis® Anti-VEGDA mAb VEGFR2 (KDR) Dimerization 93-0996Y1-00165 2-plate
93-0996Y1-00166 10-plate
93-0996Y1-00001 2-plate
93-0996Y1-00002 10-plate
Ranibizumab Avastin® Anti-VEGFA mAb VEGFR2 (KDR) Dimerization 93-0996Y1-00167 2-plate
93-0996Y1-00168 10-plate
93-0996Y1-00003 2-plate
93-0996Y1-00004 10-plate
Adalimumab Humira® Anti-TNFα mAb IkB Degradation 93-0538B15-00131 2-plate
93-0538B15-00132 10-plate
Anti-PD-1/PD-L1 Keytruda® PD-L1-induced PD-1 signaling SHP Recruitment 93-1104Y19-00117 2-plate
93-1104Y19-00118 10-plate
Tocilizumab Actemra® Anti-ligand (IL-6) or anti-receptor (IL-6RA) drugs Ligand-induced receptor dimerization (IL6RA/IL6ST) 93-1045B3-00109 2-plate
93-1045B3-00110 10-plate
Anakinra Kineret® IL-1RA (Inhibits IL-1) IL1R/IL1RAP Dimerization 93-1032Y3-00105 2-plate
93-1032Y3-00106 10-plate
Darbepoetin Alfa Aranesp® EPOR agonist EpoR/EpoR Dimerization 93-0965Y3-00019 2-plate
93-0965Y3-00020 10-plate
Epoetin Alfa Recombinant hEpo EPOR agonist EpoR/EpoR Dimerization 93-0965Y3-00017 2-plate
93-0965Y3-00018 10-plate
Exenatide Byetta® GLP1R agonist cAMP Accumulation 95-0062Y2-00101 2-plate
95-0062Y2-00102 10-plate
Liraglutide Victoza® GLP1R agonist cAMP Accumulation 95-0062Y2-00099 2-plate
95-0062Y2-00100 10-plate
Insulin Glargine USP Insulin INSRb agonist SH2 Recruitment 93-0466Y3-00011 2-plate
93-0466Y3-00012 10-plate
Insulin Lispro USP Insulin INSRb agonist SH2 Recruitment 93-0466Y3-00009 2-plate
93-0466Y3-00010 10-plate
Insulin USP Insulin INSRb agonist SH2 Recruitment 93-0466Y3-00007 2-plate
93-0466Y3-00008 10-plate
Parathyroid Hormone (PTH) Recombinant hPTH PTHR agonist β-Arrestin Recruitment 93-0315Y2-00047 2-plate
93-0315Y2-00048 10-plate
Panitumumab ‎Vectibix® Anti-EGFR mAb EGFR/ErbB2 Dimerization 93-1051Y3-00093 2-plate
93-1051Y3-00094 10-plate
Pertuzumab Perjeta® Anti-HER2-dimerization mAb ErbB2/ErbB3 Dimerization 93-1042Y3-00095 2-plate
93-1042Y3-00096 10-plate
Teriparatide ‎Forteo® PTHR agonist cAMP Accumulation 95-0118Y2-00057 2-plate
95-0118Y2-00058 10-plate
Somatotropin, Somatropin Recombinant hGH GHR agonist SH2 Recruitment 93-0756Y3-00023 2-plate
93-0756Y3-00024 10-plate
Follitropin alfa Gonal-F FSHR agonist cAMP Accumulation 95-0119Y2-00103 2-plate
95-0119Y2-00104 10-plate
Sargramostim Leukine® Recombinant GM-CSF (CSFR2 agonist) CSF2RB/CSF2R Dimerization 93-1078Y3-00111 2-plate
93-1078Y3-00112 10-plate

  

 

 

Target-Based Bioassay


  • Reference ligand로 테스트하여 최적화된 bioassay kit
  • 동일한 타겟이나 MOA를 참고함으로써 치료제의 잠재성 확인, 특성화, 중화항체 확인 등의 development program에 이용

 

 

Target Molecular Mechanism
of Action		 Assay Measures Bioassay Kits Size
CD19, CD20, CD38 Cytotoxicity Antibody- Dependent Cellular-Phagocytosis 97-1012Y026-00179 2-plate
97-1012Y026-00180 10-plate
IL7R/IL2RG IL-7R/IL-2RG Agonists Ligand-induced receptor (IL7R/IL2RG) Dimerization 93-0997Y13-00081 2-plate
93-0997Y13-00082 10-plate
IL1RL1/IL1RAP IL-1RL1/IL1RAP Antagonists Ligand-induced receptor (IL1RL1/IL1RAP) Dimerization 93-1067Y3-00079 2-plate
93-1067Y3-00080 10-plate
TrkA-p75 Agonist drugs SH2 Recruitment 93-0529Y3-00147 2-plate
93-0529Y3-00148 10-plate
MCHR1 Agonist drugs β-Arrestin Recruitment 93-0940Y3-00149 2-plate
93-0940Y3-00150 10-plate
GHSR Agonist drugs β-Arrestin Recruitment 93-0242Y3-00141 2-plate
93-0242Y3-00142 10-plate
LHCGR Agonist drugs cAMP Accumulation 95-0106Y2-00137 2-plate
95-0106Y2-00138 10-plate
MRGPRX2 Agonist drugs β-Arrestin Recruitment 93-0309Y2-00143 2-plate
93-0309Y2-00144 10-plate
AGTR1 AGTR1 Agonists β-Arrestin Recruitment 93-0312Y2-00125 2-plate
93-0312Y2-00126 10-plate
AGTRL1 AGTRL1 Agonists β-Arrestin Recruitment 93-0250Y2-00121 2-plate
93-0250Y2-00122 10-plate
BDKRB2 BDKRB2 Agonists β-Arrestin Recruitment 93-0189Y2-00113 2-plate
93-0189Y2-00114 10-plate
CNR1 CNR1 Agonists β-Arrestin Recruitment 93-0959Y2-00119 2-plate
93-0959Y2-00120 10-plate
C5AR1 anti-ligand (anti-C5a) β-Arrestin Recruitment 93-0557Y2-00059 2-plate
93-0557Y2-00060 10-plate
CCR2 antagonist drugs β-Arrestin Recruitment 93-0192Y2-00061 2-plate
93-0192Y2-00062 10-plate
CXCR5 antagonist drugs β-Arrestin Recruitment 93-0514Y2-00063 2-plate
93-0514Y2-00064 10-plate
Exendin-4 agonist drugs β-Arrestin Recruitment 93-0300Y2-00029 2-plate
93-0300Y2-00030 10-plate
FGFR4-β-Klotho agonist drugs SH2 Recruitment 93-1060Y3-00089 2-plate
93-1060Y3-00090 10-plate
GPBAR1 agonist drugs cAMP Accumulation 95-0049Y2-00139 2-plate
95-0049Y2-00140 10-plate
GLP1R agonist drugs β-Arrestin Recruitment 93-0300Y2-00027 2-plate
93-0300Y2-00028 10-plate
GLP2R agonist drugs β-Arrestin Recruitment 93-0572Y2-00133 2-plate
93-0572Y2-00134 10-plate
IGF1R agonist drugs SH2 Recruitment 93-0505Y1-00069 2-plate
93-0505Y1-00070 10-plate
IL2RB/IL2RG/IL2RA modified agonists; anti-IL2 drugs Ligand-Induced Receptor (IL2RB/IL2RG/IL2RA) Hetero-oligomerization  93-1003Y3-00091 2-plate
93-1003Y3-00092 10-plate
IL6R/IL6ST Anti-IL-6 mAbs Ligand-induced receptor (IL6RA/IL6ST) dimerization 93-1045Y3-00043 2-plate
93-1045Y3-00044 10-plate
IL10RA/IL10RB anti-receptor (IL-10RA) drugs Ligand-induced receptor dimerization (IL10RA/IL10RB) 93-0985Y3-00135 2-plate
93-0985Y3-00136 10-plate
IL17RA/IL17RC Anti-IL-17 mABs Ligand-induced receptor (IL17RC/IL17RC) Dimerization 93-0999Y3-00053 2-plate
93-0999Y3-00054 10-plate
IL31RA/OSMRb anti-ligand (IL-31); anti-receptor drugs Ligand-induced receptor (IL31RA/OSMRb) dimerization 93-1002Y3-00083 2-plate
93-1002Y3-00084 10-plate
MC4R antagonist drugs β-Arrestin Recruitment 93-0211Y3-00085 2-plate
93-0211Y3-00086 10-plate
NPY2R (β-Arrestin) agonist, antagonist drugs β-Arrestin Recruitment 93-0212Y2-00065 2-plate
93-0212Y2-00066 10-plate
NPY2R (cAMP) agonist, antagonist drugs cAMP Accumulation 95-0077Y2-00055 2-plate
95-0077Y2-00056 10-plate
PD-1 Anti-PD-1, PD-L1 drugs SHP Recruitment 93-1104Y19-00117 2-plate
93-1104Y19-00118 10-plate
PDGFRA antagonist drugs SH2 Recruitment 93-0823Y3-00071 2-plate
93-0823Y3-00072 10-plate
PDGFRB antagonist drugs SH2 Recruitment 93-0493Y3-00073 2-plate
93-0493Y3-00074 10-plate
SIRPa (-CD47) agonists, antagonist drugs SH2 Recruitment 93-1135Y19-00129 2-plate
93-1135Y19-00130 10-plate
SSTR2 agonist drugs β-Arrestin Recruitment 93-0181Y2-00067 2-plate
93-0181Y2-00068 10-plate
TrkB-p75 antagonist drugs SH2 Recruitment 93-0530Y3-00075 2-plate
93-0530Y3-00076 10-plate
TrkC antagonist drugs SH2 Recruitment 93-0464Y3-00077 2-plate
93-0464Y3-00078 10-plate
VIPR2 agonist drugs β-Arrestin Recruitment 93-0317Y2-00087 2-plate
93-0317Y2-00088 10-plate

 

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 0.5 ml Elite Pre-stained Protein Ladder (2 x 0.25 ml) PAL-EPL-500 0.5ml 500
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